Quality Assurance • Regulatory Affairs

Regulatory Code List & Reference Update

Duration: 1 month • Role: QA & Regulatory Specialist

Working through Clinical Oversight Forms for multiple products surfaced a reference code list (MDN, MDS, and similar codes) that had been carried forward version to version instead of rebuilt from the current authoritative source.

Context

Reviewing Clinical Oversight Forms across multiple products showed that the reference code list backing them had drifted from the current authoritative source. A code list is only trustworthy if it is rebuilt each time, not carried forward from the last version.

Quality Assurance Clinical Oversight Forms Reference Code Lists

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An outdated checklist or work instruction being followed after the underlying regulation or process has changed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.

QMS Procedures Checklist Review Regulatory Source Comparison

Outcome

Rebuilt the reference code list from the current authoritative source, correcting outdated entries.

Key Lessons

A reference code list (MDN, MDS, etc.) is only trustworthy if it's rebuilt from the current authoritative source each time, not carried forward from the last version.

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