IT Infrastructure Qualification

As of 30th June 2012, Eudralex Volume 4, Annex 11 was updated to state that infrastructure must be qualified. For further details refer to the GAMP® Good Practice Guide: IT Infrastructure Control and Compliance, which has been created by a GAMP Special Interest Group.

By utilising the asset functionality in ComplianceControl Centre, specifications for your network component such as servers, PC’s, routers, switches, UPS’s can be recorded and managed, and your draft and issued qualification documentation can be stored and managed in the configurable workspaces.

The qualification process requires a formal documented qualification plan. Where appropriate asset management is not in place, the creation of a detailed network/infrastructure specification is required. A risk assessment to identify high risk network components, test specification, and documented test scripts, all collated and summarised in a qualification report.

As part of the overall qualification process, a detailed review of your supporting quality documentation is carried out, to help ensure that your network/infrastructure is managed in accordance with current good practice. The review will establish that where necessary, your company has the following documents in place. (Not exhaustive) Security Policy, Disaster Recovery Plan, Backup and Restore Procedure, Acceptable Use Policy, Network Access Management Policy, Server Management Policy.

It is also important that you have standard operating procedures in place to cover the qualification documentation requirements, and that your staff have been trained to use them. And of course the associated training records are available. ComplianceControl Centre has functionality for managing and storing your training records.

We have templates available for all the above so contact us now to get your infrastructure qualified or request us to do a free half day gap analysis and assessment.

The guide can be purchased through the ISPE website by clicking on the image








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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