GAMP to Issue Guide for Electronic Records, Signatures

The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), will release its "GAMP Good Practice Guide: Risk Management Approach to Electronic Records and Signatures," on Feb. 18 at an ISPE conference in Tampa, Fla.

"The guide is the culmination of more than a year's effort by the GAMP Europe and Americas steering committees," committee member Michael Wyrick said. "The document was developed by GAMP at the request of the FDA. The agency was seeking industry risk-based guidance approaches to support the scope and application changes advocated by the agency in its August 2003 21 CFR Part 11 guidance document."

The electronic records guide provides comprehensive guidance on meeting current regulatory 21 CFR Part 11 expectations for compliant electronic records and signatures, including requirements for record integrity, security and availability throughout the required retention period. "The guide documents how to meet these requirements through a combination of validated, well-documented systems, together with the application controls appropriate to the impact of the records concerned and the risks to those records," said Wyrick, senior director of validation and good manufacturing practices compliance services for Washington Group International in Indianapolis.

For more information about the ISPE conference, click here. (http://www.ispe.org/Template.cfm?%20Section=Course_Library1&Template=/courselibrary/ContAd/elecrecordsGAMP.cfm&ContentID=16358&CFID=1463206&CFTOKEN=73850664). For information about purchasing GAMP publications, click here (http://www.ispe.org/Template.cfm?Section=Publications).