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 saver.

This strategic document covers evaluation of the following qualification data categories from shipping system manufacturers and logistics providers:


  • Thermal Operational Qualification
  • Distribution Operational Qualification
  • Performance Qualification

We qualify Biotech, Gene Therapy and Pharmaceutical manufacturers packaging and shipping systems within domestic and international supply chains.

Download the whitepaper to leverage our knowledge of regulatory requirements, industry standards and best practices to support all aspects of shipping qualification. We have a standardized process for managing shipping qualification programs that has been proven successful with regulatory agencies and eliminates “re-inventing the wheel” when developing or qualifying additional assets within a client’s portfolio.

“Our clients often ask us to outline our methods to help communicate qualification requirements internally, so LBX created a compact reference to guide them through our industry proven qualification processes to inform project stakeholders and to help manage project activities for their teams.”

Mike Reilly

VP, Lean Biologix