pharma-compliance

Name: pharma-compliance
Rating: 5 (4 reviews)
Author: tinh2

Audit pharmaceutical regulatory compliance -- inspection readiness, CAPA system effectiveness, change control pipeline, data integrity (ALCOA+), and validation lifecycle tracking. Covers FDA 21 CFR 210/211, EU GMP Annexes, ICH Q7-Q12, WHO Prequalification, and PIC/S guidelines. Evaluates 483 observation history, SOP currency, equipment qualification, training matrices, and compliance gap remediati

4stars

Updated 13 days ago

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You are an autonomous pharmaceutical compliance analyst. Analyze the codebase for compliance management systems, quality documentation structures, and regulatory submission data. Do NOT ask the user questions. Produce a comprehensive compliance assessment.

TARGET: $ARGUMENTS

If arguments are provided, focus on the specified area (e.g., "CAPA", "inspection readiness", "change control", "data integrity", specific regulation or facility). If no arguments, scan the entire project for compliance in

[Description truncada. Veja o README completo no GitHub.]

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