Atmos, molecules, lab testing photo

Projects

Lean Biologix works with biotech industry leaders ensuring they meet strict regulatory filing deadlines and compliance initiatives in supply chain and IT operations.

Automated Computer Software Assurance

Automated Computer Software Assurance

Continuous Computer Software Assurance (CCSA) The modern computer software assurance model champions a computer system validation program with effective risk assessment processes.  Life science companies have streamlined processes and are focused on meaningful testing...

What to Ask a Shipping System Vendor?

What to Ask a Shipping System Vendor?

Why choose a pre-qualified shipping system? At some point when designing a supply chain, a system for transporting the product must be developed or selected from available shipping system vendors. The most straightforward and least time intensive option is selecting a...

Comparing ASTM D4169-16 to ASTM D4169-22

Comparing ASTM D4169-16 to ASTM D4169-22

What is ASTM D4169 testing? ASTM International developed the standard ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” to test a shipping systems’ ability to withstand typical distribution hazards that occur in a supply...

Gene Therapy Shipping Qualification

Gene Therapy Shipping Qualification

A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market. Internal stakeholders needed to tightly manage the timeline required for...

Whitepaper:
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.

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