Computer System Validation Audits
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
Watch More Adamas VideosComputerised 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
“As always, it was a very interesting and enriching experience auditing with you; I really enjoyed our collaboration.“H.B., CQA Manager, Global Pharma
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