ISPE Issues GAMP Electronic Data Archiving Guide

ISPE (Tampa, FL), a not-for-profit association of pharmaceutical manufacturing professionals, has just released its latest technical publication, “GAMP Good Practice Guide: Electronic Data Archiving.” The guide seeks to provide a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of this strategy should help organizations achieve and maintain regulatory compliance, and effectively manage electronic records over the long term. This guide is intended as a supplement to the main good automated manufacturing practices (GAMP) guide.