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The Code of Federal Regulations Title 21, Part 11 applies across a range of regulated industries including pharmaceuticals, biologics, medical devices and food products (human and veterinary). Companies in these segments doing business in the U.S., providers of raw materials and components to pharmaceutical companies and contract labs commissioned to perform analysis work must all operate to ensure electronic records and electronic signatures are trustworthy and reliable.
Optimizing Quality Control Electronic Records for 21 CFR Part 11 Compliance
In this video, Beckman Coulter Product Manager Tony Harrison covers quality control records and 21 CFR Part 11, manual and electronic SOPs, final product QC, cleanroom environmental monitoring records and QC instrumentation electronic records.