Industry Case Studies, Life Sciences

Integrating SAP with Shop-Floor Systems to Achieve Compliant Manufacturing

Background:
This leading Pharmaceutical company had just completed the successful conversion of its legacy ERP environment to SAP. Regulatory pressure caused the company to pursue implementation of various business initiatives, such as Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR). These initiatives were being led by the customer but were largely staffed by a third party services company. As such, this key Life-Science developer was looking for an integrated ERP to shop-floor solution for their manufacturing systems.

Situation:
The customer's primary need was for a detailed review of overall manufacturing operations and the systems and technology environment, leading to a recommendation for the future state SAP-to-shop-floor systems design along with a plan of action to achieve it. EnteGreat had previously worked with the client on a training engagement to transfer knowledge on MES and process modeling, and because of the rapport established during the initial training sessions, the client decided to apply EnteGreat's manufacturing and systems integration expertise to the overall project. The client was concerned with whether or not the solution being implemented by the third-party services company would actually permit effective connectivity to the shop-floor in later program phases. EnteGreat was brought in to leverage its expertise with SAP-to-shop-floor integration projects.

Solution:
The primary objectives of this project were to develop a holistic system integration architecture and to establish a roadmap for effective long-term system design and risk management. EnteGreat guided the client's systems personnel in the definition of an overall SAP-to-shop-floor systems integration that fit their overall business needs and specific short-term project requirements, as well as their long-term strategic directions. EnteGreat's scope of work included development of a future state systems integration architecture showing production areas, networking connections and segmentation, and applications that supported standardized connectivity from critical elements of the manufacturing environment to SAP.

In addition, EnteGreat improved overall project efficiencies through the creation of a clear, understandable definition for shop-floor processes and data, based on an international industry standard. These models helped streamline project development through eliminating rework and enabling designers and developers to implement their technical objects in less time. Because of their scope and structure, the models also became part of the basis for the client's internal change management program.

Benefits:
EnteGreat's contributions to the project gave the client the confidence to move forward with their manufacturing systems integration program without fear of overlooking critical operational and technical factors. Through the course of the project, the client came to realize that applying a process-centric model to an SAP-to-shop floor integration project is a key factor in reducing implementation risk, decreasing project duration, and increasing project quality. The manufacturing systems architecture defined specific mechanisms for identifying the shop-floor devices that needed to be connected to SAP, and identified the optimum methods for accomplishing those connections. The results established both long-term implementation flexibility as well as a modularized systems validation compliance strategy. Throughout this project, EnteGreat was able to reduce overall project costs by eliminating or deferring various unnecessary or low-priority architectural and software elements.