International pharmaceuticals company Pharmaceutical Development and Manufacturing Services Limited (PDMS) has selected an ERP solution based on TROPOS from SSI as the core management system for its expanding global services business. TROPOS will help competitive positioning for PDMS by integrating client services with improved materials and manufacturing planning. It will ensure compliance with essential industry regulatory requirements including FDA Title 21 Code of Federal Regulations (21 CFR Part 11), and enable group wide financial reporting.
Northern Ireland based PDMS is an outsourcing partner to the international pharmaceutical and biotechnology industries. Originally the formulation and manufacturing arm of Galen Limited, PDMS became a separate commercial operation in December 2003. Since then, it has grown its business to manage 220 product lines for clients in North America and Europe. Now part of Almac Sciences, PDMS plans to expand its customer base and its drug formulation business.
"To manage and grow a successful business in a highly competitive and regulated marketplace, we knew we needed better scheduling, forecasting, purchasing and stock control," says PDMS Managing Director, Graeme McBurney.
"We were constrained by manual processes for reporting and scheduling. We had to calculate our material requirements manually which meant if we encountered any changes to our forecasts we had to go back and re-calculate."
PDMS had four main objectives for a new system platform in mid 2004. It wanted automated real-time management reporting and the flexibility to run reports with good query options, so that it could schedule and forecast efficiently, and manage and value stock cost-effectively.
To improve its client services, PDMS wanted to integrate sales ordering processes with Material Requirements Planning (MRP) to produce real-time customer reports. To compete successfully for North American business, it needed to comply with the FDA 21 CFR Part 11, which includes requirement for electronic records and signatures. PDMS also needed the ERP, manufacturing and supply chain system to provide tightly coupled integration with Almac Sciences' standard financial reporting software Oracle Financials.
PDMS conducted a detailed requirements analysis in 2004 and initially engaged 11 potential suppliers for a replacement 50 user system. Following a filtering process, three short-listed suppliers, including SSI, were invited to present demonstration workshops. SSI was scored as the lead candidate. Following reference visits to other TROPOS customers in pharmaceuticals development and manufacturing, SSI was awarded the hardware, software and services contract in April 2005.
The software modules selected include TROPOS Pharmaceutical Manufacturing and TROPOS Supply Chain. PDMS is also taking TROPOS Application Development and TROPOS Integration Tools, Cognos Business Intelligence, Oracle Database and Oracle Financials. Hardware includes HP Application and Web Servers, using Windows, and Radio Frequency mobile data collection devices for manufacturing materials and data tracking. SSI will supply implementation consultancy, project management, technical and application training and support services.
Graeme McBurney, whose personal sponsorship of the project indicates its importance to the company, says that PDMS chose the TROPOS solution mainly because "TROPOS fitted with our business practices and our plans for future integration with other manufacturing execution systems (MES). It also had good practical add-ons, like the reporting toolbox. And we knew that TROPOS integration with Oracle Financials was proven."
PDMS also responded well to SSI's genuine interest, experience and openness about the solution's capabilities, including areas where configuration would be required to meet specific requirements. It liked the fact that TROPOS is SSI's own product. "We felt more than happy that the SSI people understood their own product well, and had good knowledge of the needs of our industry and regulators."
SSI Managing Director, Trevor Lewis believes that SSI was able to exhibit its specialist capabilities in winning the PDMS contract. "ERP and manufacturing solutions for regulated manufacturers are our key specialisation at SSI. So I'm delighted that this came across so strongly to PDMS. We are very proud that PDMS has chosen a TROPOS platform. It enhances our position in this very demanding market sector."
"We are looking for international success in our current and new market sectors", says Graeme McBurney. "We think PDMS has the right business infrastructure in plan to help us achieve that. The TROPOS solution will meet our immediate ERP, client and regulatory requirements, but it's also flexible enough to grow and integrate with other systems in future."