Resource: Webinar – ADAMAS Computer Systems Compliance (CSC)

Presented by Matt Barthel – Head, Computer Systems Compliance & Data Protection Officer

At ADAMAS, we’re passionate about helping the businesses we serve with Computer Systems Compliance (CSC). But just what does that mean, and how has it changed over the years?

The objective of this session is to introduce key concepts associated with the assessment of Computer System Compliance, including:

  • Regulatory Requirements & Guidance
  • The SDLC
  • Validation Models
  • Applying Validation Principles to Legacy and existing Non-Validated Systems

Watch our latest Webinar to learn more.

Watch Webinar

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.

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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?

Identify whether your QMS is compliant to the upcoming ICH GCP Addendum

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.


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