Across the globe in today’s rapid pace environment, regulated companies in the blood and tissue industry are seeking to new technological innovations to address their unique challenges while optimizing processes and efficiency. Compliance is at the very core of every aspect of the business. Risk management ensures that compliance is achieved at each step and thus minimizes potential risks to the patient. The FDA released its publication “Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility”, issued April 2013. The guidance covered software designed to be used in a blood establishment and intended for use in the diagnosis of disease or other conditions in donors, or in the prevention of disease in humans by preventing the release of unsuitable blood and blood components. In summary, the guidance recommends a risk-based approach.
From the standpoint of validation testing, the guidance states “Your records should include documented evidence of all test cases, test input data and test results. Test results should include screen prints. For traceability purposes and to facilitate quality assurance review and follow-up, we recommend that any supporting documentation, such as screen-prints, where appropriate, be identified to link them to the specific test case…”
Capturing the right amount of validation due diligence is key. Given that the Agency would like screen prints as documented evidence as well as traceability, this can be difficult given manual processes.
Today’s forward-thinking blood and tissue organizations are GOING LEAN.