Regulated Industries: Healthcare, Finance & Pharma

For organizations operating in highly regulated industries, requirements management isn’t just about building better software—it’s about maintaining compliance, ensuring patient safety, protecting financial data, and surviving regulatory audits. In healthcare, finance, and pharmaceutical sectors, inadequate requirements documentation can result in failed audits, regulatory warnings, product recalls, or even civil penalties.

Catalio provides the structured requirements management, audit trails, and traceability capabilities that regulated organizations need to demonstrate compliance with FDA regulations, HIPAA requirements, SOX controls, GxP standards, and other regulatory frameworks. This guide explores how organizations in these critical industries use Catalio to manage validation documentation, maintain compliance, and ensure regulatory readiness.

Introduction & Regulatory Context

The Compliance Challenge in Regulated Industries

Organizations in regulated industries face a unique set of challenges when developing software systems, medical devices, or data-processing platforms:

Regulatory Requirements: Multiple overlapping regulations (FDA 21 CFR Part 11, HIPAA, SOX, GDPR, GxP) each with specific documentation requirements, validation expectations, and audit readiness standards.

Validation Documentation: Comprehensive documentation packages including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), design specifications, test protocols, validation reports, and traceability matrices.

Change Control: Rigorous change management processes that require impact assessment, approval workflows, regression testing, and documentation updates for every requirements change.

Audit Readiness: Continuous preparation for regulatory inspections, internal audits, and external certifications with complete, traceable, and readily accessible documentation.

Traceability Requirements: End-to-end traceability from business needs through requirements, design, implementation, testing, and validation—with bidirectional links that can be demonstrated during inspections.

Electronic Records: Management of electronic records that meet regulatory requirements for integrity, reliability, and availability while maintaining appropriate access controls and audit trails.

Requirements Management for Validation

In regulated environments, requirements management serves as the foundation of the entire validation lifecycle:

Validation Lifecycle Foundation: Requirements form the basis of validation activities, with User Requirements driving Functional Requirements, which inform Design Specifications, which guide Test Protocols. Each validation artifact traces back to requirements.

Risk Management Integration: Requirements must be linked to risk assessments, with safety-critical and high-risk requirements receiving appropriate scrutiny, additional testing, and comprehensive validation coverage.

Change Impact Analysis: When requirements change, the impact must be assessed across all linked artifacts—design documents, test cases, validation protocols, risk assessments—to ensure nothing falls through the cracks.

Validation Status Tracking: Each requirement must track its validation status—specified, designed, implemented, tested, verified, validated—with clear evidence supporting each stage.

Review and Approval Evidence: Requirements must move through defined review and approval workflows with documented evidence of who reviewed, who approved, when approvals occurred, and what criteria were used.

Audit and Traceability Requirements

Regulatory audits focus heavily on requirements documentation and traceability:

Inspection Expectations: Auditors expect to see complete requirements documentation with clear traceability to design, testing, and validation activities. They look for gaps, inconsistencies, and evidence of change control.

Traceability Matrices: Organizations must produce traceability matrices that demonstrate requirements coverage across the validation lifecycle. Forward traceability (requirements to tests) and backward traceability (tests to requirements) must both be shown.

Change History: Complete audit trails showing all changes to requirements, including what changed, who changed it, when it changed, and why it changed. Change history must be immutable and readily accessible.

Documentation Completeness: Every requirement must have appropriate supporting documentation—acceptance criteria, test cases, validation evidence, and approval records. Missing documentation raises red flags during audits.

Configuration Management: Auditors verify that requirements are under proper configuration management with version control, baseline management, and the ability to reconstruct historical states.

Catalio addresses these regulatory requirements through its structured approach to requirements management, comprehensive audit trails, and built-in traceability features that support compliance across multiple regulatory frameworks.

Healthcare & Medical Devices

The healthcare industry faces some of the most stringent regulatory requirements for software development and medical device manufacturing. Patient safety depends on rigorous requirements management, comprehensive validation, and meticulous documentation.

FDA 21 CFR Part 11 Compliance

FDA’s 21 CFR Part 11 regulation establishes criteria for electronic records and electronic signatures in systems used by organizations subject to FDA regulations:

Electronic Records Requirements: Systems must ensure the integrity, authenticity, and reliability of electronic records throughout their lifecycle. Catalio provides immutable audit trails that track all changes to requirements, including timestamp, user identity, and change description.

Access Controls: Organizations must restrict access to authorized individuals through unique user identifications and passwords. Catalio’s organization-based multi-tenancy ensures complete separation between organizations, while role-based permissions control access within each organization.

Audit Trail Requirements: Part 11 mandates computer-generated, timestamped audit trails documenting operator actions. Catalio automatically captures audit trails for all requirement changes, status updates, relationship modifications, and approval actions—with complete traceability that cannot be disabled or altered.

Record Retention: Electronic records must be retained and readily accessible throughout their retention period. Catalio maintains complete version history with the ability to view requirements as they existed at any point in time, supporting regulatory retention requirements.

Electronic Signatures: While Catalio doesn’t currently implement electronic signatures directly, its audit trails and approval workflows provide the foundation for electronic signature integration. Organizations can integrate third-party electronic signature solutions or use documented manual signature processes.

Validation Requirements: Part 11 requires validation of systems to ensure accuracy, reliability, and consistent intended performance. Catalio’s structured data model, defined workflows, and predictable behavior support validation efforts with clear requirements traceability.

Example Part 11 Use Case: A pharmaceutical manufacturer developing electronic batch record systems uses Catalio to manage User Requirements for their Part 11-compliant system. Each requirement documents the specific Part 11 controls being implemented—audit trail capabilities, access control features, data integrity controls. Requirements link to design specifications that detail how Part 11 requirements are met, and to test protocols that verify Part 11 compliance. During FDA inspections, the traceability matrix demonstrates complete Part 11 coverage.

HIPAA Requirements Management

The Health Insurance Portability and Accountability Act (HIPAA) establishes requirements for protecting patient health information:

Security Rule Requirements: HIPAA’s Security Rule requires organizations to implement administrative, physical, and technical safeguards. Catalio helps organizations document security requirements for systems processing protected health information (PHI).

Access Control Requirements: Systems must implement role-based access controls, unique user identifications, and automatic logoff capabilities. Organizations use Catalio to specify access control requirements with clear acceptance criteria and validation test cases.

Audit Controls: HIPAA requires mechanisms to record and examine system activity. Requirements for audit logging capabilities, audit report generation, and audit review processes can be documented and traced through implementation and testing.

Integrity Controls: Systems must implement controls to ensure that PHI is not improperly altered or destroyed. Integrity requirements specify data validation rules, checksums, and verification procedures with traceability to implementation.

Transmission Security: Requirements for encrypting PHI during transmission, securing communication channels, and verifying message authenticity can be documented with links to design specifications and security test cases.

Privacy Rule Requirements: Organizations document requirements for patient consent management, minimum necessary access controls, and privacy notification capabilities—with traceability to privacy impact assessments and privacy testing.

Example HIPAA Use Case: A healthcare provider implementing an electronic health records (EHR) system uses Catalio to manage HIPAA compliance requirements. Security requirements specify encryption standards, access control mechanisms, and audit logging capabilities. Each requirement links to specific HIPAA Security Rule provisions, design documents detailing implementation approaches, and security test cases verifying compliance. Risk assessments identify high-risk requirements requiring additional validation. During HIPAA security assessments, the organization presents comprehensive traceability matrices demonstrating security control coverage.

IEC 62304 Medical Device Software

IEC 62304 is the international standard for medical device software lifecycle processes:

Software Requirements Specification: IEC 62304 requires detailed software requirements specifications derived from system requirements. Catalio helps organizations manage the hierarchy from system requirements through software requirements to detailed design specifications.

Risk Management Integration: Requirements must be classified according to risk—safety-critical, high-risk, medium-risk, and low-risk. Catalio’s tagging and categorization features support risk classification with filtering and reporting by risk level.

Traceability Requirements: The standard mandates traceability between system requirements, software requirements, risk controls, design specifications, test cases, and validation evidence. Catalio’s relationship management provides the bidirectional traceability IEC 62304 demands.

Change Management: All software changes must be documented with impact analysis, risk assessment, and verification planning. Catalio’s audit trails and version history provide the change documentation IEC 62304 requires.

Software Safety Classification: Organizations must classify software based on potential harm. Requirements can be tagged with safety classifications (Class A, B, or C) with appropriate validation rigor applied to each class.

Verification and Validation: Requirements must specify verification and validation methods. Each requirement in Catalio can link to verification test cases and validation protocols with clear pass/fail criteria.

Example IEC 62304 Use Case: A medical device manufacturer developing insulin pump software uses Catalio to manage software requirements per IEC 62304. System requirements define the overall device functionality and safety requirements. Software requirements break down system requirements into detailed software specifications. Each requirement is classified by risk level (Class C for life-sustaining functions) with corresponding test coverage. Design specifications link to software requirements, while test cases link back to verify implementation. Risk controls are linked to mitigated hazards from ISO 14971 risk analysis. During design reviews, the traceability matrix demonstrates complete coverage of all safety requirements through testing and validation.

Risk Management Integration (ISO 14971)

ISO 14971 establishes a process for managing risks associated with medical devices:

Hazard Analysis Requirements: Organizations document requirements for implementing risk controls identified during hazard analysis. Each risk control becomes a requirement with clear acceptance criteria and validation evidence.

Risk-Based Testing: High-risk requirements receive more comprehensive testing and validation. Catalio’s tagging system allows filtering requirements by risk level to ensure appropriate test coverage.

Residual Risk Evaluation: Requirements for residual risk communication, warning labels, and user training can be documented with links to risk assessment outputs and validation evidence.

Post-Market Surveillance: Requirements for monitoring device performance, collecting user feedback, and analyzing field data support ongoing risk management throughout the device lifecycle.

Risk-Benefit Analysis: Requirements that implement risk mitigation measures link to documented risk-benefit analyses showing that benefits outweigh remaining risks.

Example Risk Management Use Case: A surgical robot manufacturer integrates ISO 14971 risk management with IEC 62304 software development. Each identified hazard from risk analysis generates risk control requirements in Catalio. High-severity hazards (e.g., unintended surgical movement) generate multiple requirements for hardware interlocks, software checks, and operator controls. Requirements are tagged with the hazards they mitigate and linked to verification test cases and validation protocols. Risk management reviews use Catalio’s traceability to verify that all hazards have been addressed through requirements and that all risk controls have been implemented and verified.

Financial Services

Financial institutions face complex regulatory requirements designed to protect customer data, ensure transaction integrity, and maintain financial stability. Requirements management plays a critical role in demonstrating compliance and managing regulatory risk.

SOX Compliance Requirements

The Sarbanes-Oxley Act (SOX) establishes requirements for financial reporting controls and IT systems that support financial processes:

IT General Controls (ITGC): SOX requires documented IT controls over systems that impact financial reporting. Organizations use Catalio to document requirements for access controls, change management, backup and recovery, and system monitoring.

Change Management Requirements: All changes to systems supporting financial reporting must follow documented change control procedures. Requirements specify approval workflows, testing requirements, and documentation standards for system changes.

Access Control Requirements: Systems must restrict access based on job responsibilities with segregation of duties. Requirements document role-based access controls, approval processes for access requests, and periodic access reviews.

Audit Trail Requirements: SOX requires complete audit trails for financial transactions and system changes. Requirements specify logging capabilities, audit report generation, and audit trail retention periods.

Data Integrity Controls: Requirements for validation rules, reconciliation processes, and error handling ensure the accuracy and completeness of financial data.

Backup and Recovery: Requirements for data backup frequency, retention periods, recovery time objectives, and recovery point objectives ensure business continuity and data availability.

Testing and Validation: SOX requires testing of IT controls. Requirements link to control test procedures and validation evidence demonstrating control effectiveness.

Example SOX Use Case: A financial services company implementing a new general ledger system uses Catalio to manage SOX compliance requirements. Access control requirements specify role definitions, segregation of duties rules, and approval workflows for access changes. Change management requirements document the approval process for system changes with mandatory testing and approval gates. Audit trail requirements specify what events must be logged, retention periods, and reporting capabilities. Each requirement links to control descriptions in the SOX compliance documentation and to test procedures verifying control effectiveness. During SOX audits, the organization presents traceability matrices demonstrating that all key controls are implemented and tested.

PCI-DSS for Payment Systems

The Payment Card Industry Data Security Standard (PCI-DSS) establishes security requirements for systems that process, store, or transmit cardholder data:

Cardholder Data Protection: Requirements specify encryption methods for cardholder data at rest and in transit, tokenization approaches, and data retention policies.

Network Security Requirements: Organizations document requirements for firewall configurations, network segmentation, and intrusion detection systems protecting cardholder data environments.

Access Control Requirements: PCI-DSS mandates strict access controls with unique user IDs, multi-factor authentication, and access restrictions. Requirements specify authentication mechanisms, authorization rules, and access review processes.

Security Testing Requirements: Regular security testing including vulnerability scanning and penetration testing must be performed. Requirements document testing frequency, scope, and remediation processes.

Security Monitoring: Requirements for security event logging, log review processes, and security incident response procedures support ongoing security monitoring.

Secure Development: PCI-DSS requires secure coding practices and security testing during development. Requirements management supports this by documenting security requirements with links to security test cases and code review results.

Example PCI-DSS Use Case: An e-commerce platform processing credit card payments uses Catalio to manage PCI-DSS compliance requirements. Encryption requirements specify algorithms (AES-256), key management procedures, and encryption scope for cardholder data. Network segmentation requirements define the cardholder data environment boundaries, firewall rules, and network access controls. Access control requirements document authentication mechanisms (multi-factor authentication), authorization rules (least privilege), and access review frequencies (quarterly). Each requirement links to specific PCI-DSS requirements (e.g., Requirement 3.4 for encryption), security test cases, and validation evidence. During PCI-DSS assessments, the QSA (Qualified Security Assessor) reviews the traceability matrix demonstrating complete requirement coverage.

GDPR and Data Privacy

The General Data Protection Regulation (GDPR) establishes requirements for protecting personal data of EU residents:

Privacy by Design Requirements: GDPR requires privacy considerations throughout system design. Organizations document privacy requirements including data minimization, purpose limitation, and privacy-preserving technologies.

Data Subject Rights: Requirements specify capabilities for data subject access requests, right to erasure (right to be forgotten), right to data portability, and right to rectification.

Consent Management: Requirements document consent collection mechanisms, consent withdrawal processes, and consent audit trails demonstrating compliance with GDPR consent requirements.

Data Breach Notification: Requirements specify breach detection capabilities, notification workflows, and documentation requirements for GDPR’s 72-hour breach notification requirement.

Data Protection Impact Assessments: High-risk data processing requires DPIAs. Requirements can link to DPIA outputs with risk mitigation measures implemented as specific requirements.

International Data Transfers: Requirements for data transfer mechanisms (Standard Contractual Clauses, Binding Corporate Rules) ensure GDPR compliance when transferring data outside the EU.

Example GDPR Use Case: A SaaS company serving EU customers uses Catalio to manage GDPR compliance requirements. Privacy requirements document data minimization practices, specifying what personal data is collected and the lawful basis for processing. Data subject rights requirements specify response timeframes (one month), supported requests types (access, erasure, portability), and verification procedures for requesters. Consent management requirements detail consent collection mechanisms, granular consent options, and consent withdrawal capabilities. Each requirement links to relevant GDPR articles, privacy impact assessment findings, and validation test cases. During GDPR audits by data protection authorities, the organization demonstrates privacy-by-design through comprehensive requirements traceability.

Risk and Control Documentation

Financial institutions must document risks and implement controls to mitigate those risks:

Risk Assessment Requirements: Organizations document requirements for risk identification, risk analysis, and risk evaluation processes that support enterprise risk management.

Control Implementation: Each identified risk requires compensating controls. Control requirements specify the mechanisms, procedures, and technologies implementing risk mitigation measures.

Control Testing: Requirements link to control test procedures and test results demonstrating control effectiveness. Testing frequencies (quarterly, annually) are documented in requirements.

Three Lines of Defense: Requirements support the three lines of defense model with specifications for operational controls (first line), risk management and compliance monitoring (second line), and internal audit capabilities (third line).

Regulatory Reporting: Requirements for regulatory reports (call reports, capital adequacy reports, liquidity reports) ensure accurate and timely regulatory filings.

Example Risk Management Use Case: A regional bank uses Catalio to manage operational risk controls. Each operational risk identified during risk assessment generates control requirements. Credit risk controls specify underwriting criteria, approval authorities, and portfolio monitoring mechanisms. Fraud risk controls document transaction monitoring rules, alert investigation procedures, and fraud reporting workflows. Compliance requirements specify regulatory monitoring capabilities, compliance testing procedures, and regulatory reporting mechanisms. Requirements link to risk register entries, control test procedures, and control effectiveness evidence. During regulatory examinations, examiners review the traceability from identified risks through implemented controls to testing evidence.

Pharmaceutical & Biotechnology

The pharmaceutical and biotechnology industries operate under Good Practice (GxP) regulations that govern drug development, manufacturing, and distribution. Requirements management is central to validation, compliance, and regulatory submissions.

GxP (GMP, GLP, GCP) Requirements

GxP encompasses multiple Good Practice regulations:

Good Manufacturing Practice (GMP): Requirements for manufacturing systems cover batch record accuracy, material traceability, equipment calibration, and quality control testing. Organizations document GMP requirements with links to validation protocols and GMP compliance evidence.

Good Laboratory Practice (GLP): Requirements for laboratory systems specify data integrity controls, instrument qualification procedures, and study documentation standards supporting GLP compliance for non-clinical studies.

Good Clinical Practice (GCP): Requirements for clinical trial management systems document protocol compliance tracking, adverse event reporting, informed consent management, and regulatory submission capabilities.

Data Integrity (ALCOA+): Requirements must demonstrate that data is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA), plus Complete, Consistent, Enduring, and Available. Each requirement specifies data integrity controls relevant to the system function.

Validation Requirements: GxP systems require prospective validation demonstrating that systems consistently produce expected results. Requirements form the basis of validation protocols, with traceability from requirements through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Example GMP Use Case: A pharmaceutical manufacturer developing a Manufacturing Execution System (MES) uses Catalio to manage GMP requirements. Batch record requirements specify electronic batch record capabilities, electronic signature workflows, and recipe management functions. Material traceability requirements document lot tracking, genealogy reporting, and deviation investigation capabilities. Quality control integration requirements specify laboratory result entry, out-of-specification (OOS) investigation workflows, and batch release approval processes. Each requirement links to specific GMP regulations (21 CFR Parts 210/211), design specifications, and validation test cases. During FDA inspections, the organization demonstrates GMP compliance through comprehensive requirements traceability to validation evidence.

Electronic Batch Record Systems

Electronic Batch Record (EBR) systems replace paper batch records in pharmaceutical manufacturing:

Recipe Management Requirements: Requirements specify capabilities for managing master formulas, process parameters, and material lists with version control and approval workflows.

Batch Execution Requirements: Requirements document batch execution capabilities including step-by-step operator instructions, parameter entry and verification, and deviation handling procedures.

Material Dispensing: Requirements for material dispensing functions specify barcode scanning, weight verification, lot number capture, and material substitution controls.

Electronic Signatures: Requirements document electronic signature workflows for batch record review and approval with signature meanings (e.g., “Performed by,” “Verified by,” “Approved by”).

Deviation Management: Requirements specify deviation capture, impact assessment, investigation workflows, and corrective action tracking integrated with batch records.

Batch Genealogy: Requirements for lot traceability specify forward traceability (where materials were used) and backward traceability (where products came from) supporting recall capabilities.

Example EBR Use Case: A biologics manufacturer implementing an EBR system uses Catalio to manage requirements for replacing paper batch records. User Requirements specify high-level capabilities needed by manufacturing, quality assurance, and regulatory affairs. Functional Requirements break down each capability into detailed system functions. Recipe management requirements document version control, parameter ranges, and approval workflows for master batch records. Batch execution requirements specify operator interface design, parameter entry validation, and real-time monitoring displays. Electronic signature requirements document signature workflows, authentication methods, and signature meanings per 21 CFR Part 11. Requirements link through validation protocols to IQ/OQ/PQ documentation. During validation, the traceability matrix demonstrates complete coverage of all GMP requirements.

Clinical Trial Management

Clinical trial management systems support Good Clinical Practice (GCP) compliance:

Protocol Management Requirements: Requirements specify capabilities for managing study protocols, protocol amendments, and protocol deviation tracking with complete audit trails.

Informed Consent: Requirements document electronic informed consent (eConsent) capabilities, consent version management, and subject consent tracking supporting GCP informed consent requirements.

Randomization and Blinding: Requirements for randomization procedures, blinding mechanisms, and emergency unblinding capabilities ensure trial integrity and GCP compliance.

Adverse Event Reporting: Requirements specify adverse event capture, severity assessment, causality determination, and regulatory reporting capabilities within required timeframes.

Data Collection: Electronic Data Capture (EDC) requirements document case report form (CRF) design, data validation rules, query management, and data export capabilities.

Regulatory Submissions: Requirements for regulatory document management specify eCTD (electronic Common Technical Document) generation, submission tracking, and regulatory correspondence management.

Example Clinical Trial Use Case: A biotechnology company developing a Clinical Trial Management System (CTMS) uses Catalio to manage GCP requirements. Protocol management requirements specify version control for protocols, amendment tracking, and deviation documentation. Informed consent requirements document eConsent workflows, subject comprehension verification, and consent audit trails. Adverse event reporting requirements specify event capture forms, severity grading (CTCAE), causality assessment workflows, and automated regulatory reporting to FDA/EMA within required timeframes. Safety monitoring requirements document Data Safety Monitoring Board (DSMB) reporting, interim analysis capabilities, and study stopping rules. Requirements link to ICH-GCP guidelines, design specifications, and validation test cases. During regulatory inspections, the sponsor demonstrates GCP compliance through requirements traceability to validation evidence.

21 CFR Part 11 Validation

Part 11 validation is a comprehensive process demonstrating compliance with FDA’s electronic records and electronic signatures regulation:

Validation Planning: Requirements form the foundation of the validation plan, defining the scope of validation, validation approach (prospective, concurrent, retrospective), and acceptance criteria for validation activities.

User Requirements Specification (URS): The URS documents all user requirements including functional requirements, Part 11 requirements, data integrity requirements, and business process requirements. Each requirement includes acceptance criteria and validation approach.

Functional Requirements Specification (FRS): Functional requirements break down user requirements into detailed system functions with inputs, processing, outputs, and error handling specified for each function.

Design Specification: Design specifications document how functional requirements are implemented including system architecture, database design, interface design, and security controls.

Traceability Matrix: The Requirements Traceability Matrix (RTM) demonstrates bidirectional traceability from user requirements through functional requirements, design specifications, test cases, and test results.

Test Protocols: Requirements link to test protocols (IQ, OQ, PQ) with test cases designed to verify that each requirement is correctly implemented and validated.

Validation Report: The validation report summarizes validation activities, references requirements coverage, presents test results, documents deviations, and concludes whether the system is validated and suitable for intended use.

Example Part 11 Validation: A pharmaceutical company validating a Laboratory Information Management System (LIMS) uses Catalio throughout the validation lifecycle. The validation plan documents the validation approach with requirements serving as the foundation. User Requirements specify laboratory workflows, data integrity controls, audit trail capabilities, and electronic signature requirements. Each requirement includes specific Part 11 controls being implemented (e.g., audit trails per 11.10(e), electronic signatures per 11.50). Functional Requirements detail how each user requirement is implemented with specific system functions. Design Specifications document technical implementation approaches. Test protocols (IQ, OQ, PQ) contain test cases linked to requirements. The Requirements Traceability Matrix generated from Catalio demonstrates that all requirements are covered by test cases and all test cases trace to requirements. The validation report presents the traceability matrix as evidence of validation completeness. During FDA inspections, inspectors review the traceability matrix and validate that requirements are appropriately tested and validation evidence is complete.

Catalio Compliance Features

Catalio is designed with regulated industries in mind, providing features that support compliance, validation, and audit readiness.

Audit Trails and Change History

Comprehensive audit trails are fundamental to regulatory compliance:

Automatic Audit Trail Capture: Catalio automatically captures audit trails for all changes to requirements including requirement creation, content changes, status updates, relationship additions/deletions, and approval actions. Audit trails cannot be disabled, ensuring complete change history.

Immutable Audit Trails: Once captured, audit trails cannot be modified or deleted by users, ensuring data integrity and meeting regulatory requirements for immutable audit trails.

Audit Trail Content: Each audit trail entry includes timestamp (date and time of change), user identity (who made the change), change description (what changed), previous value, new value, and context (which organization, which requirement).

Change Reason Documentation: While not currently enforced, organizations can establish procedures for documenting change reasons in requirement descriptions or through integrated change control systems.

Historical Reconstruction: Complete version history enables reconstruction of requirements at any point in time, supporting regulatory retention requirements and enabling auditors to see requirements as they existed during specific validation activities.

Audit Trail Reporting: Organizations can export audit trail data for audit readiness, compliance reporting, or integration with change management systems.

Compliance Mapping: Audit trails support multiple regulatory requirements including FDA 21 CFR Part 11 (audit trail requirements), HIPAA (security rule audit controls), SOX (IT general controls), and GxP data integrity (audit trail per ALCOA+).

Electronic Signatures (Integration Ready)

While Catalio doesn’t currently implement electronic signatures directly, its architecture supports integration:

Approval Workflows: Catalio’s user assignments and status tracking provide the foundation for approval workflows. Organizations can document approval steps, assign reviewers and approvers, and track approval status.

Audit Trail Foundation: All approval actions are captured in audit trails with user identity and timestamp, providing the foundation for electronic signature meaning (who signed, when they signed, and in what capacity).

Integration Points: Organizations can integrate third-party electronic signature solutions (DocuSign, Adobe Sign, etc.) for formal electronic signatures while using Catalio to manage the requirements content and approval workflows.

Manual Signature Procedures: Until electronic signature integration is implemented, organizations can use documented manual signature procedures with signature logs maintained externally while using Catalio for requirements management.

Future Electronic Signature Support: Catalio’s roadmap includes native electronic signature capabilities with signature meanings (e.g., “Reviewed by,” “Approved by”), authentication requirements, and signature manifestation per Part 11 requirements.

User Access Controls and Permissions

Robust access controls protect requirements data and ensure appropriate segregation of duties:

Organization-Based Multi-Tenancy: Complete data separation between organizations ensures that users from one organization cannot access another organization’s data, supporting multi-tenant SaaS deployments while maintaining regulatory compliance.

Role-Based Access Control: Organizations can assign users to roles (Admin, Contributor, Viewer) with different permission levels controlling who can create, edit, and delete requirements.

User Authentication: Integration with Auth0 provides secure user authentication with support for single sign-on (SSO), multi-factor authentication (MFA), and enterprise identity providers.

Session Management: Secure session management with configurable timeout periods supports HIPAA security requirements and other regulatory access control requirements.

Access Audit Trails: All user access and actions are logged in audit trails, supporting access reviews and security audits required by SOX, HIPAA, and other regulations.

Segregation of Duties: Role-based permissions enable segregation of duties between requirements authors (Contributors), requirements reviewers (Contributors with review responsibilities), and requirements approvers (Admins).

Version Control and Document Management

Comprehensive version control supports configuration management requirements:

Automatic Versioning: All changes to requirements create new versions with complete version history maintained automatically. Users can view any previous version of a requirement.

Version Comparison: Organizations can compare versions to identify what changed between versions, supporting change impact analysis and change control procedures.

Baseline Management: While not yet implemented as a formal feature, organizations can use status fields and tags to mark requirements baselines (e.g., “V1.0 Baseline,” “Approved Baseline”) for configuration management.

Document Relationships: Requirements can be organized hierarchically and linked with relationships, supporting document management practices where specifications trace to higher-level requirements documents.

Export Capabilities: Requirements can be exported for document generation, supporting creation of formal validation documents (URS, FRS, Design Specs) from Catalio-managed requirements.

Configuration Identification: Unique requirement identifiers, version numbers, and metadata support configuration identification required by ISO 13485, IEC 62304, and other quality standards.

Traceability Matrices

Requirements traceability is essential for validation and audit readiness:

Relationship Management: Catalio’s relationship features enable linking requirements to design specifications, test cases, risk controls, and other validation artifacts, creating the foundation for traceability matrices.

Bidirectional Traceability: Relationships are bidirectional, enabling forward traceability (requirements to tests) and backward traceability (tests to requirements) required by IEC 62304, ISO 13485, and other standards.

Traceability Views: Organizations can view all related requirements, enabling impact analysis when requirements change and verification that all requirements are traced through testing.

Traceability Reporting: Export capabilities enable generation of Requirements Traceability Matrices (RTM) for validation documentation and audit readiness.

Gap Analysis: Organizations can identify requirements without test coverage or test cases without requirements, supporting validation completeness verification.

Multi-Level Traceability: Requirements can trace from business needs through user requirements, functional requirements, design specifications, test cases, and validation evidence, supporting multi-level traceability required for complex systems.

Regulatory Traceability: Requirements can link to specific regulatory requirements (FDA guidance, ISO standards, GxP regulations), demonstrating how regulatory requirements are addressed through system requirements and validation.

Validation & Qualification Workflows

Validation is the cornerstone of regulated system development, providing documented evidence that systems meet predetermined specifications and work consistently.

User Requirements Specification (URS)

The URS defines what the system must do from the user’s perspective:

Business Process Requirements: Requirements document the business processes the system must support, describing workflows, user roles, and business rules in business language.

Functional Requirements: High-level functional requirements describe system capabilities needed to support business processes without diving into implementation details.

Regulatory Requirements: Specific requirements addressing regulatory compliance including Part 11 controls, HIPAA security requirements, GxP data integrity controls, and other applicable regulations.

Quality Attributes: Requirements for system qualities including performance (response time, throughput), reliability (uptime, error rates), usability (user interface standards), and maintainability.

Interface Requirements: Requirements for interfaces to other systems including data exchanges, integration points, and interoperability requirements.

Acceptance Criteria: Each requirement includes clear, testable acceptance criteria defining how compliance with the requirement will be verified during validation.

URS in Catalio: Organizations create User Requirements in Catalio with appropriate tags (e.g., “URS,” “User Requirement”) and categories (e.g., “Functional,” “Regulatory,” “Performance”). Each requirement includes description, acceptance criteria, and regulatory rationale. Requirements are organized hierarchically mirroring document structure. Status tracking moves requirements through draft, review, approved states with audit trails capturing review and approval activities.

Example URS Requirement:

Title: Electronic Batch Record Creation
Category: Manufacturing Operations
Tags: URS, GMP, Batch Records

Description:
The system shall provide capabilities for creating electronic batch records from approved master batch records. The system shall enforce that only approved master batch records can be used to create production batch records. The system shall automatically assign unique batch numbers and capture start date/time, operator identity, and product information.

Acceptance Criteria:
- Only approved master batch records appear in the batch creation interface
- Each new batch record receives a unique, system-generated batch number
- Batch creation captures and displays operator name, start date/time, product name, and product code
- Batch creation is logged in audit trail with timestamp and operator identity

Regulatory Rationale:
21 CFR Part 211.188 requires batch production and control records with complete information on manufacture and control of each batch.

Related To:
- Master Batch Record Management (URS-012)
- Electronic Signatures for Batch Records (URS-045)
- Audit Trail Requirements (URS-078)

Functional Requirements Specification (FRS)

The FRS breaks down user requirements into detailed system functions:

Detailed Functional Requirements: Each user requirement decomposes into multiple functional requirements specifying system inputs, processing, outputs, validations, and error handling.

User Interface Requirements: Detailed requirements for screen layouts, field definitions, navigation flows, and user interactions supporting usability and user acceptance.

Business Logic Requirements: Requirements specifying business rules, calculations, validations, and workflows that implement business processes defined in the URS.

Data Requirements: Requirements for data elements, data types, data formats, data validations, and data relationships supporting system functionality.

Reporting Requirements: Detailed requirements for reports, queries, dashboards, and analytics needed to support business operations and regulatory compliance.

Traceability to URS: Each functional requirement traces back to one or more user requirements, demonstrating how user needs are addressed through system functions.

FRS in Catalio: Functional requirements are created in Catalio with relationships linking them to parent user requirements. Tags distinguish functional requirements (e.g., “FRS,” “Functional Requirement”) from user requirements. Detailed descriptions specify inputs, processing, outputs, validations, and error conditions. Acceptance criteria define how each function will be tested during qualification.

Example FRS Requirement:

Title: Master Batch Record Approval Status Verification
Category: Manufacturing Operations > Batch Record Creation
Tags: FRS, Functional Requirement, Validation

Description:
When the batch creation screen is opened, the system shall query the master batch record database and retrieve only master batch records with status = "Approved". The query shall filter by product family if the user has restricted access. The results shall be sorted by product name ascending. If no approved master batch records exist, the system shall display message "No approved batch records available. Please contact Quality Assurance."

Inputs:
- User identity (to determine access restrictions)
- Product family filter (if applicable)

Processing:
- Query master_batch_records table WHERE status = 'Approved'
- Apply product family filter if user has restricted access
- Sort results by product_name ASC
- Return result set or empty set

Outputs:
- List of approved master batch records (product name, product code, version, approval date)
- OR message "No approved batch records available..." if no results

Validations:
- Verify user authentication before query execution
- Verify user has "Batch Creation" permission

Error Handling:
- If database query fails, display "System error. Please contact support." and log error

Acceptance Criteria:
- Test confirms only approved master batch records are displayed
- Test confirms unapproved records do not appear
- Test confirms product family filtering works correctly for restricted users
- Test confirms error message appears when no approved records exist
- Test confirms error handling works when database is unavailable

Traces To:
- Electronic Batch Record Creation (URS-023)

Related To:
- Master Batch Record Approval Workflow (FRS-089)
- User Access Control by Product Family (FRS-142)

Design Specifications

Design specifications document how functional requirements are technically implemented:

System Architecture: High-level architecture describing system components, tiers (presentation, business logic, data), and deployment architecture.

Database Design: Data model documenting database tables, fields, data types, constraints, indexes, and relationships implementing data requirements.

Interface Design: Detailed interface specifications including screen mockups, field definitions, validation rules, and navigation flows.

Security Design: Security controls including authentication mechanisms, authorization rules, encryption implementations, and audit logging.

Algorithm Specifications: Detailed algorithms for calculations, data transformations, and business logic processing implementing functional requirements.

Integration Design: Interface specifications for integration with external systems including data formats, communication protocols, and error handling.

Design Traceability: Each design element traces to functional requirements, demonstrating how requirements are implemented through design decisions.

Design Specifications in Catalio: Organizations can create design specification requirements in Catalio (tagged “Design Spec”) or maintain design specifications in external tools (CAD systems, architecture tools) with references in Catalio requirements. Requirements link to design specifications showing which design elements implement which requirements.

Test Protocols and Validation Plans

Test protocols verify that requirements are correctly implemented:

Validation Plan: The validation plan documents the overall validation approach, validation scope (what’s being validated), validation team roles and responsibilities, validation schedule, and acceptance criteria for validation activities.

Installation Qualification (IQ): IQ protocols verify that the system is installed correctly with all hardware components, software components, and infrastructure configured per specifications. IQ tests verify installation but don’t test functionality.

Operational Qualification (OQ): OQ protocols verify that all system functions work correctly under normal operating conditions. OQ tests verify each functional requirement with test cases covering normal operation, boundary conditions, and error conditions.

Performance Qualification (PQ): PQ protocols verify that the system consistently performs according to specifications in the actual production environment with production data volumes and production workflows.

Test Case Design: Each test case links to specific requirements, documenting test objective, test prerequisites, test steps, expected results, and actual results. Pass/fail criteria are clearly defined.

Test Traceability: Test protocols include traceability matrices showing which test cases verify which requirements, enabling verification that all requirements are tested and all tests trace to requirements.

Test Protocols in Catalio: While test cases are typically managed in dedicated test management tools, requirements in Catalio link to test cases in external systems or document test case references in requirement descriptions. Organizations track validation status using requirement status fields (e.g., “Validated,” “Testing”) and tags indicating validation completion.

Example Test Protocol Structure:

Protocol: OQ-Manufacturing-001: Electronic Batch Record Creation

Requirements Coverage:
- URS-023: Electronic Batch Record Creation
- FRS-087: Master Batch Record Approval Status Verification
- FRS-088: Unique Batch Number Generation
- FRS-089: Batch Creation Data Capture

Test Case OQ-MFG-023-01: Verify Only Approved Master Batch Records Available
Prerequisite: Test database loaded with 3 approved and 2 unapproved master batch records
Linked Requirement: FRS-087

Test Steps:
1. Log in as manufacturing operator
2. Navigate to batch creation screen
3. Observe the list of available master batch records
4. Verify count of displayed records
5. Verify each displayed record shows status "Approved"
6. Verify unapproved records do not appear

Expected Results:
- Batch creation screen displays 3 master batch records
- All displayed records show status = "Approved"
- Product names: "Aspirin 100mg", "Aspirin 250mg", "Ibuprofen 200mg"
- Unapproved records not displayed

Pass/Fail Criteria:
- Pass if exactly 3 approved records displayed and 0 unapproved records displayed
- Fail if unapproved records appear OR if approved records missing

Test Execution:
Executed by: [Name] Date: [Date] Result: [ ] Pass [ ] Fail
Actual Results: [To be completed during test execution]
Deviations: [Document any deviations from expected results]

Reviewed by: [Name] Date: [Date]
Approved by: [Name] Date: [Date]

IQ/OQ/PQ Documentation

The three stages of qualification documentation:

Installation Qualification (IQ) Components:

• Hardware Verification: Document system hardware including servers, network components, workstations with serial numbers, models, and locations
• Software Installation: Document installed software including application software, database software, operating systems with version numbers and installation dates
• Configuration Verification: Document system configuration including server settings, database parameters, security settings, and network configuration
• Documentation Review: Verify all required documentation is available including URS, FRS, Design Specifications, and test protocols
• Training Records: Verify validation team members have received appropriate training

Operational Qualification (OQ) Components:

• Functional Testing: Test all functional requirements from FRS with test cases covering normal operation, boundary conditions, and error handling
• Security Testing: Verify access controls, authentication mechanisms, authorization rules, and audit trails work correctly
• Interface Testing: Verify interfaces to external systems work correctly with data flowing correctly in both directions
• Report Testing: Verify all reports generate correctly with accurate data and proper formatting
• Backup and Recovery: Verify backup procedures work correctly and recovery procedures successfully restore data

Performance Qualification (PQ) Components:

• Production Environment Testing: Execute critical business processes in production environment with production data volumes
• Concurrent User Testing: Verify system performance with expected number of concurrent users
• Stress Testing: Verify system handles peak loads and degrades gracefully under excessive load
• Integration Testing: Verify end-to-end workflows spanning multiple systems work correctly in production environment
• Business Process Validation: Verify that business processes are accurately implemented and users can successfully complete their work

Documentation in Catalio: Requirements track their qualification status using custom fields or tags (e.g., “IQ Complete,” “OQ Complete,” “PQ Complete”). Requirements link to IQ/OQ/PQ protocol sections and test case numbers. Validation summary information can be documented in requirement metadata. Organizations generate validation summary reports showing requirements coverage across IQ/OQ/PQ activities.

Real-World Example: Medical Device Software

This comprehensive example demonstrates how a medical device manufacturer uses Catalio throughout the IEC 62304 software development lifecycle for an implantable cardiac monitor.

Initial Risk Assessment

The project begins with ISO 14971 risk analysis identifying hazards:

Hazard Identification:

Hazard H-001: Failure to Detect Cardiac Arrhythmia
Severity: Catastrophic (death or serious injury)
Probability: Remote
Risk Level: High
Risk Control Measures Required: Yes

Hazard H-002: False Arrhythmia Alert
Severity: Moderate (medical intervention required)
Probability: Probable
Risk Level: Medium
Risk Control Measures Required: Yes

Hazard H-003: Data Loss from Device Memory
Severity: Moderate (loss of diagnostic data)
Probability: Remote
Risk Level: Medium
Risk Control Measures Required: Yes

Hazard H-004: Unauthorized Access to Patient Data
Severity: Moderate (privacy breach)
Probability: Remote
Risk Level: Medium
Risk Control Measures Required: Yes

Risk Control Requirements: Each hazard generates risk control requirements documented in Catalio:

Requirement RC-001: Arrhythmia Detection Algorithm Validation
Category: Safety Controls
Tags: Risk Control, Hazard H-001, Safety Critical, IEC 62304 Class C

Description:
The system shall implement a validated arrhythmia detection algorithm with sensitivity ≥95% and specificity ≥98% for detecting ventricular tachycardia and ventricular fibrillation. The algorithm shall be validated against a reference database of at least 1000 annotated ECG recordings representing diverse patient populations and arrhythmia types.

Risk Mitigation:
Mitigates Hazard H-001 (Failure to Detect Cardiac Arrhythmia) by ensuring high sensitivity for life-threatening arrhythmias.

Acceptance Criteria:
- Algorithm achieves sensitivity ≥95% on validation database
- Algorithm achieves specificity ≥98% on validation database
- Validation database includes at least 1000 recordings
- Validation database represents diverse ages, genders, and cardiac conditions
- Validation results documented in validation report
- Algorithm performance verified during PQ testing

IEC 62304 Classification: Class C (Safety-critical software)
ISO 14971 Risk Control: Yes (controls H-001)

Related To:
- ECG Signal Processing Requirements (FRS-201)
- Arrhythmia Classification Requirements (FRS-205)
- Algorithm Performance Test Protocol (OQ-SW-201)

Requirements Development per IEC 62304

Following IEC 62304 requirements process:

System Requirements (Catalio Category: “System Requirements”):

Requirement SYS-001: Continuous Cardiac Monitoring
Category: System Requirements
Tags: System Requirement, IEC 62304 Level 1

Description:
The cardiac monitor system shall continuously monitor the patient's cardiac rhythm 24 hours per day, 7 days per week for up to 3 years of device battery life. The system shall detect, classify, and store significant cardiac events for physician review.

User Need:
Physicians need continuous long-term cardiac monitoring for patients with suspected arrhythmias to diagnose intermittent events that may not occur during brief monitoring periods.

Acceptance Criteria:
- Device operates continuously for 3 years on single battery
- Device detects and stores all significant arrhythmias
- Physician can retrieve stored events for diagnosis

Related To:
- Battery Life Requirements (SYS-005)
- Event Detection Requirements (SYS-010)
- Data Retrieval Requirements (SYS-015)

Software Requirements (Catalio Category: “Software Requirements”):

System requirements decompose into detailed software requirements:

Requirement SW-001: Real-Time ECG Acquisition
Category: Software Requirements > Signal Acquisition
Tags: Software Requirement, IEC 62304 Level 2, Class C

Description:
The software shall continuously acquire ECG signals from the sensing electrodes at a sampling rate of 256 Hz with 16-bit resolution. The software shall apply anti-aliasing filtering before sampling and implement gain control to maintain signal amplitude within ADC range.

Traces To:
- Continuous Cardiac Monitoring (SYS-001)

Acceptance Criteria:
- Sampling rate = 256 Hz ±1%
- ADC resolution = 16 bits
- Anti-aliasing filter cutoff = 125 Hz
- Gain control maintains signal amplitude 20-80% of ADC range
- ECG acquisition verified during IQ with signal generator

Risk Classification: Class C (required for safety-critical arrhythmia detection)

Related To:
- Signal Filtering Requirements (SW-002)
- Arrhythmia Detection Requirements (SW-010)

Requirement SW-010: Ventricular Tachycardia Detection
Category: Software Requirements > Arrhythmia Detection
Tags: Software Requirement, IEC 62304 Level 2, Class C, Risk Control

Description:
The software shall detect ventricular tachycardia (VT) episodes defined as ≥3 consecutive ventricular beats with heart rate ≥100 bpm and QRS duration ≥120 ms. The software shall classify VT severity (non-sustained VT <30 seconds, sustained VT ≥30 seconds). The software shall store the full ECG waveform for all detected VT episodes.

Algorithm Specification:
- QRS detection using Pan-Tompkins algorithm
- Heart rate calculation from R-R intervals
- QRS duration measurement from Q wave onset to S wave offset
- Beat classification (ventricular vs. supraventricular) using morphology analysis
- VT detection requires 3 consecutive ventricular beats with HR ≥100 bpm

Traces To:
- Continuous Cardiac Monitoring (SYS-001)
- Arrhythmia Detection Algorithm Validation (RC-001)

Risk Control:
Implements risk control RC-001 mitigating Hazard H-001 (Failure to Detect Cardiac Arrhythmia)

Acceptance Criteria:
- VT detection sensitivity ≥95% on validation database
- VT detection specificity ≥98% on validation database
- VT episodes classified correctly (non-sustained vs. sustained)
- Full ECG waveform stored for all VT episodes (30 seconds before, 30 seconds after)
- VT detection verified during OQ with test waveforms and PQ with clinical data

Risk Classification: Class C (Safety-critical - failure could result in missed diagnosis)

Related To:
- QRS Detection Requirements (SW-011)
- Beat Classification Requirements (SW-012)
- Event Storage Requirements (SW-020)
- Algorithm Validation Protocol (OQ-SW-201)

Design Controls and Traceability

IEC 62304 requires comprehensive traceability:

Traceability Matrix in Catalio:

Catalio’s relationship features implement the traceability matrix:

System Requirement SYS-001: Continuous Cardiac Monitoring
├─ Software Requirement SW-001: Real-Time ECG Acquisition
│  ├─ Design Specification DS-001: ECG Front-End Design
│  │  └─ Test Case IQ-HW-001: Verify ECG Sampling Rate
│  └─ Design Specification DS-002: Anti-Aliasing Filter Design
│     └─ Test Case IQ-HW-002: Verify Filter Frequency Response
│
├─ Software Requirement SW-010: Ventricular Tachycardia Detection
│  ├─ Design Specification DS-010: Pan-Tompkins QRS Detector
│  │  └─ Test Case OQ-SW-101: Verify QRS Detection Performance
│  ├─ Design Specification DS-011: Beat Classification Algorithm
│  │  └─ Test Case OQ-SW-102: Verify Beat Classification Accuracy
│  ├─ Design Specification DS-012: VT Detection Logic
│  │  └─ Test Case OQ-SW-103: Verify VT Detection Criteria
│  └─ Risk Control RC-001: Arrhythmia Detection Algorithm Validation
│     └─ Test Case PQ-CL-201: VT Detection Clinical Validation
│
└─ Software Requirement SW-020: Event Storage
   ├─ Design Specification DS-020: Event Memory Management
   │  └─ Test Case OQ-SW-201: Verify Event Storage Capacity
   └─ Risk Control RC-003: Data Loss Prevention
      └─ Test Case OQ-SW-202: Verify Memory Redundancy

Traceability Views: Requirements in Catalio display all related requirements, enabling:

• Forward Traceability: From system requirements through software requirements to design specifications to test cases
• Backward Traceability: From test cases back through design specifications to software requirements to system requirements
• Risk Control Traceability: From hazards through risk controls to implementing requirements to verification test cases

Traceability Reporting: Organizations export traceability data from Catalio to generate formal Requirements Traceability Matrices for design history files and regulatory submissions.

Verification and Validation Planning

V&V planning defines how requirements will be verified:

Verification Methods: Each requirement specifies verification method:

Requirement SW-010: Ventricular Tachycardia Detection

Verification Methods:
1. Analysis: Algorithm verification using mathematical analysis and simulation
2. Testing: Automated test suite with reference ECG database
3. Inspection: Code review verifying algorithm implementation matches specification

Verification Activities:
- Algorithm Simulation (Analysis): Verify algorithm logic with simulated waveforms
- Unit Testing: Verify individual algorithm components (QRS detector, beat classifier, VT logic)
- Integration Testing: Verify VT detection with full signal processing chain
- Performance Testing: Verify VT detection performance on validation database (1000+ recordings)
- Code Review: Verify implementation matches design specification

Verification Schedule:
- Algorithm Simulation: Sprint 5
- Unit Testing: Continuous (with each code commit)
- Integration Testing: Sprint 8
- Performance Testing: Sprint 10
- Code Review: Sprint 10

Verification Exit Criteria:
- All unit tests pass (100% pass rate)
- Integration tests pass (100% pass rate)
- VT detection sensitivity ≥95% on validation database
- VT detection specificity ≥98% on validation database
- Code review identifies no critical or high-severity defects
- All identified defects resolved and retested

Validation Method:
- Performance Qualification (PQ) with clinical data from pilot implants
- Validation exit criteria: VT detection performance maintained in clinical environment

Test Protocol References: Requirements link to detailed test protocols:

Requirement SW-010: Ventricular Tachycardia Detection

Test Protocols:
- OQ-SW-103: VT Detection Verification Testing
  - Test Cases: OQ-SW-103-01 through OQ-SW-103-25
  - Covers: Normal operation, boundary conditions, error conditions
- OQ-SW-201: Algorithm Performance Validation
  - Test Cases: OQ-SW-201-01 through OQ-SW-201-10
  - Covers: Sensitivity, specificity, positive predictive value, negative predictive value
- PQ-CL-201: Clinical Validation Testing
  - Test Cases: PQ-CL-201-01 through PQ-CL-201-05
  - Covers: Real-world performance with pilot implant patients

Change Management Process

IEC 62304 requires rigorous change management:

Change Request: When a requirement change is proposed:

Change Request CR-045: Modify VT Detection Heart Rate Threshold

Originator: Dr. Sarah Chen, Clinical Affairs
Date: 2024-06-15

Current Requirement (SW-010):
"The software shall detect ventricular tachycardia (VT) episodes defined as ≥3 consecutive
ventricular beats with heart rate ≥100 bpm..."

Proposed Change:
Change VT detection heart rate threshold from ≥100 bpm to ≥120 bpm based on clinical feedback
that current threshold generates excessive false alerts for sinus tachycardia during exercise.

Rationale:
Clinical pilot data shows false positive rate of 12% at ≥100 bpm threshold, primarily from
exercise-induced sinus tachycardia. Clinical literature suggests ≥120 bpm threshold provides
better specificity while maintaining sensitivity for clinically significant VT.

Change Impact Assessment Required: Yes (safety-critical requirement)

Impact Analysis: Change impact is assessed using Catalio’s traceability:

Change Impact Analysis: CR-045

Affected Requirements:
- SW-010: Ventricular Tachycardia Detection (direct change)
- RC-001: Arrhythmia Detection Algorithm Validation (risk control - requires re-assessment)
- SW-012: Beat Classification Requirements (related - no change needed)

Affected Design Specifications:
- DS-012: VT Detection Logic (algorithm parameter change required)

Affected Risk Controls:
- RC-001: Risk control effectiveness must be re-evaluated with new threshold
- Hazard H-001: Residual risk must be re-assessed

Affected Test Cases:
- OQ-SW-103: VT Detection Verification Testing (test cases require update)
- OQ-SW-201: Algorithm Performance Validation (re-execution required)
- PQ-CL-201: Clinical Validation Testing (may require additional testing)

Affected Documentation:
- Software Requirements Specification (section 3.2.10)
- Design Specification Document (section 4.3.5)
- OQ Test Protocol (test cases 103-01 through 103-25)
- Validation Report (appendix B - performance results)

Regression Testing Required:
- Full VT detection test suite (OQ-SW-103)
- Algorithm performance validation (OQ-SW-201)
- Arrhythmia detection integration tests

Risk Assessment:
- Change affects safety-critical requirement (Class C)
- Change affects risk control for Hazard H-001
- Risk re-assessment required before implementation

Approval Required:
- Software Engineering Manager
- Clinical Affairs Director
- Quality Assurance Manager
- Regulatory Affairs Manager

Estimated Effort:
- Requirements Update: 2 hours
- Design Update: 4 hours
- Implementation: 8 hours
- Test Case Updates: 8 hours
- Test Execution: 16 hours
- Documentation Updates: 8 hours
- Risk Re-Assessment: 4 hours
Total: 50 hours

Change Implementation: After approval, changes are implemented with full traceability:

1. Requirement Update: SW-010 updated in Catalio with audit trail capturing change, approvers, and change rationale
2. Design Update: DS-012 design specification updated with new threshold parameter
3. Implementation: Code updated with new parameter value
4. Test Updates: Test cases updated to reflect new threshold
5. Risk Re-Assessment: ISO 14971 risk analysis updated, residual risk re-evaluated
6. Regression Testing: Full test suite executed, results documented
7. Documentation Updates: All affected documents updated with change history noted
8. Change Closure: Change request marked complete with all traceability verified

Catalio Change Management: Catalio’s audit trails automatically document requirement changes, providing the change history required by IEC 62304. Organizations supplement Catalio’s audit trails with formal change control procedures documenting change rationale, impact analysis, approvals, and verification activities.

Regulatory Submission Preparation

The requirements managed in Catalio support regulatory submissions:

510(k) Submission Preparation: For FDA 510(k) premarket notification:

Device Description Section: Export requirements to support device description:

• System requirements define device functionality and intended use
• Software requirements document software features and capabilities
• Requirements organized by device function for clear presentation

Substantial Equivalence Section: Requirements support substantial equivalence comparison:

• Requirements comparison between new device and predicate device
• Identification of similarities and differences in functionality
• Documentation of technological characteristics

Software Documentation: IEC 62304 documentation generated from Catalio requirements:

• Software Requirements Specification (export of software requirements)
• Requirements Traceability Matrix (export of requirement relationships)
• Software Verification and Validation documentation (references to requirements)

Risk Analysis Section: ISO 14971 risk analysis references requirements:

• Risk control requirements document how hazards are mitigated
• Traceability from hazards to risk controls to requirements to verification
• Residual risk evaluation references requirements addressing risks

Clinical Data Section: Requirements support clinical evaluation:

• Requirements define device performance specifications
• Validation acceptance criteria from requirements
• Clinical validation data demonstrates requirements are met

PMA Submission Preparation: For FDA Premarket Approval:

PMA submissions require more comprehensive documentation with requirements playing a central role:

• Technical Section: Complete requirements documentation (URS, FRS, Design Specs)
• Verification and Validation: Comprehensive V&V documentation referencing requirements
• Risk Analysis: Complete ISO 14971 risk analysis with risk control requirements
• Software Documentation: IEC 62304 complete software documentation package
• Clinical Data: Clinical trials demonstrating device meets specified requirements

EU MDR Submission Preparation: For EU Medical Device Regulation compliance:

• Technical Documentation: Requirements documentation per Annex II, Section 1
• Risk Management: ISO 14971 risk management file with risk control requirements
• Clinical Evaluation: Clinical evaluation report referencing device requirements
• Quality Management: ISO 13485 QMS documentation with requirements traceability

Catalio in Submissions: Organizations export requirements from Catalio to create formal submission documents. Requirements traceability matrices demonstrate comprehensive device development with full traceability from intended use through requirements to verification. Audit trails provide evidence of design control processes and change management.

Real-World Example: Banking Application

This example demonstrates how a financial institution uses Catalio to manage SOX compliance requirements for a new online banking platform.

SOX Control Requirements

The bank identifies IT General Controls required for SOX compliance:

Access Control Requirements:

Requirement SOX-AC-001: Role-Based Access Control
Category: IT General Controls > Access Control
Tags: SOX, ITGC, Access Control, Critical Control

Description:
The online banking system shall implement role-based access control (RBAC) restricting access to system functions based on user job responsibilities. The system shall support the following roles with corresponding access permissions:

- Customer Service Representative: View customer accounts, view transactions, create service requests
- Branch Manager: All CSR permissions plus approve wire transfers <$50,000
- Operations Manager: View system logs, run reports, configure system parameters
- System Administrator: All permissions including user management and system configuration
- Auditor (Read-Only): View all data, view all logs, run all reports (no modification access)

Access Permissions shall enforce segregation of duties with the following restrictions:
- Users who can create wire transfers cannot approve wire transfers
- Users who can modify system parameters cannot execute transactions
- Users who can create users cannot approve user access requests

Acceptance Criteria:
- System implements all defined roles with specified permissions
- System enforces segregation of duties rules preventing conflicting role assignments
- Attempting to access unauthorized functions displays "Access Denied" message and logs security event
- User access verified during UAT and validated during OQ testing

SOX Control Mapping:
- Control AC-1: System access is restricted to authorized users
- Control AC-2: Users have minimum access necessary for job responsibilities
- Control AC-3: Segregation of duties prevents fraud and errors

Audit Evidence:
- User role matrix documenting roles and permissions
- Access control test results from OQ testing
- Access review reports (quarterly)
- Access violation log demonstrating access control enforcement

Change Management Requirements:

Requirement SOX-CM-001: Change Control Process
Category: IT General Controls > Change Management
Tags: SOX, ITGC, Change Control, Critical Control

Description:
All changes to the online banking system (application code, database schema, system configuration, infrastructure) shall follow a documented change control process. The change control process shall include:

1. Change Request Submission: Requester documents change description, business justification, and urgency
2. Change Impact Assessment: Technical team assesses impact on system functionality, interfaces, security, and controls
3. Change Approval: Changes require approval from:
   - Technical Manager (all changes)
   - Business Owner (changes affecting business functionality)
   - Security Officer (changes affecting security controls)
   - Compliance Officer (changes affecting SOX controls or audit trails)
4. Testing: All changes require testing in non-production environment with test results documented
5. Change Implementation: Changes deployed to production following deployment procedures
6. Post-Implementation Review: Change results validated, rollback plan executed if needed

Emergency changes (production issues affecting availability or data integrity) may bypass normal approval process but require:
- Emergency approval from Technical Manager and Business Owner
- Full impact assessment and approval within 24 hours
- Retroactive documentation of emergency change rationale
- Post-implementation review within 48 hours

Acceptance Criteria:
- Change management system enforces approval workflow before production deployment
- All changes have documented approvals from required approvers
- All changes have test results documented before production
- Emergency changes have retroactive documentation within required timeframes
- Change control process validated during OQ testing

SOX Control Mapping:
- Control CM-1: System changes are authorized before implementation
- Control CM-2: Changes are tested before production deployment
- Control CM-3: Change history is maintained with full audit trail

Audit Evidence:
- Change management system logs showing approval workflow
- Change request records with approvals and test results
- Production deployment logs
- Emergency change retrospective documentation
- Change control testing results from OQ

Security and Privacy Requirements

Security requirements protect customer financial data:

Requirement SEC-001: Multi-Factor Authentication
Category: Security Controls > Authentication
Tags: Security, Authentication, Customer Facing

Description:
The online banking system shall implement multi-factor authentication (MFA) for all customer login sessions. MFA shall require:
1. First Factor: Username and password (something you know)
2. Second Factor: One of the following (something you have):
   - SMS one-time password (OTP) sent to registered mobile number
   - Authentication app OTP (Google Authenticator, Authy)
   - Hardware security token
   - Biometric authentication (fingerprint, face recognition) on supported devices

MFA Enrollment:
- Customers must enroll at least one second factor during account setup
- Customers may enroll multiple second factors for backup access
- Customers can manage enrolled factors through security settings

MFA Login Flow:
1. Customer enters username and password
2. System validates first factor
3. System prompts for second factor based on customer's enrolled methods
4. Customer provides second factor (enters OTP or completes biometric authentication)
5. System validates second factor
6. System grants access if both factors valid

Failed Authentication:
- Failed first factor: Account locked after 5 failed attempts within 15 minutes
- Failed second factor: Account locked after 3 failed attempts within 15 minutes
- Account unlock requires customer service verification or 24-hour automatic unlock

Acceptance Criteria:
- All customer login attempts require MFA
- All supported second factors function correctly
- Failed authentication locks accounts per specified thresholds
- MFA tested during UAT and validated during security testing

Related To:
- Account Lockout Requirements (SEC-002)
- Session Management Requirements (SEC-010)
- Audit Logging for Authentication (SEC-050)

Compliance Documentation

Requirements link to compliance documentation:

Control Testing Documentation:

Requirement SOX-AC-001: Role-Based Access Control

Control Testing Documentation:

Test 1: Access Control Design
Test Procedure: Review user role matrix and access control configuration
Test Frequency: Annually
Test Execution Date: 2024-Q2
Test Results:
- User role matrix reviewed and found complete with all roles documented
- Access control configuration matches role matrix
- Segregation of duties rules configured correctly
Test Conclusion: Control designed effectively

Test 2: Access Control Operating Effectiveness
Test Procedure:
- Select sample of 25 users across all roles
- Verify user access matches assigned role
- Test segregation of duties by attempting conflicting transactions
- Review access violation log for unauthorized access attempts
Test Frequency: Quarterly
Test Execution Dates: 2024-Q1, 2024-Q2, 2024-Q3, 2024-Q4
Test Results:
- Q1: 25/25 users have correct access, 0 exceptions
- Q2: 25/25 users have correct access, 0 exceptions
- Q3: 24/25 users have correct access, 1 exception (corrected)
- Q4: 25/25 users have correct access, 0 exceptions
Test Conclusion: Control operating effectively

Exception Detail (Q3):
- User: John Smith (Operations Manager)
- Issue: User had System Administrator role in addition to Operations Manager role
- Root Cause: User promoted to System Administrator but previous role not removed
- Remediation: Removed Operations Manager role, updated user access procedures
- Retest: Access verified correct after remediation

Audit Evidence Collection: Catalio requirements link to audit evidence:

• Control Descriptions: Requirements serve as control descriptions for SOX documentation
• Control Testing: Requirements reference control test procedures and results
• Traceability: Requirements trace to control test evidence and audit work papers
• Compliance Reporting: Requirements data exported for SOX compliance reporting

Audit Preparation

Requirements support audit readiness:

Internal Audit Preparation:

Before internal SOX audits, the organization reviews requirements documentation:

1. Control Coverage: Verify all key controls have documented requirements
2. Requirements Currency: Verify requirements are up-to-date with no outdated information
3. Traceability Completeness: Verify requirements trace to control testing documentation
4. Evidence Availability: Verify audit evidence referenced in requirements is available and organized
5. Change Documentation: Verify any control changes during the period are documented with impact assessment

External Audit Preparation:

For external SOX audits (Big 4 accounting firms), requirements documentation supports auditors:

Auditor Walkthroughs: Requirements documentation supports control walkthroughs:

• Auditors review requirement descriptions to understand control design
• Requirements link to process documentation showing how controls are implemented
• Requirements reference system documentation showing technical implementation

Control Testing: Auditors use requirements during control testing:

• Requirements define control objectives and acceptance criteria
• Requirements link to control testing procedures used by auditors
• Requirements reference evidence auditors need to examine

Issue Remediation: If auditors identify control deficiencies:

• Requirements are updated to address identified gaps
• Impact assessment identifies related requirements needing updates
• Change management process documents control improvements
• Requirements link to remediation evidence for auditor review

Example Audit Scenario:

External Audit Finding: Change Management Control Deficiency

Auditor Observation:
During testing of change management controls (SOX-CM-001), the auditor identified 3 of 25 sampled
changes that did not have documented approval from the Compliance Officer despite affecting
SOX-related audit trail functionality.

Management Response:
The change management system was updated to enforce Compliance Officer approval for all changes
tagged as "SOX-Related" or "Audit Trail." Requirements SOX-CM-001 was updated to clarify that
system changes affecting audit trails require Compliance Officer approval. Enhanced change
classification procedures were implemented with mandatory SOX impact assessment during change
intake.

Remediation Actions:
1. Updated Requirement SOX-CM-001 with enhanced approval requirements
2. Modified change management system to enforce SOX-related approval workflow
3. Retroactively obtained Compliance Officer approval for the 3 identified changes
4. Implemented change classification training for technical staff
5. Enhanced change request form with SOX impact assessment section

Remediation Evidence:
- Updated requirement SOX-CM-001 (version 2.1, approved 2024-07-15)
- Change management system configuration showing enhanced workflow
- Retroactive Compliance Officer approvals for changes CR-234, CR-256, CR-289
- Training records for technical staff (20 staff trained, 2024-07-20)
- Enhanced change request form (version 3.0, effective 2024-07-25)

Auditor Validation:
Auditor retested 15 changes after remediation and found 15/15 had appropriate Compliance Officer
approvals. Control deficiency closed effective 2024-08-01.

The requirements in Catalio provided the foundation for identifying the control gap, documenting remediation actions, and demonstrating control improvement to auditors.

Integration with Quality Systems

Regulated organizations typically use Quality Management Systems (QMS) and other enterprise systems for managing quality processes. Catalio integrates with these systems to provide comprehensive quality and compliance management.

ServiceNow for Change Management

Many regulated organizations use ServiceNow for IT Service Management and change management:

Integration Approach:

Bidirectional Integration: Requirements in Catalio link to change requests in ServiceNow:

• Catalio requirements reference ServiceNow change request numbers
• ServiceNow change requests link back to Catalio requirements being changed
• Change impact analysis in ServiceNow references affected Catalio requirements

Change Workflow: When requirements change, the workflow includes both systems:

1. Change Request Creation: User creates change request in ServiceNow documenting proposed requirement change
2. Impact Assessment in Catalio: User identifies affected requirements in Catalio using relationship features to find related requirements, test cases, and design specifications
3. Impact Documentation in ServiceNow: User documents impact assessment findings in ServiceNow change request
4. Change Approval: Change request moves through ServiceNow approval workflow with required approvers
5. Requirements Update in Catalio: After approval, requirements are updated in Catalio with ServiceNow change request number in requirement metadata
6. Change Implementation: Technical changes implemented with traceability to ServiceNow change and Catalio requirements
7. Change Closure: ServiceNow change request closed with reference to updated Catalio requirements and verification evidence

Integration Implementation Options:

Manual Integration (Current):

• Users manually reference ServiceNow change requests in Catalio requirement descriptions
• Users manually link Catalio requirements in ServiceNow change request notes
• Impact analysis performed manually by reviewing Catalio requirement relationships

API Integration (Future):

• Catalio API integration with ServiceNow Change Management module
• Automatic bidirectional linking between change requests and requirements
• Change status synchronization between systems
• Automated impact analysis querying Catalio requirement relationships from ServiceNow

Document Management Systems

Organizations use Document Management Systems (DMS) or Electronic Document Management Systems (EDMS) for controlled documents:

Integration Pattern:

Requirements as Source: Catalio serves as the source of truth for requirements, with formal documents generated from Catalio data:

1. Requirements Development: Requirements developed in Catalio with collaboration, review, and approval workflows
2. Document Generation: Formal requirements documents (URS, FRS) generated from Catalio by exporting requirements and formatting per document templates
3. Document Management: Generated documents uploaded to DMS for document control (version management, approval workflow, distribution)
4. Traceability Maintenance: Requirements in Catalio reference document numbers and versions in DMS; documents in DMS reference Catalio as source

Document Control Workflow:

Process: User Requirements Specification (URS) Document Control

1. Requirements Development (Catalio):
   - Requirements developed in Catalio with status "Draft"
   - Requirements reviewed by stakeholders using Catalio collaboration features
   - Requirements approved by changing status to "Approved"

2. Document Generation:
   - Export requirements from Catalio (filtered by tag "URS")
   - Format requirements per URS document template
   - Generate URS document (Word/PDF) with requirement content from Catalio
   - Add document metadata (document number, version, author, date)

3. Document Approval (DMS):
   - Upload URS document to DMS as "Draft"
   - Initiate document approval workflow in DMS
   - Document routed to approvers (Technical Lead, Quality Manager, Regulatory Affairs)
   - Approvers review document and provide electronic signatures
   - Document status changed to "Approved" in DMS

4. Document Release (DMS):
   - Approved URS document assigned document number (e.g., "DOC-URS-001")
   - Document version finalized (e.g., "Version 1.0")
   - Document distributed to relevant personnel
   - Previous document versions obsoleted

5. Traceability Update (Catalio):
   - Requirements in Catalio updated with document reference (DOC-URS-001, Version 1.0)
   - Requirements now reference both Catalio requirement IDs and DMS document number

6. Change Management:
   - When requirements change, change request created
   - After approval, requirements updated in Catalio
   - Document regenerated from updated Catalio requirements
   - Document version incremented in DMS (Version 1.0 → Version 1.1)
   - Requirements updated with new document version reference

Benefits of Integration:

• Catalio provides agile requirements management with collaboration and traceability
• DMS provides formal document control with approval workflows and version management
• Organizations meet regulatory requirements for controlled documents while maintaining flexibility
• Single source of truth (Catalio) feeds formal documentation system (DMS)

Quality Management Systems (QMS)

QMS platforms (like MasterControl, Veeva, TrackWise) manage quality processes including CAPA, deviation management, and document control:

Integration Areas:

CAPA Integration: When Corrective and Preventive Actions (CAPA) require requirements changes:

CAPA-2024-0156: Customer Complaint - Mobile App Transaction Timeout

Investigation:
Customer complaints indicate mobile banking app times out during large fund transfers
(>$10,000) causing transaction failures and customer frustration. Root cause analysis
identified that session timeout requirement (SEC-010) specifies 5-minute timeout for
all transactions, which is insufficient for large transfers requiring additional
verification steps.

Corrective Action:
Update session timeout requirements (SEC-010) to extend timeout to 15 minutes for
transactions requiring additional verification (large transfers, wire transfers,
external account transfers).

Catalio Actions:
1. Create change request in ServiceNow linking to CAPA-2024-0156
2. Update requirement SEC-010 in Catalio with extended timeout specification
3. Identify related requirements through Catalio relationships (authentication, security)
4. Update test cases for session timeout testing
5. Link updated requirements to CAPA record

QMS Actions:
1. Document requirement change in CAPA record
2. Reference updated Catalio requirement (SEC-010 v2.1)
3. Track verification of change effectiveness
4. Close CAPA after verification testing confirms issue resolved
```text

**Deviation Management:** When manufacturing or quality deviations identify requirement gaps:

```text
Deviation DEV-2024-0432: Batch Record Discrepancy

Description:
Electronic batch record for Batch LOT-45678 shows material dispensing weight (245.8 kg)
exceeds specification (240 kg ±2%). Investigation found that requirement SW-145 (material
dispensing validation) does not include upper bound validation, only lower bound.

Investigation Findings:
- Requirement SW-145 specifies validation for material weights below specification
- Requirement does not specify validation for material weights above specification
- System allows operator to proceed with over-spec material weights
- Over-spec materials can impact product quality

Corrective Action:
Update requirement SW-145 to include both lower bound and upper bound validation for
material weights. System shall prevent batch progression if material weight is outside
specification range (±2%).

Catalio Actions:
1. Update requirement SW-145 with upper bound validation specification
2. Link requirement to deviation record DEV-2024-0432
3. Update related test cases for material dispensing validation
4. Add traceability to quality specification documents

QMS Actions:
1. Document requirement gap in deviation record
2. Reference updated Catalio requirement (SW-145 v1.3)
3. Track implementation of updated validation logic
4. Verify correction through re-qualification testing
5. Close deviation after verification complete

Risk Management Tools

Risk management tools (like Archer, LogicManager, or specialized medical device risk management systems) integrate with Catalio for risk-based requirements management:

Risk-Based Requirements Development:

Risk Management Integration Pattern:

1. Hazard Identification (Risk Management Tool):
   - Risk team identifies potential hazards through design review, FMEA, user studies
   - Hazards documented in risk management system with severity and probability
   - Risk level calculated (severity × probability)

2. Risk Control Identification (Risk Management Tool):
   - Risk team identifies risk control measures to mitigate high and medium risks
   - Risk controls documented with control type (design, procedural, information)
   - Each risk control references the hazard(s) it mitigates

3. Requirements Generation (Catalio):
   - Each risk control generates one or more requirements in Catalio
   - Requirements tagged with "Risk Control" and linked to hazard ID
   - Requirements document the specific control measure to be implemented
   - Requirements include acceptance criteria demonstrating control effectiveness

4. Traceability Maintenance:
   - Requirements in Catalio reference risk control IDs from risk management system
   - Risk controls in risk management system reference Catalio requirement IDs
   - Bidirectional traceability enables impact analysis

5. Risk Control Verification:
   - Requirements link to test cases verifying risk control implementation
   - Test results feed back to risk management system as verification evidence
   - Risk control effectiveness documented in risk management system

6. Residual Risk Evaluation (Risk Management Tool):
   - After risk control implementation and verification, residual risk evaluated
   - Residual risk documented in risk management system
   - Traceability from hazards through risk controls to requirements to verification maintained

Example:
Hazard H-045: Software Error Causes Incorrect Medication Dose Calculation
Risk Management System:
- Severity: Catastrophic
- Probability: Remote
- Risk Level: High
- Risk Control RC-045-A: Implement independent dose calculation verification
- Risk Control RC-045-B: Implement dose range checking against patient parameters

Catalio Requirements:
- REQ-SW-234: "System shall perform independent dose calculation using separate algorithm
  and compare results. If calculations differ by >1%, system shall alert clinician and
  prevent dose administration." [Links to RC-045-A]
- REQ-SW-235: "System shall validate calculated dose against patient weight, age, and renal
  function. If dose exceeds safe range, system shall alert clinician with warning message."
  [Links to RC-045-B]

Test Cases:
- TC-SW-234-01: Verify independent dose calculation with matching results
- TC-SW-234-02: Verify alert generation when calculations differ >1%
- TC-SW-234-03: Verify dose administration prevented when calculations differ
- TC-SW-235-01: Verify dose range validation against patient parameters
- TC-SW-235-02: Verify warning message when dose exceeds safe range

Risk Management System (Post-Verification):
- RC-045-A verified: Test results TC-SW-234-01 through TC-SW-234-03 pass
- RC-045-B verified: Test results TC-SW-235-01 through TC-SW-235-02 pass
- Residual Risk: Low (risk controls effective, verified through testing)

Integration Benefits:

• Risk-based approach ensures high-risk areas receive appropriate requirements coverage
• Requirements traceability to risk controls demonstrates risk mitigation
• Verification evidence from requirements testing supports residual risk evaluation
• Comprehensive documentation supports regulatory submissions (ISO 14971, IEC 62304)

Best Practices for Compliance

Organizations in regulated industries should follow these best practices when using Catalio for requirements management.

Requirement Writing for Validation

Requirements must be written to support validation activities:

Characteristics of Validatable Requirements:

Clear and Unambiguous: Requirements must be interpreted consistently by all readers:

• ❌ “The system should handle errors appropriately”
• ✅ “When database connection fails, the system shall display error message ‘Database unavailable. Please contact support.’ and log the error with timestamp and error details”

Testable: Requirements must include objective acceptance criteria that can be verified through testing:

• ❌ “The system shall be fast”
• ✅ “The system shall respond to user queries within 2 seconds for 95% of requests under normal load (≤100 concurrent users)”

Complete: Requirements must include all necessary information for implementation and testing:

• ❌ “The system shall encrypt data”
• ✅ “The system shall encrypt all personally identifiable information (PII) at rest using AES-256 encryption with keys managed by AWS KMS. Encryption shall be applied before data is written to the database and decryption shall occur after data retrieval.”

Consistent: Requirements must not contradict each other:

• ❌ REQ-001: “Session timeout shall be 5 minutes” vs. REQ-045: “User sessions remain active for 15 minutes”
• ✅ REQ-001: “Session timeout shall be 10 minutes of inactivity for standard users” and REQ-045: “Session timeout shall be 5 minutes of inactivity for administrative users”

Traceable: Requirements must be uniquely identified and linkable to other validation artifacts:

• ❌ Generic requirement description with no identifier
• ✅ “REQ-SW-123: [Clear requirement text]” with links to design specs, test cases, and risk controls

Verifiable: Requirements must specify how compliance will be demonstrated:

• ❌ “The system shall be secure”
• ✅ “The system shall enforce password complexity requirements (minimum 8 characters, uppercase, lowercase, number, special character). Verification: Attempt to set passwords not meeting criteria and confirm rejection with specific error messages.”

Review and Approval SOPs

Establish Standard Operating Procedures (SOPs) for requirements review and approval:

Review Process:

SOP: Requirements Review and Approval

Purpose:
Ensure requirements are complete, accurate, testable, and compliant with regulatory requirements
before approval and implementation.

Scope:
Applies to all requirements (user requirements, functional requirements, design specifications)
for systems subject to validation.

Roles and Responsibilities:
- Requirements Author: Creates requirements, incorporates review feedback
- Technical Reviewer: Reviews technical accuracy, completeness, feasibility
- Quality Reviewer: Reviews compliance with standards, validation approach
- Regulatory Reviewer: Reviews regulatory compliance, traceability to regulations
- Approver: Final approval authority (Project Manager, Quality Manager, or designee)

Review Process:

1. Requirements Authoring:
   - Author creates requirements in Catalio with status "Draft"
   - Author ensures each requirement includes description, acceptance criteria, regulatory rationale
   - Author links requirements to related requirements, risk controls, or regulations
   - Author assigns requirements for review

2. Technical Review:
   - Technical reviewer evaluates technical accuracy and feasibility
   - Technical reviewer verifies requirements are complete and implementable
   - Technical reviewer provides comments in Catalio or review meeting
   - Requirements status remains "Draft" during technical review

3. Quality Review:
   - Quality reviewer evaluates compliance with requirements standards
   - Quality reviewer verifies requirements are testable with clear acceptance criteria
   - Quality reviewer verifies validation approach is appropriate for risk level
   - Quality reviewer confirms requirements trace to applicable regulations/standards

4. Regulatory Review (if applicable):
   - Regulatory reviewer evaluates regulatory compliance
   - Regulatory reviewer verifies traceability to regulatory requirements
   - Regulatory reviewer confirms requirements support regulatory submission strategy

5. Comment Resolution:
   - Author addresses all review comments
   - Author updates requirements based on feedback
   - Author notifies reviewers of comment resolution
   - Reviewers verify comments are adequately addressed

6. Approval:
   - After all review comments resolved, requirements submitted for approval
   - Approver reviews requirements and review comment resolution
   - Approver changes requirement status to "Approved" in Catalio
   - Approval action recorded in Catalio audit trail

7. Baseline Management:
   - Approved requirements become part of requirements baseline
   - Requirements baseline documented with version number and approval date
   - Changes to approved requirements require change control process

Review Timeframes:
- Technical Review: 5 business days
- Quality Review: 3 business days
- Regulatory Review: 5 business days
- Comment Resolution: 3 business days per iteration
- Approval: 2 business days

Documentation:
- All review activities documented in Catalio
- Review comments captured in Catalio or meeting minutes
- Approval captured in Catalio audit trail
- Requirements baseline documented in project documentation

Managing Requirement Changes

Change control is critical in regulated environments:

Change Control Process:

SOP: Requirements Change Control

Purpose:
Ensure changes to approved requirements are evaluated for impact, appropriately authorized,
and implemented with full traceability.

Scope:
Applies to all changes to approved requirements for validated systems.

Change Categories:

1. Minor Changes:
   - Clarification of wording with no functional impact
   - Correction of typographical errors
   - Addition of traceability references
   - Impact: Documentation only
   - Approval: Technical Lead

2. Moderate Changes:
   - Changes to non-critical requirements affecting functionality but not safety or compliance
   - Addition of new non-critical requirements
   - Impact: Implementation and testing required
   - Approval: Project Manager + Quality Manager

3. Major Changes:
   - Changes to safety-critical requirements
   - Changes to requirements affecting regulatory compliance
   - Changes to requirements linked to risk controls
   - Impact: Significant implementation, testing, and documentation updates
   - Approval: Project Manager + Quality Manager + Regulatory Affairs

Change Process:

1. Change Request Initiation:
   - Requester identifies need for requirement change
   - Requester creates change request in change management system (ServiceNow)
   - Change request documents: current requirement, proposed change, rationale, urgency
   - Change request references Catalio requirement ID

2. Impact Assessment:
   - Change owner reviews requirement in Catalio
   - Change owner uses Catalio relationships to identify affected requirements, design specs, test cases
   - Change owner assesses implementation impact, testing impact, documentation impact
   - Change owner determines change category (minor, moderate, major)
   - Change owner documents impact assessment in change request

3. Change Approval:
   - Change request routed to appropriate approvers based on change category
   - Approvers review impact assessment and approve or reject change
   - Approval documented in change management system

4. Requirements Update:
   - After approval, author updates requirement in Catalio
   - Author documents change rationale in requirement description or change notes
   - Author updates related requirements, design specs, test cases as needed
   - Catalio audit trail captures change with timestamp and user identity
   - Author updates requirement version number if using version numbering

5. Impact Implementation:
   - Design specifications updated
   - Implementation changes completed
   - Test cases updated and executed
   - Documentation updated
   - All activities reference change request and updated requirements

6. Change Verification:
   - Verification testing confirms change implemented correctly
   - Regression testing confirms no unintended impacts
   - Test results documented with reference to change request

7. Change Closure:
   - Change owner verifies all impact activities completed
   - Change owner updates traceability in Catalio
   - Change request closed in change management system
   - Change documented in project change log

Emergency Changes:
In situations requiring immediate changes (production issues, safety concerns):
- Emergency approval obtained from Technical Manager + Quality Manager
- Change implemented with temporary documentation
- Full change control process completed within 48 hours
- Retroactive approvals and impact assessment documented
- Emergency change rationale documented

Prohibited Changes:
The following changes are not permitted:
- Changes that delete approved requirements without rationale and approval
- Changes that weaken safety or compliance controls
- Changes to audit trails or change history
- Changes without documented change requests (except minor clarifications)

Training and Competency Tracking

Personnel working with requirements must be trained:

Training Program Elements:

Initial Training: New personnel receive training before working with Catalio:

• Catalio system overview and navigation
• Requirements writing standards and best practices
• Review and approval processes
• Traceability and relationship management
• Change control procedures
• Regulatory requirements and compliance expectations
• Data integrity and audit trail importance

Role-Specific Training:

• Requirements Authors: Advanced training on requirements development, acceptance criteria, validation approaches
• Reviewers: Training on review standards, common issues, review documentation
• Approvers: Training on approval authorities, approval criteria, escalation procedures
• Administrators: Training on user management, security settings, backup procedures

Ongoing Training:

• Annual refresher training on requirements management processes
• Training on process updates or changes to SOPs
• Training on new Catalio features or capabilities
• Training on lessons learned from audits or inspections

Training Documentation:

• Training materials maintained in document management system
• Training records maintained for all personnel (date, topic, trainer, attendee signature)
• Training completion tracked before granting Catalio access
• Training records available for audit review

Competency Assessment:

• Periodic assessment of requirements quality (clarity, testability, completeness)
• Review of requirement traceability and relationships
• Evaluation of change control process compliance
• Feedback to individuals needing additional training or coaching

Audit Readiness

Maintaining continuous audit readiness is essential in regulated industries.

Documentation Completeness

Ensure all required documentation is complete and current:

Requirements Documentation Checklist:

• ✅ All requirements have unique identifiers
• ✅ All requirements include clear descriptions
• ✅ All requirements include testable acceptance criteria
• ✅ All requirements specify regulatory rationale (where applicable)
• ✅ All requirements have defined status (draft, review, approved)
• ✅ All requirements have appropriate categorization and tags
• ✅ All requirements link to related requirements (hierarchical and associative relationships)
• ✅ All requirements trace to validation artifacts (design specs, test cases)
• ✅ All requirements reference applicable regulations or standards
• ✅ All requirements have complete audit trails with change history

Supporting Documentation Checklist:

• ✅ Requirements Management Plan documenting approach, roles, tools, processes
• ✅ Requirements Standards defining requirements structure, format, acceptance criteria
• ✅ Requirements Traceability Matrices (RTM) showing forward and backward traceability
• ✅ Review and Approval Records documenting review activities and approvals
• ✅ Change Control Records documenting all requirement changes with impact assessment
• ✅ Validation Documentation referencing requirements (URS, FRS, Design Specs, Test Protocols)
• ✅ Risk Management Documentation linking risks, risk controls, and requirements
• ✅ Training Records documenting personnel training on requirements management

Completeness Verification:

Perform periodic documentation completeness audits:

Monthly Requirements Documentation Audit

Objective: Verify requirements documentation is complete and audit-ready

Audit Activities:
1. Select random sample of 20 requirements across all categories
2. Verify each requirement has all required elements (identifier, description, acceptance criteria)
3. Verify requirement relationships are documented (links to parent/child requirements)
4. Verify traceability to validation artifacts (test cases, design specs)
5. Verify audit trails are complete and accurate
6. Identify gaps or deficiencies
7. Create corrective action items for identified gaps
8. Track corrective action completion

Audit Report:
- Number of requirements sampled
- Number of complete requirements
- Number of requirements with gaps
- Description of identified gaps
- Corrective actions initiated
- Next audit date

Escalation:
- If >10% of sampled requirements have gaps, escalate to Quality Manager
- If critical requirements (safety, compliance) have gaps, escalate immediately

Traceability Demonstration

Auditors expect to see comprehensive traceability:

Traceability Matrix Preparation:

Generate Requirements Traceability Matrices (RTM) from Catalio:

Forward Traceability Matrix: Business Need → User Requirement → Functional Requirement → Design Specification → Implementation → Test Case → Test Result → Validation Evidence

Forward Traceability Matrix Example:

Business Need: BN-001: Enable secure remote patient monitoring
├─ User Requirement: URS-010: Patient Data Encryption
   ├─ Functional Requirement: FRS-045: AES-256 Encryption for Data at Rest
   │  ├─ Design Specification: DS-045: Database Encryption Implementation
   │  │  ├─ Implementation: Code Module: encryption_service.ex
   │  │  └─ Test Case: OQ-SEC-045-01: Verify Database Encryption
   │  │     └─ Test Result: OQ-SEC-045-01: PASS (executed 2024-08-15)
   │  │        └─ Validation Evidence: Encryption validated per test protocol OQ-SEC-045
   │  │
   │  └─ Test Case: OQ-SEC-045-02: Verify Encryption Key Management
   │     └─ Test Result: OQ-SEC-045-02: PASS (executed 2024-08-15)
   │
   └─ Functional Requirement: FRS-046: TLS 1.2+ for Data in Transit
      └─ Design Specification: DS-046: TLS Configuration
         └─ Test Case: OQ-SEC-046-01: Verify TLS Version and Cipher Suites
            └─ Test Result: OQ-SEC-046-01: PASS (executed 2024-08-16)

Backward Traceability Matrix: Validation Evidence → Test Result → Test Case → Implementation → Design Specification → Functional Requirement → User Requirement → Business Need

Requirements Coverage Matrix: Shows which requirements have complete traceability and which have gaps:

Requirements Coverage Analysis:

Total User Requirements: 45
Total Functional Requirements: 234

Coverage Metrics:
- Requirements with Design Specifications: 234/234 (100%)
- Requirements with Test Cases: 232/234 (99.1%)
- Requirements with Test Results: 230/234 (98.3%)
- Requirements with Validation Evidence: 228/234 (97.4%)

Requirements Without Test Cases:
- FRS-156: Help System Content Management (documentation requirement, no testing needed)
- FRS-198: User Interface Color Scheme (subjective requirement, verified through user acceptance)

Requirements Without Test Results:
- FRS-212: Annual Report Generation (OQ testing scheduled for 2024-09-15)
- FRS-223: Quarterly Compliance Report (OQ testing scheduled for 2024-09-20)

Gap Analysis:
- 2 requirements appropriately excluded from testing (documentation/subjective requirements)
- 4 requirements pending testing (testing scheduled within validation timeline)
- No gaps requiring corrective action

Conclusion: Requirements coverage is complete and on schedule for validation completion.

Traceability Demonstration During Audits:

When auditors request traceability demonstration:

1. Show Requirement: Display specific requirement in Catalio with full details
2. Show Relationships: Demonstrate relationships to parent requirements, child requirements, design specs, and test cases
3. Show Traceability Matrix: Present exported traceability matrix showing full trace from business need through validation
4. Show Audit Trail: Display complete change history for requirement with all changes documented
5. Show Evidence: Reference linked validation evidence (test results, validation reports)

Evidence Collection

Organize validation evidence for audit review:

Evidence Organization:

Validation Evidence Repository Structure:

/Validation_Evidence/
├─ /Requirements/
│  ├─ URS_UserRequirementsSpecification_v1.0.pdf
│  ├─ FRS_FunctionalRequirementsSpecification_v1.0.pdf
│  ├─ DS_DesignSpecification_v1.0.pdf
│  └─ RTM_RequirementsTraceabilityMatrix_v1.0.xlsx
│
├─ /Test_Protocols/
│  ├─ IQ_InstallationQualification_v1.0.pdf
│  ├─ OQ_OperationalQualification_v1.0.pdf
│  └─ PQ_PerformanceQualification_v1.0.pdf
│
├─ /Test_Results/
│  ├─ IQ_TestResults_2024-07-15.pdf
│  ├─ OQ_TestResults_2024-08-20.pdf
│  └─ PQ_TestResults_2024-09-10.pdf
│
├─ /Validation_Reports/
│  ├─ ValidationReport_v1.0.pdf
│  └─ ValidationSummary_v1.0.pdf
│
├─ /Change_Control/
│  ├─ ChangeRequest_CR-045.pdf
│  ├─ ChangeImpactAssessment_CR-045.pdf
│  └─ ChangeVerification_CR-045.pdf
│
├─ /Risk_Management/
│  ├─ RiskAssessment_v1.0.pdf
│  ├─ RiskControlMatrix_v1.0.xlsx
│  └─ ResidualRiskEvaluation_v1.0.pdf
│
└─ /Audit_Trail/
   ├─ Requirements_AuditTrail_Export_2024-10-01.pdf
   └─ Change_History_Summary_2024-10-01.pdf

Evidence Referencing:

Requirements in Catalio reference validation evidence:

Requirement: FRS-045: AES-256 Encryption for Data at Rest

Validation Evidence:
- Design Specification: DS-045 (Database Encryption Implementation), Section 4.3
- Test Protocol: OQ-SEC-045 (Operational Qualification - Security Testing)
- Test Case: OQ-SEC-045-01 (Verify Database Encryption)
- Test Results: OQ_TestResults_2024-08-20.pdf, pages 45-47, Result: PASS
- Validation Report: ValidationReport_v1.0.pdf, Section 5.2.1, page 89
- Code Review: Code review evidence documented in OQ_TestResults, Appendix D

Evidence Location: /Validation_Evidence/Test_Results/OQ_TestResults_2024-08-20.pdf

Verification Method: Testing
Verification Date: 2024-08-20
Verification Status: Complete - PASS
Validated: Yes

Evidence Availability:

Ensure evidence is organized and readily accessible:

• Evidence repository structured logically with clear naming conventions
• Index document listing all validation evidence with document numbers and locations
• Electronic evidence stored in validated document management system or secured folders
• Evidence access permissions configured for audit readiness (auditors can access read-only)
• Backup copies of evidence maintained per retention requirements

Inspection Preparation

Prepare for regulatory inspections systematically:

Pre-Inspection Preparation Activities:

30 Days Before Inspection:

• Review all requirements documentation for completeness and currency
• Verify traceability matrices are current and complete
• Review audit trails and change history for anomalies
• Conduct internal audit of requirements management process
• Address any gaps or deficiencies identified in internal audit
• Organize validation evidence repository
• Brief inspection team on inspection scope and likely focus areas

7 Days Before Inspection:

• Final review of all documentation
• Conduct dry-run inspection with mock inspectors
• Prepare inspection room with access to systems and documentation
• Configure read-only access for inspectors to Catalio (if remote access granted)
• Print key traceability matrices and summary documents
• Prepare presentation materials (system overview, validation summary, quality metrics)
• Brief personnel who will interact with inspectors

During Inspection:

Day 1 - Opening Meeting:

• Present system overview and validation summary
• Describe requirements management process and tools (Catalio)
• Provide traceability matrix and requirements documentation
• Discuss validation approach and acceptance criteria

Day 2-3 - Inspection Activities:

• Demonstrate Catalio system with live requirement examples
• Show requirement relationships and traceability
• Display audit trails and change history
• Walk through specific requirements selected by inspectors
• Present verification and validation evidence for sampled requirements
• Answer inspector questions with supporting documentation

Day 4 - Closing Meeting:

• Discuss inspector observations and findings
• Commit to corrective actions for identified deficiencies
• Request clarification on any unclear observations
• Thank inspectors for their time and professionalism

Post-Inspection Follow-Up:

If inspectors identify deficiencies:

FDA Form 483 Observation Response Example:

Observation: “The Requirements Traceability Matrix shows that Functional Requirement FRS-089 (User Session Timeout) does not have a corresponding test case documented in the Operational Qualification protocol.”

Company Response:

Immediate Action: Test Case OQ-SEC-023 tests user session timeout functionality per FRS-089. The traceability matrix had an incorrect reference linking FRS-089 to OQ-SEC-024 instead of OQ-SEC-023. The Requirements Traceability Matrix was corrected on [date] to reference the correct test case OQ-SEC-023. Updated traceability matrix attached.

Root Cause: The traceability error occurred during document generation when test case numbers were manually transcribed from Catalio to the traceability matrix spreadsheet. Manual transcription introduced a typographical error (023 → 024).

Corrective Action:

1. All traceability references in the RTM were verified against Catalio data
2. Automated RTM generation process implemented to eliminate manual transcription
3. RTM generation procedure updated to require cross-check verification
4. Traceability verification added to document review checklist

Preventive Action:

• Future RTMs will be generated directly from Catalio data export
• Monthly traceability audits implemented to identify discrepancies early
• Training provided to documentation team on traceability verification procedures

Evidence:

• Corrected Requirements Traceability Matrix (dated [date])
• Test Case OQ-SEC-023 demonstrating session timeout verification
• Updated RTM generation procedure (SOP-DOC-005, rev 1.1)
• Training records for documentation team (completed [date])

Completion Date: [date]

Signature: ******____****** Date: **__** [Name], Quality Assurance Manager

Conclusion

Requirements management in regulated industries is not just about documenting what a system should do—it’s about demonstrating compliance, ensuring patient safety, protecting customer data, and maintaining regulatory standing. Catalio provides the structured requirements management, comprehensive audit trails, and traceability capabilities that organizations in healthcare, finance, and pharmaceutical sectors need to meet their regulatory obligations.

By using Catalio as the foundation for requirements management, organizations can:

• Maintain Comprehensive Documentation: Complete requirements documentation with audit trails, version history, and traceability supporting FDA, HIPAA, SOX, GxP, and other regulatory requirements

• Demonstrate Compliance: Requirements traceability matrices and validation evidence demonstrate that regulatory requirements are addressed through system requirements and verified through testing

• Enable Change Control: Rigorous change management processes with impact assessment and traceability ensure that requirement changes are evaluated, authorized, and implemented with full documentation

• Support Audit Readiness: Organized requirements documentation with complete traceability and readily accessible validation evidence supports internal audits, external audits, and regulatory inspections

• Integrate with Quality Systems: Integration with change management systems, document management systems, quality management systems, and risk management tools provides comprehensive quality and compliance management

• Facilitate Regulatory Submissions: Requirements documentation generated from Catalio supports regulatory submissions including FDA 510(k), PMA, EU MDR technical documentation, and other regulatory filings

• Improve Product Quality: Well-managed requirements with comprehensive validation ensure that systems are designed, developed, and deployed to meet user needs and regulatory requirements

Whether you’re developing medical device software per IEC 62304, validating pharmaceutical systems per 21 CFR Part 11, implementing SOX controls for financial systems, or managing HIPAA compliance for healthcare platforms, Catalio provides the requirements management foundation you need for regulatory success.

For organizations in regulated industries, Catalio transforms requirements management from a compliance burden into a strategic advantage—enabling better products, faster validation, smoother audits, and regulatory confidence.