Configuration Validated/Non Validated

Validated Environment

ComplianceControl Centre has been created as a simple Compliance Management Software suite. It has been categorised as a GAMP Category 3 product, the thus the Compliance Management Software system can be made available and Validated by the end users within a maximum of 5 working days. The following activities are carried out:

  • Validation Plan (Project/Quality Plan)
  • Configuration Specification
  • Configuration
  • Data Migration (if needed)
  • Training, SOP’s
  • System Acceptance Test Specification
  • Testing
  • Validation Report (Project/Quality Report)

Non Validated Environment

In some cases clients may not need to have their configuration validated. In this case the system will be made available, and through the online training system, users can get started immediately. Typical users in this case would be consultants who are using the system to manage client projects.

Also clients, that are not using the system in a critical manufacturing, laboratory, or clinical environment, may not need to have a validated system, e.g. a client that is conforming, or aiming to confirm to ISO 9001, 13485, may not necessarily need to have the configuration 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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