Adamas Consulting Brochure
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Contact Us
Europe - Tel: +44 (0)1344 751 210
US and Canada -Tel: +1 919 294 4162

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

 

“Thanks for your kind words and I just wanted to reiterate my conclusion : we appreciated the way you managed this audit : with respect to both the staff and their work ,allowing us to manage both day to day activities and the audit . In addition we all appreciated you flexibility for the Thursday meeting. I will not hesitate to call you when necessary.”
D.D., Director of Pharmacovigilance Europe , Global Pharma