Context
Reviewing the technical files in Qualio meant documenting the strategy behind the file structure itself, not just verifying the documents inside it.
Regulatory Affairs • Technical Documentation
Technical Documentation Review (Qualio)
Duration: 17 months • Role: Regulatory Affairs Specialist
A technical file strategy decision (what goes where, and why) has to be documented alongside the file itself, or the next person maintaining it repeats the same structural debate.
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- A technical file with an outdated or misfiled document going unnoticed until a notified body review flags it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
Outcome
Documented the technical file strategy, giving Regulatory a consistent structure to apply across product families.
Key Lessons
A technical file strategy decision (what goes where, and why) has to be documented alongside the file itself, or the next person maintaining it repeats the same structural debate.
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