Validation

In the pharmaceutical, medical device, and other similar industries such as food, blood, tissue and clinical trials, validation is the documented act of demonstrating that a procedure, process, and activity will consistently meet the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practice and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

  • Cleaning Validation, Process validation, Analytical method validation, Equipment, Computer System Validation (CSV, GAMP)

Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

  • Validation Planning
    • Design qualification (DQ)
    • Installation qualification (IQ)
    • Operational qualification (OQ)
    • Performance qualification (PQ)
  • Validation Reporting
Compliance Control have been involved in hundreds of validation projects ranging from Manufacturing, Laboratory, Clinical, Equipment and Computer Systems Validation


     
     

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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