ComplianceControl Centre Non-Conformance

Managing Deviations, often called a Non-Conformance, is a vital part of any Quality Management system. Deviations must be raised, logged and tracked.

A key part of managing deviations, is to ensure that the deviation procedure is clear at the outset. Key here is to ensure that the definition of a Deviation is clear.

In relation to a pharmaceutical product a Deviation is where the normal day to day standard operating procedures have not been followed, or an issue or error has been noticed in the product or manufacturing process, in which case a deviation record must be created. When a deviation record has been created, typically by an operator or supervisor, the deviation must be assessed and review by management, including a Quality Assurance representative. The first assessment must be to actually agree that it is really a deviation. Once it has been formally categorised as a deviation then the ‘Corrective Action, or Preventive Action’ team must agree on the way that the current product, bacth, or issue is resolved, along with any Corrective or Preventive Actions, to ensure the Deviation does not occur again.

The Alert system will ensure that the owner of outstanding Deviations are alerted, prior to completion date to ensure timely response to outstanding actions.



     
     

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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