The FDA requires that U.S. life sciences companies follow a computerized system validation process to verify and document that a computerized system is performing as expected per a set of defined requirements and specifications. Computerized system validation must be performed throughout the entire lifecycle of a system, from implementation to sunset. Here are some tips to help avoid common issues when planning and/or performing computerized system validation:
Good Documentation Practices
- Is justification provided for all changes to data and testing results along with the date and initials of the person who changed them?
- Are requirements easy to find in the provided screenshots or are there too many elements in the provided screenshots to focus on in an easy manner?
- If corrections to requirements are made, was a proper change request filed (unless the corrections were for spelling errors)?
- Are requirements ambiguous in that they could be interpreted in more than one way? Requirements should be singular and unique without “either/or” language.
Bridging the information gaps
- Do documents contain all key information and/or content?
Consistency
- Is there consistent use of terminology across documents?
Focus on the project
- Is CSV the main responsibility of project team members, or is it a side-project?
Distributing time and resources based on risk
- Are you planning to perform a risk-based analysis to identify how to properly allocate testing resources across low, medium, and high-risk requirements?
Thorough definition of requirements
- Do your requirements describe the required traits for data, user interactions with the business process, and key software functions? Or do they lack detail?
Complete test scripts
- Do test scripts fully address the corresponding requirement(s)?
Traceability
- Does your trace matrix account for all specifications and observation steps in the test scripts?
- Are all requirements linked to a test script, or at least have descendants that are linked to a test script? Are there any test results that are orphaned (not linked to a requirement or a parent test script with a requirement)?
- Are requirement details specifically numbered and traced to corresponding test steps? The reviewer should not have to infer detailed links between requirements and test script steps.
- Are you ensuring traceability for the third-party artifact verification?
Detailed test results
- Are the expected test results described in sufficient detail so that the actual results can be verified? The exact values that are expected should be provided.
- Are the actual test results documented in a way that is verifiable against the expected test results?
With these tips in mind, you can avoid many of the common problems that are encountered during computerized validation testing. To discuss the computerized system validation process further, please contact a member of the Prana Life Sciences team.
References:
Computer System Validation, FDA Requirements, Regulations &: Guidance (complianceonline.com)
How Computer Systems Validation Can Make or Break Your Business (biotech.com)
