Projects
Lean Biologix works with biotech industry leaders ensuring they meet strict regulatory filing deadlines and compliance initiatives in supply chain and IT operations.
CMMS Parts Forecasting and Kitting
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...
ETOP Process for Therapeutics Manufacturing
The top RNAi Manufacturer built a new manufacturing site to support their new products. The site construction was underway without an established plan to collect and organize all of the construction, testing and commissioning documents. The goal was to generate an...
CMMS Transition to Electronic System
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...
Process Analytics Technology (PAT) System Implementation
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...
Advanced-analytics Platform Implementation
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...
CMMS Data Migration from Maximo to HxGN EAM
A Fortune 500 life science organization desired to standardize/streamline asset, work order, and procurement management for a newly acquired facility location and to use one CMMS system. The data migration was required because Maximo was to no longer be serviced or...
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.