Validation Protocol StandardsThe following method of construction must be used. The over all protocol standards are shown in the SOP’ for the different protocols, here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a qualified person to ensure the system under test has been adequately tested. Each test must comprise of ;
Main Sub-headings in Test Script.
- A Rationale, giving the reason and or object of the test.
- A detailed Test Method.
- A detailed Acceptance criteria that the tests must produce.
- A Test Result confirming whether the test result, satisfied the acceptance criteria.
- The test result must be initialled by the person executing the tests, on completion or at each significant stage.
- Each test must be designed to verify an element of the equipment functionality.
- Each test must a have a result that is clear, unambiguous and known.
- The test method must call up for the recording of the test result parameters. (no ticks or tick boxes, no generalities).
- Each test must be witnessed or the results must be reviewed by a competent person.
- The overall test results must be approve by a competent person.
STANDARD PROTOCOL RELATIONSHIPS.
FULL LIFE CYCLE DOCUMENTATION RELATIONSHIPS.