Data Integrity in Pharmaceutical Manufacturing - Technical Considerations. Posted on August 13, 2015 by Dr Joe Brady, Director for Global Compliance and Validation at Zenith Technologies Data and Record Integrity. 'GAMP® Good Practice Guide - A Risk Based Approach to Compliant The guide provides an overview of principles and practical guidance on meeting current expectations for the management of GxP regulated records and data. The International Society for Pharmaceutical Engineering (ISPE) has released their latest guidance document ISPE GAMP Guide: Records and Data Integrity. ISPE.org uses cookies to improve site functionality and to provide you with a better browsing experience. By using our site or clicking on "OK", you consent to the use of cookies. The GAMP Records and Data Integrity Guide provides timely and much needed direction on meeting current regulatory expectations for compliant electronic records and signatures. The Guide describes how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, through the application of 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 GAMP applies to Healthcare industries who produce pharmaceutical, biotechnology & medical devices fall under the embrace of the GAMP guidelines. The ISPE is an international organization, the GAMP documents are a guide to progress good manufacturing practices world wide. Because the GAMP guidelines are not a A new GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures has been developed by GAMP Forum, a technical subcommittee of ISPE, to provide timely and much needed guidance in this area. The ISPE GAMP® Guide: Records and Data In