Validation is more than having a set of screen captures showing your processes. Validation should include verifying the system against a set of requirements - statements on how you want your system to work. You also need to perform a risk analysis of the system functionality and requirements and then validate the highest risk items. You want to challenge your software, not only to ensure compliance but to ensure that the system provides patient safety. Proof of performance - either screen captures, video captures, or reports - should be made to demonstrate that your defined requirements were meet. Documentation of validation, including requirements, test scripts, proof of performance, issues found, conclusions, and review, can be kept electronically as long as you can find what you need when you need it. Kathy Patterson, MT(ASCP)SBB
