Insights
Compounding, compliance & the FDA — in plain English
Practical guides for quality leaders and pharmacists-in-charge at 503B outsourcing facilities: electronic batch records, 21 CFR Part 11, USP<797>, and what inspectors actually look for.
Paper vs Electronic Batch Records: The 483 Risk Nobody Talks About
Transcription errors, missing signatures, and day-long audits: why paper batch records are the highest-risk part of a 503B compounding operation — and what FDA inspectors see.
2026-08-18 · 7 min read
21 CFR Part 11 for 503B Facilities: What the FDA Actually Checks
Audit trails, e-signatures, access controls, validation: a practical checklist of the five areas FDA inspectors focus on when they review your electronic records system.
2026-08-18 · 8 min read
Choosing a 503B eQMS: A Checklist for Quality Leaders
Electronic batch records, environmental monitoring, CAPA, validation: what to evaluate (and what to run from) when selecting a quality system for your outsourcing facility.
2026-08-18 · 9 min read
Want to see these controls in action?
Clarix is accepting a limited cohort of 503B facilities into its pilot program.
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