Brief Description

This Computer Validation Operational Qualification (OQ) document is used to confirm that a computerized system works correctly according to the approved Functional Requirement Specification (FRS). It covers the functions intended for use at the company site and links each requirement with suitable OQ test cases. A risk assessment is performed by checking likelihood, impact, and detectability of possible failures. Higher-risk functions are selected for testing.

Each test case includes challenge steps, expected results, actual results, pass or fail status, initials, dates, and supporting evidence. Any limitation or failure found during testing is recorded as an incident and handled according to the validation plan. Test documents, screenshots, reports, and raw data must be properly identified, reviewed, and attached.

The OQ is considered complete when all test cases are executed and reviewed, acceptance criteria are met, and all incidents are properly documented and resolved before final approval. This provides documented evidence of reliable operation.

Impact Assessment

This Operational Qualification (OQ) will have a positive impact on computerized system validation by confirming that the system works according to the approved Functional Requirement Specification (FRS). It uses risk-based testing to identify important functions and decide which requirements need testing. The traceability matrix helps link each FRS requirement with the related OQ test case. Clear test steps, expected results, actual results, and pass or fail status improve testing consistency and documentation. Supporting evidence such as screenshots, reports, and raw data provides better traceability. Any failure or limitation found during testing is recorded as an incident and investigated and resolved. The requirement for review, initials, dates, and approval improves accountability and data integrity. The OQ is completed only after all test cases are executed, acceptance criteria are met, and incidents are closed. Overall, this process reduces system risk and provides documented evidence that the system is suitable for intended use.

Questions & Answers

Q1. What is the purpose of Operational Qualification (OQ)?
Answer: OQ is used to confirm that the computerized system works correctly according to the approved Functional Requirement Specification (FRS).

Q2. What is checked during risk assessment?
Answer: Risk assessment checks the likelihood of failure, its impact, and how difficult the failure is to detect. Each factor is given a score from 1 to 3.

Q3. What information is recorded in an OQ test case?
Answer: The test case records challenge steps, expected results, actual results, pass or fail status, initials, dates, and supporting documents.

Q4. What happens if a test fails?
Answer: The failure or limitation is recorded as an incident and handled according to the Computer Validation Plan.

Q5. When is the OQ considered complete?
Answer: OQ is complete when all test cases are executed and reviewed, acceptance criteria are met, and all incidents are properly documented and resolved.