Going Lean In The Blood-Tissue Industry


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.


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Lean Validation Methodology

Lean validation is derived from the lean manufacturing process.  Simply put, lean manufacturing is the process of eliminating waste, minimizing risk and driving quality, efficiency and compliance.  A common misconception is that lean is suited only for manufacturing. This is not true. Lean principles may be applied to any process that would benefit from the elimination of wasteful activities and process improvement.  Lean validation thus is not a tactic or a cost reduction program, but a way of thinking and acting for today's validation team.  The figure below depicts the overall strategy for lean validation.



As highlighted above, lean validation requires automation.  ValidationMaster™ powers lean validation and is designed to facilitate automation throughout the process. The system manages the full lifecycle of validation processes and is designed to eliminate traditional manual, paper-based processes.  To learn more about how ValidationMaster drives lean validation processes, click the link below.

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Accelerate Your ROI

One of the key benefits of ValidationMaster™ and our lean validation services is the excellent return on investment of the overall solution.  ValidationMaster™ is a full, comprehensive Enterprise Validation Lifecycle Management and Quality system.  Beyond the initial validation exercise, ValidationMaster™ pays dividends well beyond the initial validation exercise.  Many companies have seen a 100% return on investment with the first project.

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We invite you to access our Resource Center and read more about our Validation Accelerators.  Our Resource Center includes case studies, marketing collaterals and data sheets, white papers and much more.  Read our blog branded as The Validation Post for more detailed indepth strategies, best practices and thought leadership on lean validation strategies, Validation Accelerators and the latest innovations for validation project management.

Innovation In Action

Life sciences companies across the globe are seeing the benefits of our ValidationMaster™ Enterprise Validation Management System and CloudMaster 365™.  Instead of getting a stack of documents from a vendor, CloudMaster 365™ provides you with the system, the documentation, the testing, and the processes to help deliver validation.  Our clients have added their own due diligence to ensure compliance with current regulatory guidelines. 

Mastering Regulatory Compliance

CloudMaster 365™ is compliant with current global regulatory guidelines.  The ValidationMaster™ Enterprise Validation Lifecycle Management system includes compliance with 21 CFR Part 11, change control, regulatory content management, incident management, CAPA, nonconformances, training and other regulatory processes.  The system is designed to work together in a cohesive manner to deliver maximum value for lean validation processes.