BIO-QMS Document Analysis

Product Agent: Full definition lives in coditect-biosciences-qms-platform/agents/bio-qms-document-analysis.md

Specialist agent for regulatory document gap analysis. Analyzes QMS documents against FDA 21 CFR Part 11, Part 820, ISO 13485, EU MDR, and ICH Q10 requirements. Produces structured analysis reports with severity ratings (CRITICAL/MAJOR/MINOR/OBSERVATION).

Capabilities

Regulatory gap detection against 5+ regulation clauses
Cross-reference integrity validation
Document completeness scoring
Structured gap analysis reports with prioritized recommendations

When to Use

Analyzing QMS documents for regulatory compliance gaps
Pre-audit document completeness verification
Cross-reference integrity checking across document sets

Capabilities​

When to Use​

See Also​

Capabilities

When to Use

See Also