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Quality Digest

FDA Compliance

ISPE Releases Guide on Electronic Records and Signatures Good Practices

Published: Tuesday, April 26, 2005 - 22:00

The International Society for Pharmaceutical Engineering announced the availability of its newest technical publication, “GAMP Good Practices Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.” The guide is a user-friendly manual that covers the appropriate management of electronic records and signatures. It’s the newest edition to ISPE’s GAMP Good Practice Guide Series, developed by the GAMP Forum, a technical subcommittee of ISPE. It supplements the existing “Good Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture—GAMP 4.”

The main section of the guide provides a process by which a regulated company can identify the hazards associated with the use of electronic records and signatures, analyze and evaluate risks, control risks, and monitor the effectiveness of the controls via periodic review.

For more information, visit www.ispe.org.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.