EAI tools. Enterprise application integration (EAI) tools, particularly those that offer application-interface level EAI, use the process and data interfaces that the source and destination systems expose to extract and translate information between two or more systems. Commercial offerings include IBM's "WebSphere," Microsoft's "BizTalk Server," TIBCO's application, and Oracle's "BPEL Process Manager," says Alison Smith, research director at AMR Research (Boston).

These EAI tools are much more sophisticated than MII, Smith says, because they're not specifically geared to SAP. Instead, they are designed for highly heterogeneous environments. The manufacturing industry is just starting to adopt these technologies, especially companies with an IT infrastructure complex enough to warrant a bus architecture that allows systems to exchange message-based information.

EAI tools require a level of IT expertise and architecture awareness that typically isn't found in operations environments, says Smith. MII is not a plug-and-play solution, either, because users must have HTML programming skills to realize all of the tool's benefits. "None of these tools is easy to use," Smith says. "Any way you cut it, you don't get to do these integrations in a purely point-and-click way."

Responding to demand, Werum is collaborating with its users to develop best-practice business-process descriptions. These descriptions are being transformed into reusable MBR parts and made available in libraries as typicals. The typicals will become part of Werum's MES and facilitate synchronization with SAP recipes, and thus integration with SAP's ERP system.

What's the answer?

Choosing the system of record. Various strategies and tools enable pharmaceutical companies to integrate their MES and ERP systems, although no current solution is ideal. Sabogal points out that a company must decide which of its IT systems is the system of record for regulatory purposes. Firms would be inclined to choose the system that could provide the relevant data the fastest during an inspection.

Yet the required data might not be stored in one place. The MES contains batch records, detailed workflows, recipes, and other manufacturing-process information. An inspector would need this data, but would also need information about ingredients and quality-control inspections from the LIMS and supply-chain data from the ERP system.

The ERP system should probably be the system of record because data about all of these elements ultimately flow to the enterprise level, advises Kenney. Though ERP systems do receive these data, such systems have traditionally focused on outcomes, planning, and timeliness of delivery. A thorough integration of the ERP system with MES and LIMS might be necessary for quality and compliance data to be available at the enterprise level.

Storing work-in-progress data. The question of where work-in-progress (WIP) data should be maintained is also important for regulatory compliance. When MES and ERP systems are fully integrated, the enterprise view retrieves WIP data no matter where it is located and no matter how many places store it. Viewing WIP data at the enterprise level not only facilitates compliance, but also assists a company in its inventory and financial planning.

But according to the MESA model, tracking and managing inventory, including WIP data, is MES's responsibility. WIP data need material-identification numbers for the ERP system to track them. Because MES identifies WIP data with its own rules, separate identification numbers in the ERP system could create confusion.

On the other hand, maintaining WIP data at the production level is complicated if the manufacturing process takes place at several plants—particularly if the plants use different MES. This situation would require MES to be standardized.