Context
RigidFix's technical file needed a structure built once, correlated against the applicable general safety and performance requirements, and maintained going forward rather than rebuilt at the next submission.
Regulatory Affairs • Technical Documentation
Technical Documentation - RigidFix Technical File
Duration: 11 months • Role: Regulatory Affairs Specialist
Building out RigidFix's technical file template showed that a technical file only stays audit-ready if its structure (table of contents, cross-references between sections) is built once and then maintained. Rebuilding the structure per submission wastes far more time than maintaining it.
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- A technical file with an outdated or misfiled document going unnoticed until a notified body review flags it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
Technical File Template
Outcome
Built out the technical file template/structure for RigidFix, correlating pending documents against the applicable general safety and performance requirements.
Key Lessons
A technical file only stays audit-ready if its structure (table of contents, cross-references between sections) is built once and then maintained. Rebuilding the structure per submission wastes far more time than maintaining it.
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