March 2013

ComplianceControl

Call us on: +44(0) 1606 871113 March 2013

Can Computer Systems Validation costs be reduced by 50%?

When the early versions of GAMP were published, the validation status of an automated machine, piece of equipment or software application was measured using a ruler! Folder upon folder of Documentation, many overflowing shelves, and many full cabinets, was not an unusual sight!

A ‘let’s document and test it all, just to be sure’ approach was taken it was better to be safe than sorry when faced with regulatory audits.

In my experience 4 of the key deliverables from Computer System Validation are:

1. Functional Specifications (system descriptions)
2. Test scripts and test specifications
3. User guides, Standard Operating Procedures (SOPs)
4. End user training material (including online e-learning)

Can the above be automated saving time and money and provide a significant saving for the industry?

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View a short video on this here http://bit.ly/11QC95u

Contact us here for a 10 minute online demonstration.

How to perform Computer System Validation on a Medical Device.

There are a range of standards with respect to Medical Devices such as ISO 13485, ISO 62304 and the ISPE GAMP guideline which is the pharmaceutical industry guideline for Computer System Validation. Whilst 13485 and 62304 don't really go into detail about how the software in a medical device can be validated, Bob Crawshaw explains how the GAMP guideline is a good place to start. 

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Have a wonderful Easter from
everyone at Compliance Control!

 

www.compliance-control.com

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Can AstraZeneca Job Cuts be another ‘Phoenix from the Ashes’?

There has been a lot of publicity recently regarding the decision by AZ to move R&D from the Alderley Park site in Cheshire, to a new facility in Cambridge, and questions are being asked about the current facilities at the site, and R&D staff that may not want to relocate?

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Science Park Road Shows.

Following Successful seminars in Oxford and Cambridge, we now move onto York, Newcastle, Scotland, Liverpool, Manchester and Nottingham!

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Meet the Team
Chris Farrar

Chris Small

Chris is part of the Product Design and Support team and is involved from all aspects from customer requirements through to final testing and release. 



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Customer References

  • I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project. CFO, Major Pharma Company
  • Compliance Controls Consultants brought immediate expertise to our team as part of our drive into the European market. Vice President, Research & Development, Pharma Company
  • We wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements. Business Development Manager, Phama Company
  • I would like to personally express my great appreciation for all your excellent work and great support with the validation of our IT infrastructure and software. Managing Director, Compounding Centre, UK
  • ComplianceControl Centre was selected because it is easy to use, quick to set up, and was a validated, cost effective solution for an organization of our size. We wanted a system that we could rapidly implement. Vice President, Research & Development, Pharma Company
  • Working with Compliance Control Consultants and their software products ComplianceControl Centre and cGARD helped us to understand the regulatory requirements of IT and business systems more clearly. IT Director, Pharma company
  • Using ComplianceControl Centre will help us to ensure that we are always inspection ready, by tracking our critical Quality and Compliance activities. Vice President, Research & Development, Pharma Company
  • It has been a pleasure working with you and your team and I am looking forward to co-operating with your company on similar projects in the future. Managing Director Compounding Centre UK
  • Based on your achievements and delivered results, we have started the process of building up our internal team for continuation of the work started by you. Managing Director, Pharma Company
  • cGARD has become the new rage here ! Sr. Manager, Documentation and Training, Major Pharma Company

 

 

    

 




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