paraqualis-gxp

Prepare for an FDA inspection of a computerized system against 21 CFR Part 11 (electronic records & signatures) — likely questions, evidence to assemble, and weak points

Generate a tailored 21 CFR Part 11 controls checklist for a computerized system, to drive validation or audit

Gap-assess a computerized system/process against 21 CFR Part 11, flagging compliance gaps with severity and remediation

Show the amendment history of a CFR part (any Title) — which sections changed and when — from the eCFR

Compare a CFR section/part between two dates (point-in-time) and show exactly what wording changed, from the eCFR

Installation Qualification (IQ) specialist. Use to examine a system's TECH STACK and installed/configured state and produce IQ evidence — or, in verify mode, to pre-check IQ items in an existing qualification pack against what's actually present. Delegated to by /qualify:build (generate) and /qualify:review (verify), typically in parallel with oq-qualifier and pq-qualifier.

Operational Qualification (OQ) specialist. Use to examine HOW a system has been built — its functions, configuration logic, build pipeline, and tests — and produce OQ evidence that it operates per specification; or, in verify mode, pre-check OQ items in an existing pack. Delegated to by /qualify:build (generate) and /qualify:review (verify), usually in parallel with iq-qualifier and pq-qualifier.

Performance Qualification (PQ) specialist. Use to verify a system DOES WHAT IT IS SUPPOSED TO in its intended use — requirements vs. actual behaviour, end-to-end workflows, representative data — and produce PQ evidence; or, in verify mode, pre-check PQ items in an existing pack. Delegated to by /qualify:build (generate) and /qualify:review (verify), usually in parallel with iq-qualifier and oq-qualifier.

Expert advisor on GAMP 5 (2nd ed.) risk-based computerized system validation (CSV). Use whenever the user asks about GAMP software categories (1/3/4/5), how to categorize a computerized or GxP system, how much validation rigor a system needs, IQ/OQ/PQ scope, URS/functional/design specifications, supplier/vendor assessment, configured vs. custom (bespoke) software, hybrid systems with custom scripts on a configured platform, or proportionate/risk-based CSV lifecycle deliverables for pharma/medtech systems. Also covers validation of AI/ML- and GenAI/LLM-enabled GxP systems (model validation, training-data integrity, drift monitoring, human oversight) per the ISPE GAMP Guide: Artificial Intelligence. Reasons against the bundled GAMP 5 category framework and AI/ML reference.

Expert advisor on FDA 21 CFR Part 11 (electronic records and electronic signatures). Use whenever the user asks about Part 11 compliance, electronic records or signatures, audit trails, closed vs. open systems, e-signature components/controls, record retention or copies for the agency, ALCOA+ data integrity under Part 11, a Part 11 gap or inspection readiness, or whether a computerized/GxP system meets §11.10, §11.30, §11.50, §11.70, §11.100, §11.200, or §11.300. Reasons against the bundled verbatim regulation text and cites the exact paragraph.

1 hook across 1 event