This edition of the Proxima Weekly Briefing explores Title 21, Part 11 of the Code of Federal Regulations, also known as 21 CFR Part 11. Associate Director of Regulatory Affairs, Ellie Reynolds, provides the guidance that developers will need to maintain compliance with Part 11, which regulates the requirements for those who choose to maintain records or submit information electronically!
Want to learn more? Get briefed with our other resources related to this topic!
Read: 21 CFR Part 11
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Read: Code of Federal Regulations (CFR)
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Watch: Paper Based vs. Electronic QMS
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Proxima works with emerging biotech and medical device companies across all phases of development.
As a contract research organization, we organize our team in two distinct areas: early-stage advisory consulting and all-inclusive clinical trial services. The service you need. The speed you want. The attention you deserve.
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