ולידציה - GAMP - Hardware & Software Test Environments
ולידציה - GAMP - Hardware & Software Test Environments.HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function withi…
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ולידציה - GAMP - Hardware & Software Test Environments Good Automated Manufacturing Practice (GAMP) Hardware (HW) Environment Test HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function within the test environment . It can be one o f these three things Part of the system under test, i.e., part of the production HW 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 environment A separate test system, which may be used to represent an external system Representative Test Environment As started previously, the HW environment should represent as close as possible the production environment For 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. 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 Environment For standard HW (per GAMP 4 HW Category 1), the manufacturer's reference and serial numbers should be recorded. For custom HW (per GAMP 4 HW Category 2), the version of the item and its controlling specification should also be recorded. For all test HW, any applicable calibration status should be recorded in the context of the specific Removal from Production Environment 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. Removal of the temporary modification should be documented as well Good Automated Manufacturing Practice (GAMP) Software (SW) Environment Test Test SW can also be categorized according to both GAMP 4 SW category and its function within the test environment: Part of the system under test, i.e., part of the production HW Test SW representing part of the production environment A separate test system Representative Test Environment The SW environment should represent as close as possible the production environment For 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. If, however, a particular interface is simulated in the test environment, a possibility remains that different timing factors or process dynamics could affect the operation in the production environment, and additional tests on the production interface may be appropriate Control of Test Environment For standard SW (per GAMP 4 SW Category 1, 2 or 3), the manufacturer's reference and version numbers (including installed patch cables) should be recorded. Any configuration or setup parameters should be controlled For configured or custom SW (per GAMP 4 SW Category 4 or 5), the item should be placed under configuration management and the version in use recorded Removal from Production Environment If the test SW 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. Removal of the temporary modification should be documented as well ולידציה - GAMP - Hardware & Software Test Environments