Resource: Infographic –

21CFR11 Compliance of Third-Party Computer Systems

Many system and software vendors claim that they offer “turnkey” or ready-made 21CFR11-compliant systems.

This is their way of enticing potential customers towards the purchase of a (usually) expensive product, knowing full well that this will be at the top of their “wish list”.

However, due to the nature of the regulation itself, ready-made compliance simply cannot be delivered by vendors/suppliers.

Download our infographic to discover why – and how you can protect yourself from regulatory issues, reputational damage and fines.

Download Infographic

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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Get going and start reducing risk today. Pre register now.

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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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