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ISPE

FDA Compliance

ISPE Releases Guide on Electronic Records and Signatures Good Practices

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

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) 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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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.