Petch Ashida Druar

Syneos Health
Director, Computer Systems Quality and Data Integrity
Petch Ashida Druar is currently Director, Quality Assurance at Syneos Health. Her previous experience includes 20 years at GlaxoSmithKline (GSK), where she spent 10 years in the GSK R&D IT group, working primarily on computer systems validation projects supporting GCP and GLP business processes, before moving to R&D Computer Systems Quality Assurance (CSQA) in 2012. Petch received her BS degree in Electronic & Electrical Engineering from the University of Birmingham, UK, and MS and Engineer’s Degree in Engineering Economic Systems and Operations Research from Stanford University. She was a member of recently sunset ISPE GAMP Data Integrity Special Interest Group (SIG), where she contributed to the ISPE GAMP Records and Data Integrity Good Practice Guide: Data Integrity by Design. Petch is currently a member of the Computer Software Assurance SIG and Blockchain SIG.

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GAMP® Considerations When Relying on Open-Source Software
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GAMP® Considerations When Relying on Open-Source Software

This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS advanced since then, and the article explores the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP® 5...