We have core expertise in the regulatory, compliance and validation requirements for the Life Sciences, from development, testing and manufacturing to distribution. Our EAM solutions offer measurable–and sustainable–compliance and workflow improvements.
Case Studies in Life Sciences
With over 146 years of experience, Mallinckrodt Pharmaceuticals specializes in the development, production, and distribution of specialty pharmaceutical & medical imaging products. Headquartered in St. Louis, Missouri, this multi-billion dollar global company employs over 5,500 people worldwide.
- Created a standardized process, with both business & technical flows
- Delivered validation documentation
- Created & updated FRS, DDS, SOP as appropriate
- Built import/export routines
- Provided non-standard import/export objects for data sheets
Banetti has led Mallinckrodt through a Global Calibration Standardization, creating a foundation for success through the implementation of standardized processes.
- Standard Process Solution
- Post go-live support
Banetti's continued project guidance with Mallinckrodt has focused on ongoing support of Lab and Manufacturing Facilities.
This company is one of the largest medical device and diagnostic company in the world, employing hundreds of thousands of people.
Banetti has supported the company in a multi-year effort to adapt and deliver this Enterprise Asset Management Solution on IBM Maximo. To establish a foundation for success, the first major initiative included the strategic and technical underpinning to support an enterprise level, single instance of Maximo.
- Upgrade from Maximo 5.2 and 6.2 to 7.5.
- From 38 sites with a mixed solution to a single consolidated platform of 7.5.
- Enterprise visibility across the portfolio.
- Manage more than 100,000 assets.
- Manage more than 200,000 inventory items.
- Manage more than 5,000 users.
- Provide training across NA, Europe, and Asia.
- Train 30+ sites in 3 months.
- Post go-live support
- Provide support to 30+ sites in 3 months.
This initiative provided a global process standardization and harmonization throughout business centers. Furthermore, based on selected site assessments we were jointly able to identify opportunities for additional operational process optimization and efficiencies. The foundation for the site assessments was supported by the consolidated data generated by Maximo.
The continuation of project support for this company has focused on an ongoing Asset Management Improvement and ROI initiative.
- Initial focus on 8 sites
- Focus Areas - PM performance, unplanned downtime, inventory management
- Identified over $20M in ROI opportunities
- Phase 1 resulted in 20x ROI to spend ratio
- Inventory Spend
- Asset Efficiency
- Building KPI and Metrics
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