Computer System Validation Audits

ADAMAS provides a comprehensive CSV audit 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.

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Assess validation status of client’s or vendor’s IT system

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Identify gaps in the validation status

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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 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

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.

Clinical QA Manager, Global Pharma Company

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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.

Contact Adamas
The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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