Impact before you change
See which designs, protocols, and risk items a requirement change touches — before the CR lands.
Solutions · Regulated industries
Audit-ready when the inspector walks in.
In healthcare, finance, and pharma, requirements aren’t paperwork — they’re how you prove patient safety, data integrity, and control. Catalio keeps validation evidence, change history, and bidirectional traceability inspection-ready.
Built for teams facing FDA · HIPAA · SOX · GxP expectations
Validation evidence · always current
Compliance fails when the matrix goes stale.
Overlapping regs, URS/FRS packages, change control, and immutable audit trails — traditional spreadsheets and wiki pages can’t keep up with continuous change.
URS→IQ
End-to-end validation chain in one map
Audit
Immutable change history with identity
Ready
Inspection readiness as a daily state
See requirements under configuration control
Status, ownership, linked evidence, and history — the same structure auditors expect to walk from business need to verified test.
Evidence that travels with work
Engineers and validators work from the same verified requirements your quality system can cite.
From URS to validated release — without the binder chase
Catalio structures the validation lifecycle so every artifact points back to a living requirement.
1
Specify
Capture user and functional requirements with acceptance criteria, risk links, and owners.
2
Control
Change history is automatic and immutable — who, what, when — ready for Part 11-style scrutiny.
3
Prove
Forward and backward traceability to design, tests, and validation status for every inspection.
Where regulated teams feel the difference
Healthcare devices, banking controls, and GxP systems share the same need: demonstrable truth.
Medical devices & HIPAA systems
Keep safety-critical requirements tied to risk, protocols, and verification — not a forgotten share drive.
Finance & pharma
SOX ITGCs and GxP data integrity expect ALCOA+ trails. Catalio makes the requirement layer audit-exportable.
Traditional compliance vs. Catalio
What inspection-ready validation looks like compared to binder-and-spreadsheet compliance.
| Category | Traditional | Catalio |
|---|---|---|
| Traceability matrix | Excel rebuilt before every audit | Living links from need → test → validation |
| Change control | Email + Word + SOP theater | Immutable history with identity and timestamp |
| Validation status | Scattered across QMS folders | Per-requirement status with supporting evidence |
| Access & segregation | Shared drives and group mailboxes | Org multi-tenancy + role-based access |
| Inspection day | Weeks of document archaeology | Walk the map; export the trail |
Advisory board
Guided by enterprise veterans who ran the systems we document.
Wayne Shurts
3× public-company CIO
Ex-CTO Sysco · Global CIO Cadbury · CIO Hall of Fame
Full bio
Wayne has 40 years helping food, retail, distribution, and consumer products companies transform their businesses worldwide. He most recently served as Executive Vice President and Chief Technology Officer at Sysco Corporation, the global leader in foodservice distribution, and was previously Chief Information Officer at SUPERVALU and Global CIO at Cadbury PLC, where he was based in the UK and led ERP and customer-facing programs across six continents. Wayne is currently an Independent Director at Armstrong World Industries (NYSE: AWI). He is a Boardroom Certified Qualified Technology Expert (QTE) and a 2017 inductee into the CIO Magazine Hall of Fame.
Jonathan C. Williams
Founder · CTO · advisor
Founded ForceIQ, acquired by Huron · West Monroe
Full bio
Jonathan has 25+ years building and scaling technology organizations across healthcare, financial services, energy, and SaaS. He founded and grew ForceIQ through its acquisition by Huron Consulting Group, and has served as CTO and strategic advisor to PE-backed and enterprise product companies at critical growth inflection points. His background spans platform modernization, engineering transformation, and responsible AI adoption, with a focus on how large organizations navigate complex technical change.
Wesley Story
Former CIO, Genesys
Ex-AWS, Sysco, Walmart · 2023 Orbie Global CIO of the Year
Full bio
Wesley has 30+ years building and scaling global technology organizations and leading enterprise-scale digital transformation. He most recently served as CIO at Genesys and enterprise strategist at Amazon Web Services, with prior senior technology leadership roles at Sysco and Walmart, spanning retail, wholesale distribution, hyperscaler cloud, SaaS, and telecom. His work spans cloud and platform modernization, responsible AI/ML and data adoption, and post-M&A integration across global, matrixed environments. Wesley was named a 2023 Orbie Global CIO of the Year.
Be inspection-ready every day — not every scramble.
Stop rebuilding matrices. Keep the validation chain current as the system changes.
FAQ
Questions compliance leaders ask
Does Catalio replace our QMS / eQMS?
No. Catalio is the living requirements and traceability layer that feeds validation packages and audits — integrate with your quality system of record.
Do you support electronic signatures (Part 11)?
Approval actions are captured in immutable audit trails today; native e-sign is on the roadmap. Many teams integrate DocuSign/Adobe Sign for formal manifestation while Catalio holds the content.
Can we reconstruct requirements as of a past validation?
Yes — change history and status let you reconstruct what was approved, when, and by whom, instead of hunting folder snapshots.
Ready to make validation evidence continuous?
Book a demo focused on one regulated system and walk the traceability chain together.
Book a demoGet started
Ready to finally understand your systems?
A working session on one of your systems: connect it, watch the extraction, and read the first requirements together. 30 minutes.
- → First application documented in days, not months
- → Encryption · RBAC · SSO via SAML 2.0 / OAuth 2.0 · audit logs
- → Our team connects your first platform with you