Operational Excellence for Life Science Manufacturers



Lean Biologix is a unique service provider for regulated manufacturers. We leverage a combination of current technology and lean principles to deliver efficient and manageable solutions. Our close integration with your internal resources lets us fully understand your problems to provide sustainable process improvements that have a lasting impact.


Learn how we apply these principles to your next project.

Evaluation of Shipping System Qualification Data

The Lean Process

Learn and apply industry best practices within your qualification processes to evaluate qualification data provided by thermal shipping system manufacturers and vendors. Leveraging pre-existing qualification packages is a tremendous time and resource.

Project Management

All Lean Biologix personnel are trained to effectively manage and execute projects through continuous communication and time management skills.

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We understand that compliance is critically important and believe that creating a simple, stress-free process is the key to maintaining control and eliminating deviations.


Lean Biologix has expertise in shipping qualification, CQV Testing, CSV using the GAMP 5 process.


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