Brief Description
The Computer Validation Operational Qualification / Performance Qualification (OQ/PQ) protocol is used to confirm that a computerized system works correctly and performs as described in the URS/FRS. It checks important system functions through planned test cases and defined acceptance criteria. Risk analysis is used to decide which functions need detailed testing based on likelihood, impact, and detectability of possible failures. Each test case includes challenge steps, expected results, actual results, and a final status such as Pass, Pass with Limitations, or Fail. Supporting evidence, including screenshots, reports, and raw data, is attached to the test record. Any incident, limitation, or failure found during testing must be documented, reviewed, and resolved. The OQ/PQ is considered complete only when all required tests are executed and reviewed, all acceptance criteria are met, and all incidents are properly closed. This process provides documented evidence that the computerized system is suitable for its intended use.
Impact Assessment
The OQ/PQ protocol will have a positive impact on computer system validation by making testing clear, controlled, and properly documented. It confirms that the system works according to the approved URS/FRS requirements. Risk assessment helps identify important functions that need testing based on likelihood, impact, and detectability of possible failures. Test cases provide clear challenge steps, expected results, actual results, and acceptance criteria. This helps users easily identify whether a test has passed, failed, or passed with limitations. Any incident or system limitation found during testing must be recorded, investigated, and resolved before completion. Supporting documents such as screenshots, reports, and raw data improve traceability and provide evidence of testing. Review by User Department, IT, Computer Validation, and Quality Assurance improves control and accountability. Overall, this OQ/PQ process reduces system-related risks, improves data reliability, ensures proper documentation, and provides confidence that the computerized system is suitable for its intended use.
Questions & Answers
Q1. What is the purpose of the OQ/PQ Protocol?
Answer: The purpose is to verify that the computerized system works correctly according to the approved URS/FRS requirements.
Q2. What does OQ stand for?
Answer: OQ stands for Operational Qualification.
Q3. What does PQ stand for?
Answer: PQ stands for Performance Qualification.
Q4. What is a Traceability Matrix?
Answer: It links each URS/FRS requirement with the related OQ/PQ test case used to verify that requirement.
Q5. Which factors are considered during risk assessment?
Answer: Three factors are checked: Likelihood, Impact, and Detectability. Each factor is rated as 1, 2, or 3.
Q6. When is a system function required to be tested?
Answer: If the total risk score is 5 or more, the function is tested. If the score is 4 or less, testing is not required under this protocol.
Q7. What information is recorded in a test case?
Answer: A test case includes challenge steps, expected results, actual results, Pass/Fail status, initials, date, and supporting evidence.
Q8. What are the possible final results of a test case?
Answer: The result can be Pass, Pass with Limitations, or Fail.
Q9. What should be done if a test fails or a limitation is found?
Answer: An incident should be documented and handled according to the Incident Management procedure.
Q10. What supporting documents can be attached during testing?
Answer: Raw data, screenshots, reports, computer-generated data, and other supporting documents can be attached.
Q11. Who reviews and approves the OQ/PQ document?
Answer: The document is reviewed by the User Department, Information Technology, Computer Validation, and Quality Assurance.
Q12. When is the OQ/PQ considered complete?
Answer: OQ/PQ is complete when all test cases are executed and reviewed, all acceptance criteria are met, and all incidents are properly documented and resolved.