Infrastructure Qualification White Paper Updated

Following the finalization of the GAMP "A Risk-Based Approach to Operation of GxP Computerized Systems" good practice guide we decided to update our "Pragmatic Infrastructure Qualification" white paper (available on the Business & Decision Life Sciences website).

Although originally written in 2005 the white paper had stood the test of time well - what we were promoting as industry leading best practice back then has now been adopted in the new GAMP good practice guide or in version 5 of the GAMP Guide. It just goes to show how best practice changes to become more widespread good practice over time.

Some of the regulatory references had become a bit dated and we're now also able to reference almost five years operation of own qualified Data Center where we host and manage client's regulatory significant applications (ERP, LIMS, Change Management etc) on our qualified infrastructure.

Although infrastructure qualification isn't quite the 'hot button' topic it was in the middle of the decade it's still something that needs to be addressed - the more cost effectively the better.

Over the coming months we're going to be running a series of webcasts to share some of this best practice with a wider audience and there are also plans to develop a new white paper looking at applying some of this best practice to new technologies such as virtualization and middleware and Service Oriented Architecture.