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- Computer System Validation
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Understand the requirements
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2
Plan the testing strategy
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Execute the testing activities
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4
Evaluate the testing outcomes
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Here’s what else to consider
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Computer system validation (CSV) is a process of ensuring that a software system meets the intended purpose and quality standards of the user and the regulator. One of the key steps in CSV is to define the scope of performance qualification (PQ) and user acceptance testing (UAT) for a new software system. PQ and UAT are two types of testing that verify the functionality and usability of the system in the operational environment. How do you define the scope of PQ and UAT for a new software system? Here are some tips to help you.
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1 Understand the requirements
The first step is to understand the user and regulatory requirements for the system. These requirements should be documented in a user requirement specification (URS) and a functional specification (FS) that define the expected features, functions, and performance of the system. The scope of PQ and UAT should be based on the URS and FS, and cover all the critical and high-risk aspects of the system.
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2 Plan the testing strategy
The next step is to plan the testing strategy for PQ and UAT. This involves defining the test objectives, test cases, test data, test procedures, test acceptance criteria, and test roles and responsibilities. The testing strategy should be documented in a test plan that outlines the scope, approach, schedule, resources, and deliverables of the testing activities. The test plan should also specify how the test results will be documented, reviewed, and approved.
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3 Execute the testing activities
The third step is to execute the testing activities according to the test plan. PQ is usually performed by the system developer or vendor, while UAT is performed by the end users or representatives. PQ tests the system against the FS, while UAT tests the system against the URS. Both tests should be conducted in a controlled and realistic environment that simulates the actual operational conditions. The test results should be recorded in a test report that summarizes the test findings, issues, and deviations.
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4 Evaluate the testing outcomes
The final step is to evaluate the testing outcomes and determine if the system meets the requirements and expectations. The test report should be reviewed and approved by the relevant stakeholders, such as the system owner, the quality assurance team, and the regulatory authority. The review and approval should be based on the test acceptance criteria and the risk assessment of the system. If the system passes the PQ and UAT, it can be released for production use. If the system fails or needs improvement, corrective actions should be taken and retesting should be done until the system is validated.
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5 Here’s what else to consider
This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?
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Computer System Validation
Computer System Validation
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