Are You Ready? FDA's Transition From Computer System Validation To Computer Software Assurance
By Kathleen Warner, Ph.D., RCM Technologies
The FDA regulation 21 CFR Part 11 in 1997 and the related guidance of 2003 paved the road to implementation of computer system validation (CSV) by life sciences companies.
As pharmaceutical companies perfected their business processes and became more efficient in validating computer systems, the piles of documentation continued to grow without significant quality benefits. The focus was on speed, documentation accuracy and completeness, inspections, audits, and complying with the regulation.
In 2011 the Center for Devices and Radiological Health (CDRH) initiated the Case for Quality, a new program that identified barriers in the current validation of software in medical devices guidance (released in 2002). Now, CDRH — in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) — is preparing to release new guidance, Computer Software Assurance for Manufacturing, Operations and Quality Systems Software, in late 2020...
