Creating a Computer System Validation Strategy
In a highly regulated industry, a Computer System Validation strategy is an essential part of your business
Overview
Are you working in a highly regulated environment that requires your company to demonstrate that your infrastructure, computer systems and software do exactly what they are designed to do, in a consistent and accurate manner? Computer System Validation (CSV) helps you to ensure the consistency, quality and accuracy of your infrastructure, computer systems and software.
Why your business needs a Computer System Validation Strategy
Being able to stand over the performance of your systems and software can be challenging unless you have put in place a clear strategy to support your CSV activity and meet your regulatory compliance obligations. Having a CSV strategy simply means knowing what you want to achieve and putting a plan in place to get you there.
The Odyssey VC Regulatory & Quality Framework provides your organisation with the guidance and tools it needs to build and execute a plan of action to achieve your computer system validation objectives. Our expertise will help you to develop a strategy that addresses regulations such as FDA 21 CFR Part 11, EMA Annex 11 and GAMP (GxP for applications).
