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 | 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 | Jul 19, 2022 | IT Project Management
A Global Fortune 500 life science organization desired to streamline their Cambridge, MA site CMMS parts ordering process allowing managers to level set periodic ordering costs. Lean Biologix developed and implemented an integrated PM parts forecasting and kitting...
by Lean Biologix | Jul 19, 2022 | Facility and Asset Management, IT Project Management
A world leading Biopham manufacturer decided to transition their manufacturing work orders from paper to an electronic process during an upgrade of their global Computerized Maintenance Management system (CMMS). This was a huge undertaking given the amount of assets...
by Lean Biologix | Jul 19, 2022 | IT Project Management
A Fortune 500 life science organization desired to implement a multi-site, GMP validated Process Analytical Technology (PAT) system. This initiative was part of a parent project to align with its Pharma 4.0 initiative to embed digitalization into the manufacturing...
by Lean Biologix | Jul 19, 2022 | IT Project Management
A Fortune 500 life science organization desired to implement a multi-site, GMP validated TIBCO® Data Science / TIBCO Statistica™ enterprise software solution. The software enables users to solve analytical challenges and to generate knowledge from processes and...
