Driving Lean Validation Processes in CRO/CMOs


CRO/CMOs are experiencing an expanding global market.  As companies endeavor to do more with less, over the past 20 years, outsourcing has seen a significant surge.  Increasingly, companies are outsourcing mission-critical cGxP regulated processes and product manufacturing. Leading companies across the globe rely on Contract Manufacturing Organizations (CMOs) and Clinical Research Organizations (CROs) to improve operational efficiency and productivity. 

However, for all its benefits, outsourcing can also present unique challenges to any organization.   Global regulatory requirements, GxP compliance, and quality are becoming increasingly more complex as greater risk is assumed by the company.  The CRO/CMO business model is not designed to absorb high levels of risk therefore many of them are going LEAN.



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Lean Thinking in CRO/CMOs

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.