Valideringslogs

Valideringslogs are records that document the process of validating a system, process, or data. In regulated industries, such as pharmaceuticals, medical devices, and finance, validation is a critical requirement to ensure that systems perform as intended and consistently produce accurate results. Valideringslogs serve as evidence of this validation activity, providing a traceable history of tests performed, results obtained, and any deviations or corrections made.

The content of a valideringslog typically includes details such as the system or process being validated, the specific version or configuration, the validation plan or protocol used, the dates of validation activities, the names of the personnel involved, and the specific test cases executed. Each test case should have a clear description, expected results, actual results, and a pass/fail status. Any discrepancies or failures must be documented, along with the investigation undertaken and the corrective actions implemented. Signatures and dates are crucial for confirming the completion and approval of each validation step.

The purpose of valideringslogs is to demonstrate compliance with regulatory requirements and internal quality standards. They are essential during audits and inspections, as they provide objective proof that validation has been performed thoroughly and effectively. A well-maintained valideringslog contributes to the overall integrity and reliability of the validated entity, ensuring patient safety, data accuracy, and operational efficiency.