Context
Writing the MDRiM work instruction meant reformatting and merging its source documents into the required structure before the instruction could be treated as submission-ready.
Quality Assurance • Regulatory Affairs
Work Instruction Development
Duration: 17 months • Role: Quality Assurance Specialist
Formatting and merging documents (fonts, structure) seems purely cosmetic but is often a submission requirement in its own right, getting it wrong is a preventable reason for rejection.
Primary Risks Identified
- An outdated checklist or work instruction being followed after the underlying regulation or process has changed
Testing Approach
Compared the existing checklist/instruction against the current regulation or process in practice, corrected discrepancies, and confirmed the update against the source document or QMS procedure.
Checklist Comparison
Work Instruction Verification
Outcome
Reformatted and merged the documents into the required standard, making the package submission-ready.
Key Lessons
Formatting and merging documents (fonts, structure) seems purely cosmetic but is often a submission requirement in its own right, getting it wrong is a preventable reason for rejection.
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