Software makes compliance easy
Published: 5 March 2013 - Heather Ramsden
Pharmaceutical company Takeda Ireland has replaced an existing CMMS with an enterprise asset management (EAM) application that was not only compliant to FDA 21 CFR part11 (ensuring companies implement good business practices) but also able to drive a lean maintenance program
Takeda Ireland began manufacturing in 1999. In 2008 it became clear that a system upgrade was required.
Following an ambitious nine-month design and implementation Infor EAM went live in March 2010, across both sites in Ireland.
Infor EAM is a powerful system for keeping the equipment, facilities, and vehicle assets of a business in the best shape in order to maximise profits. It can help cut purchasing costs, inventory levels and carrying costs, while making workers more productive.
Within just over a year, EAM has helped Takeda deliver a paperless work flow, eliminating 20,000 paper orders. Technician utilisation has increased from 40 per cent to 93 per cent. Planned versus reactive work has doubled and administration time has been cut by 2.5 hours a day.
“In a short period of time we have taken the system to a point where we are now reaping the benefits of real world accurate data on which to base our analysis and changes in our drive to achieve a lean maintenance system,” says Anthony Cantwell, maintenance manager, Takeda Ireland.
“Even in a heavily regulated industry like pharmaceuticals the application allows you to apply innovative approaches whilst maintaining the integrity of the database. The trick to getting the most from Infor EAM is recognising the potential in using the tools within it in a collaborative way and applying innovative solutions to add the maximum value possible.”
Ensure compliance with stringent FDA 21 CFR Part 11 regulations on electronic records and electronic signatures.
Implement a scalable system that provides efficient data delivery, allows for growth, and drives improved manufacturing practices and lean maintenance requirements.
Allow easy system design changes to meet evolving customer needs.
Eliminated 20,000 paper work orders per year through a streamlined workflow process combined with electronic approval signatures.
Gained big improvements in technician use—from 40 per cent to 93 per cent—as well as percentage of technician time spent on planned versus reactive work—from 40:60 to 82:18.
Reduced administration time for the planner and technicians by 2.5 hours a day using the advanced report writing SQL queries and automating the planning and scheduling display and shift handover report.
Created a “visual factory” for real-time work orders and spare parts status that enhanced inter-departmental communication and engineering response times.
Gained ability to get instant updates on parts used versus waiting for month-end restock invoices, and to use the cost report during shift handover meetings, improving the technician and engineering approach and behavior on parts usage.
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Industry Connections: Infor