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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borghei/Claude-Skills☆ 9602026년 10월 7일 업데이트
Implement audit trail functionality for R projects in regulated environments. Covers logging, provenance tracking, electronic signatures, data integrity checks, and 21 CFR Part 11 compliance. Use when an R analysis requires electronic records compliance (21 CFR Part 11), when you need to track who did what and when in an analysis, when implementing data provenance tracking, or when creating tamper-evident analysis logs for regulatory submissions.
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pjt222/agent-almanac☆ 422026년 10월 21일 업데이트