by Lean Biologix | Jun 19, 2024 | Uncategorized
The GAMP5 second edition improved upon the original edition from 2008 and was released in July 2022. The updated guide keeps the same structure but updates its content to highlight the growing area of cloud services. It also addresses the increasing use of testing...
by Lean Biologix | Jan 12, 2024 | IT Project Management
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...
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...
