Computer System Compliance
ADAMAS provides a comprehensive CSC service in all stages of the life cycle of a computerised system whether it’s being used in clinical development, drug safety, a laboratory or manufacturing facility. We can help you identify any compliance gaps in your systems and procedures, as well as provide advice on remedial actions.
Assess validation status of client’s or vendor’s IT system
Identify gaps in the validation status
Advice on how to bring systems into compliance
Find out how ADAMAS Consulting can help with your next project
Recent examples of our work:
Consulting advice on software life-cycle for GCP computerised systems.
Audit of service provider maintaining a medical information system.
CSV audit of biometrics randomisation system.
ADAMAS’s approach to CSC is to provide a positive and pragmatic service which is of optimum benefit to the auditee.
- Computer System Validation (CSV) Audits (specific system/software or group of systems)
- CSV Vendor Audits (computer systems supplied by third parties e.g. eCRFs, eTMFs, IRT)
- Process Audits (SDLC or parts of SDLC and IT support processes)
- SDLC Design and Implementation
- Gap Analyses vs key CSC requirements e.g. 21CFR11
- CSV Documentation Reviews
- Ad Hoc advice on CSV strategies and requirements
Thank you for performing a thorough audit. I wanted you to know that I was impressed by your professionalism and audit approach. I like that you presented the observations in an unbiased ‘matter of fact’ way. The slides were also exceptionally helpful in understanding the issues identified. It is really a pleasure working with you both and I’m looking forward to future business with you.T.R.
If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.