Guide to Understanding FDA 21 CFR Part 11 Compliance

We can’t overstate the importance of FDA 21 CFR Part 11 compliance if you work in the pharmaceutical or medical device industry. Or, in fact, any manufacturing processes in any industry regulated by the FDA, from drug manufacture to biotech.
 
This regulation sets out the FDA’s criteria for ensuring electronic records and signatures are trustworthy, reliable, and on par with paper records. To comply successfully with the FDAs regulations, you need to understand their definitions and requirements to avoid misinterpretation. 
 
Download this guide to learn:
  • Key components of FDA 21 CFR Part 11 Compliance
  • Requirements to ensure you comply with these regulations
  • Implementation and maintenance of FDA 21 CFR Part 11 Compliance
  • Best practices for FDA 21 CFR Part 11 Compliance
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