ASG has been involved in several medical device projects from product inception through requirements specification, design, the review process, debugging and testing, 501K submission, clinical trials, and product validation. To a great extent we can provide help at the systems and engineering management levels as well, codifying pertinent documentation and developing standards, test procedures, and other documents as required by the regulatory process. ASG generally acts as an adjunct to your existing engineering resources, especially for those companies that do not have significant software development expertise in an FDA-regulated development environment.
In the pharmaceutical manufacturing environment ASG can provide expertise in manufacturing control and e-signature (21 CFR 11) applications. We can also provide independent verification and validation (IV&V) where corporate policy or the FDA demands it.
The Instrumentation Society of America (ISA) claims that when done correctly, MES systems: · Reduce work in process by 20% · Reduce plant efficiency/downtime by 30% · Reduce manual data entry time by 75% · Reduce waste by 15% The return on investment can therefore be pretty short, measured in months. Until a system is fully operational, however, it's difficult to gauge just what the practical savings will be. We believe that any application that provides improved automation and more/better/faster data into the hands of the decision makers will, in the long run, also improve the corporate bottom line.
ASG works primarily with the GE Proficy product line. We have also worked with the Siemens/Rockwell and Wonderware (formerly Microsoft Navision) offerings.
There are dozens of MES software development companies; many (like SAP) regard MES as an adjunct to their larger Enterprise Resource Planning (ERP) systems. The MESA International website is a good place to start when looking for MES vendors.
The most typical uses that ASG has observed are for historical data collection, visualization through digital dashboards and nearly real-time reporting, management of machine down time, and management of employee utilization. Of these, downtime awareness is probably the biggest reason for purchasing an MES system.
Manufacturing optimization has become a key to growth and, in many cases, survivability. MES systems, when properly designed, help to reduce waste, improve machine and employee utilization and minimize raw material and product inventories. They also provide additional insight to strategic decision-makers with regard to upgrades, maintenance and capital improvements.
MES systems provide computerized control of manufacturing processes. In this regard they are similar to SCADA and DCS systems (see the FAQ on SCADA and Controls). MES systems tend to provide the "middle ground" between lower-level SCADA operations (which tend to be more limited to individual machines or manufacturing lines) and plant-wide DCS systems (which tend to provide all-encompassing control of a very large manufacturing system or an entire plant). MES systems' popularity stems from the application's focus on providing information about plant utilization and efficiency. Through a combination of historical data collection, real-time operations and operator inputs, MES systems deliver information about manufacturing efficiency, use of raw materials, product yields, operator efficiency, down/idle time and other parameters that help streamline plant operations.