The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System Validation (CSV) approach that is being used by most companies in the Life Science Industry. Although not yet released, the proposed Computer Software Assurance for Manufacturing, Operations, and Quality System (CSA) guidance will assist manufacturers overcome several barriers to the efficient manufacture of drugs and medical devices. This will be accomplished through the use of implementing critical thinking early in the process, which will guide the verification process rather than using the industry’s current document-centric validation approach. The Computer Software Assurance guidance will provide manufacturers with the FDA’s point of view on the CSA process and will detail how industry can employ the process to verify a computerized system’s installation and operation. This white paper presents a short history of the FDA’s CSV guidance, how it became burdensome to projects, how the CSA approach compares to existing Agency guidance, and it presents steps that can be taken to implement the CSA approach to meet the goal of lowering the cost and duration of CSV efforts.
Assistant Director, CSV, CAI
Mr. Stephens is a knowledgeable computerized system validation manager with over 25 years of experience in validating equipment and systems, leading validation projects and teams, and developing lean CSV methodologies for companies and clients. He has utilized his CSV talents to successfully develop and implement CSV remediation programs in response to audits, warning letters and consent decrees, to manage the CSV project for new manufacturing suites and greenfield building constructions, and to manage the implementation of a global validation program.