Context
A second technical file strategy review confirmed the same principle as the earlier one: the controlled copy in Qualio, not a local export, is where version-control problems actually show up.
Regulatory Affairs • Technical Documentation
Technical File Strategy & Structure
Duration: 9 months • Role: Regulatory Affairs Specialist
A follow-up technical file strategy review showed once more 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- A technical file with an outdated or misfiled document going unnoticed until a notified body review flags it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.
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