The SW environment should represent as close as possible the production environmentįor example, if the test environment uses a process controller of the same type as the production environment, then the substitution probable introduces low probability if invalid test results in the production environment. Test SW representing part of the production environmentĪ separate test system Representative Test Environment Test SW can also be categorized according to both GAMP 4 SW category and its function within the test environment: Removal of the temporary modification should be documented as well Good Automated Manufacturing Practice (GAMP) Software (SW) Environment Test If the test HW is added in the way that it may appear in the production environment, then, this should be documented a temporary modification to the production system.
#GAMP SOFTWARE CATEGORIES SERIAL NUMBERS#
If, however, the network cabling in the test environment is uses short patch cables, whilst the real environment has cable runs close to the maximum recommended length, there is clearly a possibility of different network behavior, and additional tests on site may be needed to prove proper network performance Control of Test Environmentįor standard HW (per GAMP 4 HW Category 1), the manufacturer’s reference and serial numbers should be recorded.įor custom HW (per GAMP 4 HW Category 2), the version of the item and its controlling specification should also be recorded.įor all test HW, any applicable calibration status should be recorded in the context of the specific Removal from Production Environment Test HW representing part of the production environment, which may be needed because it is not feasible to include a certain element of the production system in the test environmentĪ separate test system, which may be used to represent an external system Representative Test EnvironmentĪs started previously, the HW environment should represent as close as possible the production environmentįor example, if the test environment uses a standard network hub of the same type as the production environment, then the substitution probable introduces low probability if invalid test results in the production environment. Part of the system under test, i.e., part of the production HW HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function within the test environment. ולידציה – GAMP – Hardware & Software Test Environments Good Automated Manufacturing Practice (GAMP) Hardware (HW) Environment Test