Far too many firms fail to even grasp what compliance would require. There are integrated systems that are fully-FDA CFR 21 Part 11 compliant that do not come with the high price tag, especially for a mid-sized firm.
 

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Home > Resources > White Papers > Pharmaceutical Processing: Lots More Than Tracking!

Pharmaceutical Processing: Lots More Than Tracking! What FDA CFR 21 Part 11 Is and Is Not

Think that because you have strong controls for lot tracking and traceability you are fully compliant with FDA CFR 21 Part 11? Think again! The truth is, lot tracking is more tangential to what FDA CFR Part 11 is all about, and far from being the pith of the matter. Yes, you must address lot tracking to be FDA-compliant, because lot tracking with integrity is an essential part of FDA-mandated GMPs (Good Manufacturing Practices). But lot tracking and other ingredients of product accountability are NOT what FDA CFR Part 11 is about. Rather, Part 11 addresses the closely related but separate matter of your data accountability.

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