ולידציה Good Automated Manufacturing Practice – GAMP – Test Environments – Test Data Sets
Test data sets are often use where the test environment does no permit the use of real data for reasons of availability or confidentiality, or where the real data are not generic enough to cover certain test types (e.g., challenge testing at boundary conditions or stress testing).
Representative Test Environment
Test data should represent as close as possible the actual data to be operated on, in terms of volume and range of possible values (including invalid entries, to check that they can be correctly handled).
Differences between the proposed test data and the expected actual data should be detailed on the Test Specification or Protocol, and subject to impact assessment. If necessary, additional tests should be planned for the production environment in order to cover identified risk scenarios.
Control of Test Environment
Test data sets should be placed under configuration management and the version in use recorded.
For automatically generated data it may also be appropriate to control the utility used for generating the data, as well as the test data set
Removal from Production Environment
If the test data 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.
If the production environment includes automatic audit trailing, then it should be recognized that all audit trail entries from the testing process will remain.
Test User Accounts
Test user accounts are often used to permit testers to access the system at different levels, and ensure that activities carried out during testing are easily identified within any resulting audit trail.
Representative Test Environment
Where test user accounts are often used, these should be set up to represent each group of users within the system, including the corresponding authorizations. For multi-lingual system, test user accounts using foreign character sets should be included. Similarly, if existing individual accounts are used for testing, representatives from each group should be included.
Control of Test Environment
If test user accounts are used, then the setup of the accounts should be retained as part of the test documentation. Where there are issues of data confidentiality, controls should be exercised to ensure that the use of test accounts does not cause breaches of confidentiality.
Removal from Production Environment
If the test user accounts are 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.
Test Documentation
The test environment includes documentation used during testing. This should always include the test documentation (Test Plans and Strategies, Protocols and Test Specifications, Test Cases and Test Scripts) and the controlling Design Specifications. It may also include operating procedures such as SOPs.
The test documentation should be controlled and recorded to a level of detail that would allow it to be retrieved as part of later review of the test results. This control would, at minimum, include the recording of current document version levels.