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