2 skills · sorted by relevance
Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflows, and electronic signature compliance.
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Use this skill when the periodic policy review is due or overdue, or someone asks "run the annual policy review", "our policies are out of date", "re-approve the policies before the audit", "what changed since the last review", "policy version history" or "who needs to sign off which policy". Collects what changed since each policy was last approved (incidents, findings, exceptions, new systems, law), proposes the edits per policy, separates editorial from substantive changes, drafts the version history and approval record, and plans the communication to staff.
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