As the verified integrated modules are combined with other verified modules, the number of interfaces grows, but testing can usually be restricted to verifying these interfaces and their impact on the overall functionality of the system. This system of modular testing follows the life cycle described in GAMP 4<\/a><\/p>\n Depending on the size and type of system, there may be several phases that support the validation process. These may cover all or some of them:<\/p>\n Test carried out by the supplier<\/p>\n Formal Factory Acceptance Testing (FAT) at supplier premises<\/p>\n Installation and commissioning testing, usually done by the supplier<\/p>\n Formal Site Acceptance Testing (SAT) to verify that the system meets the user requirements<\/p>\n Installation Qualification – \u00a0IQ<\/a><\/p>\n Operation Qualification\u00a0–\u00a0OQ<\/a><\/p>\n Performance Qualification\u00a0–\u00a0PQ<\/p>\n IQ<\/a> is typically conducted during the build of a qualified environment. OQ<\/a> and PQ of a system or application are typically conducted as part of qualifying a wider manufacturing or business process. The relationship of the IQ, OQ and PQ to the testing of systems or applications should be clearly defined.<\/p>\n :For each project, the Test Plan or Strategy document should define the test phases required, including<\/p>\n Location and timing of the tests.<\/p>\n Responsibilities (for example, for test execution, review and necessary training<\/p>\n Required test coverage, based on risk assessment<\/p>\n Overview of the test environment<\/p>\n Documentation required, base documentation, such as Design Specifications<\/a>, Test Specifications or Protocols, Test Results Proforma, and Test Results required on test completion<\/p>\n \u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n
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