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In a validation project, Tests Plans or Test Protocols are used to demonstrate that a system meets requirements previously established in specification, design, and configuration documents. Test Plans document the general testing strategy; Test Protocols are the actual testing documents. In many cases, the Test Plan and Test Protocol are combined into a separate document.
The Test Plan outlines the testing requirements and strategy. It should include the general process for performing the testing, documenting evidence of testing and the process for handling testing failures. The Test Plan may also include the types of testing, descriptions of environments where testing will be performed, who is responsible for testing, equipment or testing that will be used in testing, or other organizational requirements for testing.
Test Protocols describe the specific testing. Test Protocols are collections of Test Cases which check a specific element of the system. Each test case should include the purpose of the test, any pre-requisites that need to be done before testing, and the acceptance criteria for the test.
Each test case is made up of a series of test steps. Each step should include an instruction, an expected result, and the actual result. The instructions should include enough detail so that a tester can consistently perform the required testing activity. There should also be a place for the tester to assess whether each step passes or fails.
The process of following the instructions and recording the results is called “executing” the protocol. When executing test protocols, the tester should follow established Good Documentation Practices. This includes using a compliant computer system to record the testing results or documenting the results on paper and pen. Any discrepancy between the expected result and the actual result should be tracked as a deviation. Deviations should be resolved before validation is complete.
Software validation usually uses three specific testing protocols:
Engineering Validations sometimes use two additional testing protocols:
Test Protocols should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.
Q: Can I document test cases using MS Word or MS Excel?
A: When electronic systems are used to perform regulated processes (like the verification of validation test protocols), they need to be compliant with 21 CFR 11. MS Word and MS Excel do not, in their out-of-the-box state, have the necessary technological controls, like individual user passwords or audit trails, required to be compliant with electronic records requirements such as 21 CFR 11 or Annex 11.
Q: How does Ofni Systems document validation testing?
A: At Ofni Systems, we use FastVal to execute test protocols electronically. This allows us to execute protocols to ensure requirement traceability and to generate the actual requirement traceability document. Other organizations might use Excel spreadsheets to keep a table of requirements, despite this being extremely difficult to maintain manually.
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The following terms or abbreviations are sometimes used: Installation Qualification, Operational Qualification, Performance Qualification, Factory Acceptance Testing, User Acceptance Testing, Site Acceptance Testing, Factory Testing, User Testing, Site Testing, Acceptance Testing, FAT, SAT, UAT, IQ, OQ, PQ.