Regulatory Affairs • Technical Documentation

Technical Documentation - RigidFix Technical File

Published • • 2 min read

Creating the technical documentation of RigidFix based on GII 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.

Creating RigidFix's technical documentation based on GII, with pending documents still needing correlation, meant building the file's structure once rather than treating each pending document as a one-off addition.

Build once, maintain forever

A technical file structure built fresh for every pending document correlation wastes time re-deriving what the table of contents and cross-references should already reflect. Building it once and maintaining it is the faster path every time after the first.

Creating the documentation required:
  • Cross-referencing each technical file section against the applicable standard/GSPR table
  • Verifying document status directly in Qualio
  • Closing out pending or misfiled documents

What an outdated document risks

A technical file with an outdated or misfiled document going unnoticed until a notified body review flags it is exactly what a maintained structure, rather than a rebuilt one, is designed to prevent.

What the structure delivered

Building out the technical file template/structure for RigidFix, correlating pending documents against the applicable general safety and performance requirements, gave the file a structure that could be maintained going forward.

The Real Takeaway

A technical file only stays audit-ready if its structure is built once and then maintained.

Rebuilding the structure per submission wastes far more time than maintaining it.

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