Projects
Lean Biologix works with biotech industry leaders ensuring they meet strict regulatory filing deadlines and compliance initiatives in supply chain and IT operations.
Comparing ASTM D4169-22 to ASTM D4169-23e1
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...
Navigating the Gauntlet: ASTM D4169 vs. ISTA Distribution Tests
ASTM D4169 vs. ISTA Distribution Tests Two (2) prominent organizations lead the way in developing distribution standards: the American Society for Testing and Materials (ASTM) and the International Safe Transit Association (ISTA). This article will compare ASTM D4169,...
GAMP5 – Improved Guidance for Computer System Validation
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...
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?
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
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...
Supply Chain Considerations: ISTA Thermal Profiles for Shipper OQ
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...
What is Software Development Lifecycle (SDLC) and how does it relate to Computer System Validation
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...
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...
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...
Overcoming a Challenging In-Country Distribution Model
A leading fortune 500 company headquartered in Cambridge, MA was planning to launch a number of biological products into new markets for the first time. Product specific shipping qualification was performed and qualified shipping containers were in use for domestic...
CDMO Platform Shipping Strategy/Qualification
A leading cell and gene therapy CDMO located in Cambridge, MA desired to qualify and implement platform shipping systems that could maintain their product requirements and regulatory compliance. Challenges Aggressive timeline to complete qualification and...
Lab Equipment Inventory Project
One of the largest Biotechnology companies in the world with thousands of laboratory instruments needed to an accurate inventory of their research equipment. The project scope was for all 3 sites worldwide across many departments, system owners and service...
Clinical Drug Packaging and Labeling Operation
The world leader in neurological therapies initiated a plan to bring their clinical packaging from a CMO to an in-house operation. The plan required tripling the current operational capacity. Summary of Engagement Lean Biologix instituted several process improvement...
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.