INFORMATION TECHNOLOGY
How Risk-based Approaches to Computer System Validation Support Cost-Effective Compliance and Improved Patient Safety Computerised digital information and document handling systems are at the heart of almost all life science and pharmaceutical industry operations. From the earliest phases of development to the last post-approval study, the data and technical documentation these systems manage are essential to the safe, effective creation of medicines and therapeutics for patients. Every passing year the life sciences industry’s approach to continuous improvement has seen the increasing application of computerised systems to deliver better results, ranging from lower-cost manufacturing and faster development timelines to breakthrough drugs and better patient health outcomes. But the industry’s increasing dependence on computer-based digital systems is not without its own capital investment and operational expense, and that includes the cost of computer system validation (CSV) and compliance. Brendan Walshe, CSV Consultant, Zenith Technologies, a Cognizant Company
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P H A RM A F O C U S A S I A
ISSUE 45 - 2021
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t the heart of almost all life science and pharmaceutical industry operations are digital information and document handling systems. From the earliest clinical phases to the last post-approval study, the data and technical documentation these systems manage are essential to the safe, effective creation of medicines and therapeutics for all patients. Every passing year, the life sciences industry’s approach to continuous improvement has seen the increasing application of computerised systems to deliver better results. Pharmaceutical Manufacturing’s fifth annual Smart Pharma survey found just over 88% of pharma manufacturers believe their company will choose to automate processes if given the option and approximately 90% of those responding had begun their digital transformation efforts1. It is a competitive imperative 1 https://www.pharmamanufacturing.com/articles/2021/ smart-pharma-survey-results-pharmas-digital-prowessput-to-the/
