IT Network And Infrastructure Qualification

The following Library section covers the increasingly important area of regulatory compliance in the IT Departments of the pharmaceutical and other regulated industries.

• Network Qualification
  The principles of network qualification and an overview of how to qualify IT networks using a simplified V model approach.
• Case Study Of Network Qualification
  Co-authored by Jeremy Benson and Martyn Smith (Vectura Limited) and David Mole and Bob McDowall (McDowall Consulting) the first part of a case study on qualifying a new computer network and infrastructure. It deals with controlling the work (via a network qualification plan) and specifying the network and infrastructure (via a network requirements specification). Risk mitigation is a key element of this approach.
• Regulatory Compliance When Outsourcing IT
  The regulatory compliance issues when outsourcing IT to a third party are discussed and debated. It is important to understand that the pharmaceutical company still retains the responsibility for regulatory compliance even though IT services are delivered by a third party.