Computer system validation (or CSV) services are targeted at lifesciences companies including pharmaceutical, bio-pharma and medical devices. All of these companies are regulated by so-called "GxP" rules and when computer systems are involved, a certain approach is needed to be able to prove compliance in a robust way.

A useful first step is an assessment of computer system validation maturity. This service compares an organisation's current level of maturity against industry best practices in order to decide on appropriate improvement plans. The validation landscape changes for a variety of reasons: regulatory authorities issue new regulations or guidance; ways of meeting regulations also change as best practices develop, often supported by technology advances. It is important to keep up to date with these changes not only to remain in compliance, but also in order to take advantage of new opportunities.

Specific areas of computer systems validation work include:
– Education & training of people responsible for implementation of computer systems
– Development of practical validation strategies taking a risk-based approach
– Coaching of project managers and others responsible for validation activities
– Assessment of project objectives and requirements and provision of a validation strategy

For further information about practical computer systems validation, please see the publications page.