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Computer Systems Validation
All computer systems and software impacting on product quality must be identified, and the risks in their use evaluated. From large-scale process control through to simple embedded code in a regulated device, pharmaceutical and medical device manufacturers are required to validate GxP-critical systems.
With over 29 years' experience in the design, build, implementation and validation of computer systems for major multinational organisations including AstraZeneca, Eli Lilly, GlaxoSmithKline, Piramal Healthcare and Sanofi, you can rely on the Industrial Technology Systems Ltd (ITS) team’s extensive knowledge in both the implementation and validation of software and computer system technologies.
Using GAMP® guidelines and industry best practices, including for example, 21 CFR Part 11, the rule for electronic records and signatures and data integrity, ITS has successfully completed over 280 validation projects since 1991.
Our knowledge and experience in the pharmaceutical, medical device, food and beverage, and nuclear fields allows us to identify opportunities, reject wasteful practices and unnecessary functionality, and avoid pitfalls during installation.
The value of a risk-based approach to computer, software and automated system validation cannot be underestimated. Whether it’s the need for computer system validation as part of a vital process automation project, the generation of a robust suite of operating procedures, assistance with the latest 21 CFR Part 11 requirements, a data integrity assessment or an audit of your existing systems and validation status, there is an ITS service to benefit your organisation.
Validated computer systems must be actively maintained in this state. Periodic reviews of operating issues, change control audits and comparisons with the evolving best practices are all essential to ensure continual compliance. ITS can also provide an ongoing integrated service to ensure that your computer system validation and compliance adds value and reduces regulatory risk.
ISPE owns the GAMP® trademark http://www.ispe.org/