Source: http://www.mastercontrol.com/newsletter/feature/fda_21_cfr_part_11_107.html
Timestamp: 2016-02-11 12:47:15
Document Index: 752445042

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Blog GxP Lifeline Feature Article
By David Ade Understanding Predicate Rules Found in GxP, GLP, GCP, CGMP, Key to Compliance with FDA 21 CFR Part 11	Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.
Although predicate rules were originally meant to apply to paper records (which required handwritten signatures), these rules remain applicable even when you use electronic records and signatures. In this case, 21 CFR 11 then becomes an additional requirement for e-records and signatures. Part 11 requirements are not meant to replace or override other FDA (GxP, GLP, GCP, CGMP) regulations pertaining to signatures and records. Sample Predicate Rules
David Ade, a product manager at MasterControl Inc., specializes on FDA computer validation and other software-related requirements. Learn More About 21 CFR Part 11 White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection? White Paper: 21 CFR Part 11 - Risk of Non-compliance White Paper: 5 Ways to Ensure System Compliance with 21 CFR Part 11 Click here to view all available resources.
2003 Part 11 Guidance Full Article Additional Articles
Part 11 Provides Little Guidance Full Article FDA and 21 CFR Part 11
Full Article Interview with FDA Director Full Article Easing the Pain Full Article Part 11 Enforcement Full Article Get Social