Context
Alpha-Stim's Essential Requirement Checklist needed the same treatment as any other country-specific checklist: verified directly against the current regulation, not carried forward from a generic template.
Quality Assurance • Regulatory Affairs
Regulatory Checklist & Work Instruction Update
Duration: 11 months • Role: Quality Assurance Specialist
Working through Alpha-Stim's quality and regulatory documentation showed that a country-specific checklist can't be adapted from a generic template without re-verifying every requirement against that country's actual regulation.
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- An outdated checklist or work instruction being followed after the underlying regulation or process has changed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.
Essential Requirements Checklist
QMS Procedures
Document Verification
Outcome
Updated the Essential Requirement Checklist to reflect the current country-specific regulation, closing the gap identified in the prior version.
Key Lessons
A country-specific checklist can't be adapted from a generic template without re-verifying every requirement against that country's actual regulation.
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