Context
Without a written record of why the technical file was structured the way it was, every new person maintaining it would re-argue the same layout decisions. Documenting the strategy alongside the file itself closed that gap.
Regulatory Affairs • Technical Documentation
Technical Documentation Review (Qualio)
Duration: 11 months • Role: Regulatory Affairs Specialist
Documenting the technical file strategy showed that a strategy decision (what goes where, and why) has to be recorded 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- A technical file with an outdated or misfiled document going unnoticed until a notified body review flags it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
Strategy Documentation
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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