FDA Premarket Approval (PMA) and 510(k) reviews scrutinize the connection between clinical claims, software requirements, risk mitigations, and verification test outputs. This guide outlines database-driven traceability frameworks that automatically compile audit-ready documentation.
Manual spreadsheet traceability leads to audit discrepancies and regulatory review pauses. Semantic graph databases linking requirements, git commits, and test outputs eliminate documentation lag.
CI/CD pipelines automatically bundle test execution logs, static analysis reports, and code review signatures into electronic submissions complying with 21 CFR Part 11.