PIPA CONFERENCE
DATA INTEGRITY AND COMPUTER SYSTEM VALIDATION (CSV) By Emma Boulton
Trevor has 25 years’ experience in the pharmaceutical industry as an IT, CSV and Data Integrity specialist including 15 years in Quality Assurance for sponsors, service providers and as an independent consultant. Trev has taught on the MSc in Quality Management at Cranfield and teaches at the University of Hertfordshire on its MSc course in Pharmacovigilance. Trev is a Fellow of the Research Quality Association (FRQA) and is a tutor for Quality Risk Management and Data Integrity. He is currently the Chair of the RQA’s Digital Information Governance Information Technology (DIGIT) committee and Cross-GxP Data Integrity working party. Trevor’s 25 years of knowledge about this very niche topic was both engaging and enlightening. His presentation started with some key definitions and took us through the data integrity aspects of validation with a tie in with the General Data Protection Regulation (GDPR).
What is a computer system?
requirements for a specific intended use or application have been fulfilled.
It’s a set of hardware, software, procedures and people which together perform one or more data capture, processing, analysis and reporting functions, e.g. on regulatory study data.
Proving that the system is fit for purpose The presentation then moved on to the Good Automated Manufacturing Practice (GAMP) and the problems that can be encountered when deciding the GAMP software category that an application consists of into:
What is validation? The Food and Drug Administration (FDA) define validation as establishing documented evidence which provides a high degree of confidence that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
• Cat 1 – Infrastructure Software - Qualified installation (name, version), indirectly tested through use of application • Cat 3 – Non-Configured Software - Qualified installation (name, version), indirectly tested through use of application
ISO 9000 define it as confirmation by examination and through provision of objective evidence that the 6
