The Computerized System Validation (CSV) package of documentation for IQ follows the standard model discussed in Chapter 4, but with a strong emphasis on the ongoing documentation of physical and logical system control. (p. 155)


Figure 6.2 illustrates the IQ variation on the standard package model theme.

The focus of an IQ Package is the installation and ongoing compatible intended performance of the hardware, software, communications, and other infrastructure needed to deliver a software application to its GXP regulated work process. The functions of the GXP application itself are not a focus for the IQ. The GXP application’s ability to interact with the infrastructure is its focus. Can the application open and reach its database? Can it file and print a record on expected devices? What is its disaster recovery process and priority? Is the application accessible across the network?

In IQ the Platform System is tested as a configured unit and not as individual pieces. A Platform Requirements Specification (PRS) describes the components and functions of the unit from both the IT and End User views, e.g., technology needs, user numbers, network locations, IT and User work process needs. IQ testing is performed against the PRS items. It is the IQ Package that gets lost with Cloud Computing unless up front negotiations are made with the supplier when contracting the service. Ongoing visibility for change control, backups, issue resolution and disaster recovery testing is needed.


Next Month: Installation Qualification (IQ) Package – Cloud Issues

Regulators agree that you can outsource services, but they insist that you cannot outsource your GXP responsibility. (p. 160)