Context
Reviewing the RigidFix technical file template locally would have missed exactly the version-control gaps the file actually had. The review had to happen inside Qualio, against the controlled copy.
Regulatory Affairs • Technical Documentation
Technical File Strategy & Structure
Duration: 12 months • Role: Regulatory Affairs Specialist
Building the RigidFix technical file template showed that reviewing technical files inside the QMS platform (Qualio) surfaces version-control issues that a local-file review misses. The review has to happen where the controlled copy actually lives.
Primary Risks Identified
- A technical file with an outdated or misfiled document going unnoticed until a notified body review flags it
Testing Approach
Cross-referenced each technical file section against the applicable standard/GSPR table, verified document status directly in Qualio, and closed out pending or misfiled documents.
GSPR Table Cross-Referencing
Qualio Verification
Version Control Review
Outcome
Reviewed the technical files in Qualio, closing version-control gaps and confirming the controlled copies matched the current regulatory submission.
Key Lessons
Reviewing technical files inside the QMS platform (Qualio) surfaces version-control issues that a local-file review misses. The review has to happen where the controlled copy actually lives.
Have a system like this?
If you have no idea of testing your current system, let's talk through what's actually going on.
Contact me