GAMP Forum Issues Guide on Electronic Records and Signatures

The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), has released its "GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures."

The new guide supplements the "GAMP Guide for Validation of Automated Systems" and supersedes previous ISPE guidance, "Complying with 21 CFR Part 11, Electronic Records and Signatures," according to GAMP.

The guide was designed to help quality assurance and computer validation professionals, IT and IT compliance personnel, data owners and users, and systems developers, engineers, and suppliers comply with international guidelines for erecords and signatures. GAMP said the guide covers new and existing automated systems.

For more information about the new GAMP guide, click here (http://www.ispe.org/Template.cfm?Section=gamp_good_practice_guides&Template=/publications/ISPE_technical_guides/gamp_good_practice/ers.cfm).