White Paper

For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research

Source: Dassault Systèmes BIOVIA

For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research

By Teri Stokes, Ph.D.

“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.