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

XML provides a format to exchange information about items such as orders, materials, and the status of an operation. SAP software supports XML for "the customers who are ready to use cutting-edge technology," adds Paralkar.

Novartis's harmonized MES and ERP systems use adapters that convert messages into XML so they can be exchanged, Lemire explains. He says that this solution is easy and takes only hours to execute. Similarly, Wyeth uses IBM's "MQSeries Integrator" application as an interface between its MES and ERP systems. The integrator converts XML messages into readable formats so they can be exchanged between the ERP system and MES.

In addition to XML, which defines the general structure of data to be exchanged, manufacturers need a specific way to define data content. SAP developed the intermediate document (IDoc) structure to enable data interchange and distribution through electronic messages.

Many companies now use Business to Manufacturing Markup Language (B2MML), which consists of XML schemas that implement the data models in the ISA-95 standard, to exchange data between their production and enterprise levels. When Genentech (San Francisco, CA) began integrating its MES and ERP systems, "SAP was publishing messages in the IDoc structure, and we had to convert them into the B2MML format" to communicate with the MES, says Govi Sridharan, senior automation engineer at Genentech. The conversion required Genentech to build custom integration. The widespread adoption of B2MML led SAP to provide B2MML content packages.

Messaging layer. Establishing uniformity within the messaging layer also helps integrate a single ERP system with various MES systems. Genentech bought manufacturing facilities that used different MES systems from the one used at the company's other production plants. "We actually used the messaging layer for standardization," Sridharan says. The company gave the new plants the necessary touch points to publish data in a standardized XML format and introduced them to its common messaging layer. The strategy allowed Genentech to successfully integrate its ERP system with three different MES systems.

Middleware. Middleware can enable production-level applications to view enterprise-level information. For example, business application programming interfaces (BAPIs) facilitate external access (e.g., by an MES) to business data in SAP's ERP system. BAPIs also enable data exchange between MES and ERP systems, says Paralkar.

Workflows. Pharmaceutical manufacturers also should create clear workflows to assign responsibility for each part of the production process to their MES and ERP systems. Blumenthal says that when a company's business processes are well-known, tight integration is easy and systems can be deployed without customization. If a company does not use best-practice business processes, the software vendor must take time to understand these processes to adjust standard data migration exchange for each of them.

Procedures such as documenting, measuring, and mitigating risk are performed in more than one IT system, notes Ruediger Dorn, managing director of the pharmaceutical industry at Microsoft (Redmond, WA). Microsoft's "Sharepoint"-based solutions can establish an infrastructure that provides uniform workflows to MES and ERP systems. This arrangement facilitates a continuous trail of control and allows companies to document a process, identify the employees who modified it, and prove the results. This information must ultimately be accessible to the ERP system, he explains.

Integration and intelligence platform. SAP's "Manufacturing Integration and Intelligence" (MII) platform is a solution that allows users to bridge the gap between SAP's ERP system and plant-floor systems such as MES and LIMS. Andy Dé, SAP's senior director of solutions marketing in life sciences, says MII includes prebuilt adapters for the most common MES, LIMS, and quality systems. Once MII has been implemented, it extracts real-time data from the user's plant-floor and ERP systems and presents them within role-based dashboards. MII delivers analytics, reports, and alerts to improve decision-making and monitor performance. Firms such as Merck, Wyeth, Roche, and Novartis are using MII to integrate their MES and ERP systems.


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