A Risk-Based Approach to 21 CFR Part 11

Topics:
Commercial Banking,
Pharmeceuticals
Tags:
Compliance,
FDA,
Federal Government,
Government,
Guidance,
Tompkins Associates
Source:
Tompkins Associates

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Overview: On February 20, 2003, the federal Food and Drug Administration (FDA) announced major changes in the policy of enforcement concerning 21 CFR Part 11: Electronic Records, Electronic Signatures. The compliance policy guide concerning this regulation was immediately inactivated along with all previously published guidance documents. The new guidance poses no additional compliance risks and actually presents an opportunity to reduce costs and increase technological possibilities. The first step for pharmaceutical companies is to review internal documents, policies and procedures and make changes to reflect the new guidance. Current technology projects should be evaluated to determine if following the new guidance could reduce costs.

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Format: PDF | Size: 84KB | Date: May 2003 | Pages: 9

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