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...
by Lean Biologix | Aug 22, 2022 | Supply Chain Testing
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. As the primary indication was targeted for fatal neuromuscular genetic disease...
by Lean Biologix | Aug 22, 2022 | Supply Chain Testing
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...
by Lean Biologix | Aug 5, 2022 | Supply Chain Testing
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...
