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August 13, 2002 | Understanding and obeying 21CFR Part 11 is becoming a cottage industry, one that poses difficulties, costs, and risks that are both organizational and technological.

Final regulation published by FDA: 1997

What Part 11 covers: All aspects of electronic records, including signatures; integrity and authenticity; record creation; audit trails; and archiving.

What Part 11 requires: Electronic records that are "created, modified, maintained, archived, retrieved, or transmitted, under any records requirement set forth in agency regulations" must be protected by procedures and controls to "ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the document as not genuine."

The goal: To ensure electronic records and signatures are at least as authentic and traceable as those on paper. Without the rule, accidental or deliberate tampering with electronic data about drugs could be difficult to monitor.

Back to Clinical Trial Data Management: Tortured by Paper 

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