The Impact of the Guidance for Industry Part 11, Electronic Records, Electronic Signatures – Scope and Application
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White Paper
ABSTRACT
This document will interpret and discuss the impact of the Guidance for Industry – Part 11, Electronic Records, Electronic Signatures – Scope and Application which was released as a final guidance for industry by the FDA in August of 2003. As part of its new risk management/quality systems based cGMP initiative, the Agency will re-examine the Part 11 regulation. This effort will likely include revisions to the regulation to bring it up to date and inline with the new Agency philosophy. While this re-examination is taking place, the Agency will implement a narrower interpretation of the scope of 21 CFR Part 11, as detailed in the new guidance document. Although the guidance narrows the scope of Part 11 and gives latitude in the implementation of certain controls, regulated organizations must still comply with 21 CFR Part 11 and all applicable predicate rules.
Robert J. Finamore
Sr. Validation Manager
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