Friday September 16, 2022
Organizations in the Life Sciences must confirm their systems are working to their intended uses based on compliance requirements set by governing agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), etc. The validation process includes Validation Test Scripts, a fundamental element of validation that provides the objective evidence required for compliance. Test scripts clearly define the overall purpose of a test case by defining the testing sequence of actions and expected results, along with other documentation that results in verifiable proof of a test objective.
Why is Test Script Development essential to the Life Sciences?
The Arbour approach flows from developing a clear Test Script Objective, set prerequisites, specific action steps, and the expected results. The process is ultimately refined using dry run and script revisions to acquire the final test scripts.
The test objective identifies the configuration or function to be demonstrated in test script development. Prerequisites are determined expectations to be satisfied before execution of the action steps. Action Steps reference the system or component being tested. Expected results consist of the desired outcome of an action step. Actual results state the outcome with the appropriate attached declaration, e.g., screenshots. A dry run test execution confirms the accuracy of a test script by using it against the actual system. It rids test script errors and limits the execution of the final test script to true errors. In a final script, a pass or fail decision is made after the actual results are documented and referenced.
Types of Test Scripts
Installation Qualification (IQ) test scripts confirm that the vendor installation requirements are installed accurately in a suitable environment. IQ test scripts are executed in a controlled validation environment as well as in the production environment.
Operation Qualification (OQ) test scripts determine if regulated functional processes test successfully based on pre-defined specifications, i.e., Functional Requirements Specifications are confirmed, and there are no apparent bugs in the operating system. Customizations to standard functionality are also tested. OQ testing is performed in a validation environment.
Performance Qualification (PQ) tests ensure end-to-end processes work as intended based on User Requirement Specifications. A validation testing environment is also used for PQ testing. It determines if a system works to its intended purpose and in unity with standard operating procedures.
Why Perform IQ OQ and PQ Tests?
When ready to test a system, a Validation Plan is created as a governing document. The Validation Plan includes the scope of the testing, deliverables, resources, risk approach, test methodology, roles, and responsibilities. IQ, OQ, and PQ testing are essential in demonstrating proper validation of a system’s intended purpose to regulatory bodies like the FDA and EMA. Software that is not validated can result in FDA observations that may include a Warning Letter or, in severe cases, a complete shutdown.
The Arbour Advantage
Test Script Development with Arbour Group’s industry knowledge and expertise reduces the overall cost of compliance. Software testing ensures compliance requirements are met, identifies risk factors, enhances productivity, and helps ensure project success. Contact us to discuss how we can raise quality levels while reducing costs.