by Lean Biologix | Nov 19, 2023 | Supply Chain Testing
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...
by Lean Biologix | Nov 19, 2023 | Supply Chain Testing
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...
by Lean Biologix | Jun 11, 2023 | Supply Chain Testing
The purpose of this article is to explain why you may choose an established ISTA profile in lieu of using a custom profile for OQ temperature validation studies. The established ISTA ambient profiles are industry tested and widely accepted globally, whereas custom...
by Lean Biologix | Feb 9, 2023 | IT Project Management
The Software Development Lifecycle (SDLC) is a main component of GMP computer system validation (CSV). In the life sciences industry, regulators audit companies using the gamp 5 guidelines for gamp 5 validation alongside FDA 21 CFR part 11 requirements. Maintaining...
by Lean Biologix | Jan 9, 2023 | Supply Chain Testing
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...
