Putting Together the Pieces - Pharmaceutical Technology

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Putting Together the Pieces
Several strategies and software applications help pharmaceutical companies integrate their manufacturing execution systems and enterprise resource planning systems


Pharmaceutical Technology
Volume 32, Issue 10, pp. 40-46

Integration also enables production orders to be sent to the plant floor—or multiple plant floors—quickly. Manufacturing personnel can thus fulfill orders sooner and reduce cycle time.

Tight integration of MES and ERP systems provides accurate inventory counts to the enterprise level and also ensures that a company only picks released material for batch manufacturing. Integration prevents the site from "using batches that could be quarantined," Leinbach says.

If the ERP system is integrated with MES and other systems, with a laboratory information management system (LIMS), for example, it can facilitate batch release, says Rolf Blumenthal, senior director of international consulting at Werum Software and Systems (Lüneburg, Lower Saxony, Germany). For example, the ERP system can collect the MES batch records for approval along with the inspection data from the LIMS system and present them together, thus providing improved visibility of information.

If a company has unconnected information systems, collecting and collating data for document requests during inspections by the US Food and Drug Administration is a considerable effort, according to Herschel Kenney, senior director for IT planning and resource management at Purdue Pharma (Stamford, CT). MES–ERP integration speeds up this process by collecting the data in real time and allowing manufacturers to submit them to inspectors in minutes.

MES–ERP system integration also has advantages for manufacturers even before they face inspections. MES and LIMS reduce the time needed for compliance activities. Because they automatically check equipment, materials, and production data, these systems, when properly integrated, make results available to the ERP system, which allows management to respond to exceptions or failures quickly. SAP's ERP system includes tools that ensure audit trails and electronic signatures, says Mandar Paralkar, one of the company's solution managers for life sciences. These functions help reduce the occurrence and effect of products manufactured outside specifications and enable the company to maintain regulatory compliance more easily.

How do you do it?

The right information infrastructure, tools, and applications are prerequisites for integrating MES and ERP systems.


Figure 1: The manufacturing levels described in the Instrumentation, Systems, and Automation Society ISA-95 standard., Illustration by M.McEvoy. Images: James Hardy, AtomicSupersonic, Photodisc (Getty Images)
Standards. Because manufacturing plants are not all built the same way, pharmaceutical companies need standard processes and definitions to choose the kind of information to communicate between the MES and the ERP system. ERP-system vendors point out that the ISA-95 and Manufacturing Enterprise Solutions Association (MESA) International standards provide a strong foundation for integrating enterprise and production systems (see Figure 1). For example, Sabogal says SAP uses ISA-95 and MESA to identify the key business processes, interfaces, and integration points essential for this integration. And SAP's software presents process orders to the production level in the ISA-95 standard.

Blumenthal says that Werum based its recently developed "PAS ECMI" software package on the ISA-95 standard. The product is designed to directly integrate SAP's ERP system with Werum's MES for certain defined business processes in the weighing and dispensing area.

It's also important to standardize MES and ERP systems within an organization. "If you have one or a limited number of SAP instances, and they're all the same, then integrating MES and SAP can be simplified and the risk reduced" because only two applications (i.e., one MES and one ERP) are being integrated, says Richard Lemire, head of global production IT at Novartis (Basel).

Shared languages. Companies can simplify integration further by choosing a single format in which standardized MES and ERP systems communicate data within a messaging layer. A precedent has already been established, according to Kenney. "Right now it looks like XML is going to be the leading language for integrating packages," he says.


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