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Background

Over the past 5 years, many forward thinking companies have invested in Manufacturing Execution Systems (MES) to enable electronic Batch Records (Bio/Pharma industry) and Medical Device History Records (Medical Device industry). As these systems are built out, a logical integration point is between the MES and the CMMS. The desire for linking asset information usually maintained in your CMMS directly with the MES is compelling.

Avoiding FDA 483’s

In examination of a recent FDA 483 which resulted in a production shut down at a major pharmaceutical manufacturer, the lack of ability to trace particular equipment use to a drug production lot was a major finding. This was uncovered in an examination of Corrective Action event (CAPA) that erroneously stated the traceability.

Purpose built CMMS’s for Life Science have the ability to track not only calibration and maintenance of equipment, but the equipment’s production usage as well. This combined data provides a great resource in building a compliant Batch Record or Device History record.

MES Use In Life Science Manufacturing

MES implementations have become prevalent enough in pharmaceutical and Biotech manufacturing there is an industry conference dedicated to the subject. This year is CBI’s 7th Annual MES in Life Sciences Conference to will be held in August of 2012 and it features a session dedicated to MES integration.

Top 5 Reasons To Integrate

Here’s a quick list of the top reasons to integrate your CMMS with your MES:

  1. Prevent Operators from Using Inappropriate Equipment – by linking the live status of the equipment to your MES you can prevent unintended use.
  2. Build a more complete Electronic Batch Record/Device History – By including not only live status, but asset history information your Batch Record/Device History record will be more complete and accurate.
  3. Track and communicate Equipment Changes Which Effect the Process – with Change Control being pushed to the point of activity, the CMMS typically contains the most current information on changes that could affect quality
  4. Measure Overall Equipment Effectiveness (OEE) – the use of Key Performance Indicators such as OEE has increased.  It is a way to measure the productivity of manufacturing and the information contained in the CMMS combined with the Production data of the MES enables it.
  5. It’s a Simple Integration – Software system integrations can be time consuming and lengthy, but integrating a CMMS with and MES is one of the simplest.  It is usually a “one way” pull of data from the CMMS to the MES and can be accomplished by of the shelf functionality in the MES and simple report views and SQL statements into the CMMS

As more companies are driving productivity and compliance gains, integration of your CMMS and MES make a compelling business case with a fast Return On In Investment.

For more on Blue Mountain Integration capabilities please check out our Professional Services page.