Computer System Validation

In clinical research and development, IT systems, whether they are for clinical development, drug safety, the laboratory or manufacturing facility, need to be validated according to international regulations and guidelines. Adamas can:

Review the validation status of your IT systems
Review the validation status of vendor IT systems
Identify any gaps in the IT system validation status
Advise on how best to bring your systems into compliance

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Computerised System Validation Audits

ADAMAS Consulting provides a comprehensive Computer Systems Validation (CSV) audit service in all stages of the life cycle of a computerised system. The objective of the CSV audit is to assess good computer system management practice, and to verify that the computerised system is validated according to regulatory requirements such as 21 CFR part 11. ADAMAS Consulting's approach to CSV audits is to provide a positive and pragmatic service which is of optimum benefit to the auditee. A CSV audit involves:

A review of all procedures
A review of software development documentation
A review of operational documentation
Assessment of computer room hardware
A review of network design and management

Contact us to see how we could help you

Contact ADAMAS Consulting by email or
on +44 (0)1344 751 210 to discuss your individual requirements.

“Just to repeat what I have already said to your Consultant. The report was the most professional and well written report that I have come across in many years of involvement in Clinical Research.”
C.P., Director Project Management, International CRO

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