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FDA 21 CFR Part 11 records, GMP documentation, cleanroom-adjacent storage, and lab-records compliance for biotech and pharma.
Featured field guide
A definitive HIPAA records compliance checklist for healthcare compliance and facilities leaders: the Security Rule controls that protect records (access, audit, integrity), how HIPAA, CMS, and Pennsylvania retention rules stack, the economics of a breach, defensible destruction, the ROT and dark-data problem, and a working audit-readiness checklist.
Read the guideA cited walkthrough of the ISO 14644-1 particle-count classification table, how ISO 5/7/8 map to EU GMP grades, and how to choose and build the right class for a life sciences facility.
A definitive reference for pharma and biotech QA, RA, and IT on document management under FDA 21 CFR Part 11 and GMP — covering the predicate rules, the electronic record and electronic signature controls in 11.10 through 11.300, ALCOA+ data integrity, computer system validation, audit trails, GxP retention periods, and the recurring failures behind FDA Form 483 observations and warning letters.
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