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

TERI STOKES | September 14, 2016

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“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.

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Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality's (AHRQ) mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. As 1 of 12 agencies within the Department of Health and Human Services, AHRQ supports research that helps people make more informed decisions and improves the quality of health care services. AHRQ was formerly known as the Agency for Health Care Policy and Research.

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Agency for Healthcare Research and Quality

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