Implementation and Beyond

The road to MES production starts with an initial scope and lifecycle overview. One pressing concern for pharmaceutical manufacturers is the transition to automated production, and how an MES application can increase product standardization and data reliability. To gain a better understanding of MES implementation and lifecycle maintenance, we turned to Rockwell Automation’s Ed Kubiak. Kubiak, a Rockwell MES expert, explained why each phase of MES implementation and maintenance is important to high quality production.

Choosing an MES

The first step to comprehensive and successful automated production is finding the system that works for your company. No company is exactly alike, so no system will be a perfect fit.  Many different MES solutions are available for companies to implement using outside vendors, while some solutions are customized to production processes. Kubiak explained why the difference matters for optimized production, “While no system can be defined as ‘out-of-the-box,’ there are modifiable systems offered by vendors which can be expanded through additional software engineering. Rockwell’s PharmaSuite application does just this, allowing a company to continuously upgrade their additional MES software to meet production needs. While implementing these systems may have a larger implementation cost, overall ease in production changes and lower maintenance costs mean that this solution has a shorter ROI period.”

Systems made specifically for certain production processes, however, may have a longer ROI period due to changing production needs or software updates. Updating a customized MES solution for future production needs will require additional engineering which may increase overall MES costs as opposed to basic software.

When choosing an MES, companies should think about long-term system maintenance and prepare for solution upgrades. Customized systems may need extensive engineering to upgrade or replace altogether. Modified systems, like Rockwell’s PharmaSuite, however, may be easily upgraded, “At Rockwell, our software works primarily through a basic platform, but has the ability to incorporate add-ons. This way, companies are getting high quality manufacturing which matches their production goals and needs while retaining the ability to easily upgrade their basic system.”

Testing and Validating an MES

Testing an MES requires a company to understand their manufacturing needs, and relay those within a User Requirement Specification. This set of guidelines outlines how the company plans to meet those needs. A URS may include system input and output specifications, performance requirements, response times, and many more production details.

Creating a URS with the aid of an outside consultant, or with the help of a vendor, may increase a company’s understanding of specific MES abilities. Kubiak explains, “A clearly defined User Requirement Specification is crucial to successful MES usage. Choosing a vendor who will work with a company to create this URS can give the company and MES end-users a better understanding of MES possibilities. This will help a company leverage as much as they can from their investment.”

Validating an MES varies from one company to the next. Along with a well-defined URS, maintenance goals and needs should be specified before commencing validation testing. This will enable users to quickly recognize unmet goals, unreliability, or any complications with I.T. or data configuration. By recognizing these factors, production managers may determine the need for upgrades or overall replacement of the MES.

Upgrading or Replacing an MES

As previously mentioned, the ease with which a company is able to upgrade or completely replace their MES solution may hinge on the kind of MES they employ. Determining the need for an upgrade or replacement also means determining engineering and ROI costs. Additionally, some factors may indicate an immediate need for these options, “the age of a system may be the easiest way to determine it’s current and future production abilities. A lot of legacy systems will need these engineering efforts. Some vendors, however, will update their basic systems for you. At Rockwell we help companies upgrade their systems by updating our basic software. This will save a company money and time by only upgrading or replacing the additional app suite attached to the software.”

Each company will have its own set list of upgrade criteria, but it is important to remember that outdated systems may not adhere to production compliance or data quality. For this and many reasons, it is important to have a plan in place in the event of an MES upgrade or replacement to quickly and compliantly resume production.

Choosing to automate pharmaceutical and medical device manufacturing can streamline production processes. This optimization can save companies time and money while standardizing product quality and data formation. The initial steps to developing an MES implementation plan must incorporate the full business scope to accurately determine how and when each step should be taken for any specific enterprise. To hear more about manufacturing execution systems from Rockwell Automation, or learn more about MES lifecycle best practices, register for the Pharmaceutical Manufacturing Execution Systems Conference, May 22-23, in San Antonio, TX.