Lean Thinking In Nutraceuticals


Nutraceuticals are products that provide health and medicinal benefits, including the prevention and treatment of diseases in addition to the basic nutritional value found in foodstuff.  The nutraceuticals industry is in a period of rapid growth in the U.S. and around the globe.   As the globalization of manufacturing and distribution continues, the need for stronger systems to assess and ensure quality in dietary supplements becomes more pressing.  Some manufacturers in the nutraceutical industry have had challenges with product and supply chain integrity and are adopting Enterprise Resource Planning (ERP) systems to address these challenges.    

Since 2010, nutraceutical companies are subject to cGMP regulatory guidelines, thus any systems deployed that manage GMP processes must be validated.  Given the market imperatives for greater efficiency and optimization, nutraceuticals are GOING LEAN.


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Lean Validation Best Practices

OnShore Technology Group is a pioneer in lean validation and has developed principles and best practices to support lean validation processes.  To power our lean processes, we leverage ValidationMaster™, an Enterprise Validation Management system exclusively designed to facilitate lean validation and automate the validation process.

Lean validation CANNOT be achieved without automation. Lean validation processes leverage advanced technology designed to fulfill the technical, business and compliance requirements for software validation eliminating the use of manual, paper-based processes. Optimized validation processes are deployed using the latest global best practices to ensure the right amount of validation rigor based on critical quality attributes, risks, Cybersecurity and other factors.


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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.