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CFR Part 11 Compliance The Cognizant Approach Cognizant Technology Solutions 500 Gunpoint Center West, Tea neck, NJ 07666 http://www.cognizant.com 21 CFR Part 11 Compliance- The Cognizant Approach

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What is 21 cfr part 11?

21 CFR Part 11 is a set of regulations established by the U.S. Food and Drug Administration (FDA) that governs the use of electronic records and electronic signatures in the pharmaceutical, biotechnology, and related industries.

Who is required to file 21 cfr part 11?

Any organization that uses electronic records and signatures in their regulated activities associated with the FDA is required to comply with 21 CFR Part 11.

How to fill out 21 cfr part 11?

To comply with 21 CFR Part 11, organizations must establish controls for electronic records and signatures, including system validation, access controls, audit trails, and training for users on compliance policies.

What is the purpose of 21 cfr part 11?

The purpose of 21 CFR Part 11 is to ensure that electronic records and signatures are trustworthy, reliable, and equivalent to paper records while allowing for the use of technology in regulated environments.

What information must be reported on 21 cfr part 11?

Organizations must report information relevant to electronic records management and electronic signatures, including any system validation procedures, security protocols, access controls, and any instances of data integrity issues.