Regulatory Compliance Standards

Regulatory Compliance Standards (UK :MHRA, US :FDA, ICH Q8,9,10) state that any Life Science, Biotech, Pharmaceutical or similar regulated company, must conform to industry guidelines including Good Manufacturing Practice (GMP) and that they must have a Documented Quality Management System and associated processes and controls. Whilst this has traditionally been carried out via paper based systems increasing pressure is now on these organisations to automate these processes and systems and use Electronic Quality Management Software.

In using Electronic Quality Management Software systems as part of this process, USA  21 CFR Part 11 and EU GMP Annex 11, covering Electronic Records and Electronic Signatures must be adhered to, and as of 30th June 2012, Eudralex Volume 4, Annex 11 was updated to state that Infrastructure must be Qualified as well as Computer Systems must be Validated.



     
     

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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