FDA 21 CFR Part 11

1. TERM HEADER FDA 21 CFR Part 11 Domain Tags: [Manufacturing] [Compliance] [Standards & Compliance] 2. CONCISE DEFINITION FDA 21 CFR Part 11 is the US Food and Drug Administration regulation that governs electronic records and electronic signatures, defining when they are trustworthy and equivalent to paper for regulated manufacturing. 3. EXPANDED DEFINITION Part 11 sets requirements for electronic records used in FDA-regulated industries: they must be accurate, protected, attributable, and auditable, with controlled electronic signatures. It makes paperless production possible only when the system enforces integrity and a complete audit trail. 4. WHY IT MATTERS Regulated manufacturers must prove their electronic records can be trusted. Systems that lack a secure, tamper-evident audit trail cannot meet Part 11, forcing costly paper processes. 5. HOW MONITORZ SUPPORTS PART 11 READINESS MonitorZ captures production activity as attributable, time-stamped electronic records. [Real-time production tracking](/shop-floor-data-collection) records each action as it happens, and the [OPC-UA Data Pipeline](/opc-ua-data-pipeline) captures machine data directly, building the audit trail regulated records require. Deployments have raised production up to **133% within 120 days** across **500+ implementations**. Explore the [Solutions overview](/solutions). 6. FREQUENTLY ASKED QUESTIONS (FAQ) Q: What is FDA 21 CFR Part 11? A: It is the FDA regulation governing electronic records and signatures, defining when they are trustworthy and equivalent to paper in regulated manufacturing. Q: How does MonitorZ help with 21 CFR Part 11? A: MonitorZ records production as attributable, time-stamped electronic data with an audit trail, supporting the record integrity the regulation requires. 11. RELATED TERMS AND CONCEPTS ISO 13485, ISO 9001, Traceability, Real-time Production Tracking.