Guides
Guides to the regulations and the work
Plain-English references to the rules FDA-regulated quality teams work under, and the quality work those rules create.
21 CFR Part 211: a plain-English guide to cGMP for finished pharmaceuticals
A plain-English guide to 21 CFR Part 211: what each subpart covers, the quality unit's authority, and the requirements quality teams spend the most time on.
October 6, 2026 · 3 min read02 / Regulations21 CFR Part 111: a plain-English guide to dietary supplement cGMP
A plain-English guide to 21 CFR Part 111: who it applies to, what each subpart covers, identity testing, CoA reliance, and record retention for supplements.
October 6, 2026 · 3 min read03 / Regulations21 CFR Part 11 checklist: electronic records and electronic signatures
A 21 CFR Part 11 checklist covering system controls, audit trails, signature manifestations, and electronic signature requirements for regulated systems.
October 6, 2026 · 3 min read04 / ValidationGAMP 5 and computer system validation: a practical guide
What GAMP 5 says about computer system validation: software categories, validation deliverables, the shift to computer software assurance, and AI systems.
October 6, 2026 · 3 min read05 / Quality basicsWhat is CAPA? Corrective and preventive action in GMP quality systems
What is CAPA in GMP quality systems? The difference between correction, corrective action, and preventive action, and how a defensible CAPA process works.
October 6, 2026 · 2 min read06 / Quality basicsCertificate of analysis (CoA): what it is and how to review one
What a certificate of analysis should include, when FDA lets you rely on one, and a step-by-step method for reviewing a CoA before material disposition.
October 6, 2026 · 2 min read07 / InspectionsFDA Form 483 and warning letters: what they mean and how to respond
The difference between an FDA Form 483 and a warning letter, what happens after an inspection, and how to write a response that prevents escalation.
October 6, 2026 · 2 min read08 / Industry analysisVeeva Falcon: capabilities, availability, and what it means for manufacturing quality
What Veeva Falcon is, how it differs from Vault AI, which Falcon offerings are available or planned, and what it means for manufacturing quality teams.
October 14, 2026 · 8 min read09 / AI in qualityWhat is agentic labor? What it means for quality teams
Agentic labor is AI carrying out a defined responsibility through multiple steps. What the term means for pharma quality teams, with a deviation example.
October 21, 2026 · 7 min read