GxP Lifeline
A Modern Pharma MES Solution Offers the Best of Old and New
Evaluating your production line for efficiency requires visibility points along the line, a way to pull the data you need, and a way to analyze it. You need the right person, at the right time, at the right place; or you can use a modern manufacturing execution system (MES) to do this instead. As soon as you can obtain and analyze production metrics, you can make necessary adjustments to processes, equipment, and materials. Without visibility into production operations, however, you are allowing operational blind spots that can lead to issues such as long lead times, excessive waste, and quality nonconformances.
The Inaccessibility of a Legacy MES
Pharma MES solutions have been available for 20 years. Still, not all pharma manufacturers are able to deploy them across all product lines because they can be cumbersome, expensive, and difficult to implement and use. A legacy MES also lacks modern functionality, including a cloud infrastructure, quality system integration, and the agility necessary for small or single batches, which are becoming more common.
That leaves legacy MES installations accessible to only the high-priority production lines. This makes it more difficult to put quality pharmaceuticals on the market in a timely manner.
What Do Legacy MES Systems Lack?
Traditional manufacturing management systems are marked by several deficiencies:
- Disconnected. Most MES installations are fixed on-site without interconnectivity to other digitized systems such as enterprise resource planning (ERP) systems and quality management systems (QMS).
- Undiscoverable. Data managed within a pharma MES often requires complex analysis, and visibility is limited to on-site personnel. According to Deloitte, “data is the lifeblood of digital transformation” for life sciences companies, implying a company will fail without it. 1 Data that is not visible because it is offline or difficult to interpret is not useful.
- Inefficient. When systems fail to coordinate equipment and production schedules, it invites potential overlaps and interruptions.
- Inflexible. Fixed hardware installations and custom coding prevent manufacturers from reconfiguring the shop floor to meet changing market demands such as for personalized medicines or single-product batches.
What Can a Modern Pharma MES Solution Do?
Manufacturing facilities that perform well are already using paperless, automated processes that speed up production by 50 to 100% 2. Think of a modern pharma MES solution as the slim or sleek version of an MES that more and more manufacturing companies will not be able to do without due to it having the following characteristics:
-
Configurability.
Pharma manufacturing software that’s already set up to match your production processes without requiring custom coding enhances your existing operations rather than forcing you to adapt to new practices. -
Efficiency.
Digital production records and automated workflows foster right-first-time batches. -
Agility.
Fast and flexible responsiveness makes it easier to change production lines and accommodate small batches. -
Real-time visibility.
With a modern pharma MES, data that was previously offline (blind spot) goes online so you can retrieve data as it’s being generated from local and remote locations. -
Review-by-exception capability.
Because production records are automated and support electronic signatures, a modern MES correlates directly with shortened review times and fewer person-hours necessary to complete them.
Modern MES Solutions Are Achievable
A modern MES is crucial to developing high-quality pharmaceutical products and a high-performing organization. Shifting to a modern MES solution is possible with careful consideration, planning, and implementation. It requires a new way of thinking about the complex processes involved in pharma manufacturing and finding technology that codifies best practices. 3
The implementation of a pharma MES solution can be measured in weeks or months — compared with the years it takes for a legacy installation — and it costs much less. This increases both the accessibility and the value of modern MES solutions. By choosing a modern MES, such as MasterControl’s Manufacturing Excellence, you can shift the balance of pharma manufacturing practices in favor of simpler and better.
A Modern MES Enhances Pharma Production Performance
More useful data is a key indicator of effective pharma manufacturing software. Integrated data from various functional aspects of your operation that is accessible through an understandable interface truly brings you closer to manufacturing ideals and allows more timely engagement from more operatives all along the line. 4
You don’t have to wait to find the perfect balance between your current performance and the ideal level of performance you’re striving to achieve.
References:
- “Deloitte Tech Trends 2022 Life Sciences perspective,” Todd Konersmann, 2022
- “Digitization, automation, and online testing: Embracing smart quality control,” Norman Carra, Evgeniya Makarova, Jeff Morell, Matthias Ringel, and Vanya Telpis, McKinsey Apr 14, 2021.
- “Leveraging digital and analytics in biopharma operations: Six principles,” Stephanie Bayer, Sulay Sandy, Ulf Schrader, and Matthias Spiegl, McKinsey, May 27, 2021.
- “Future thoughts about pharmaceutical manufacturing,” Giuseppe Menin, Manufacturing Chemist, Jan 19, 2021
Ave Love is a professional mom of six and content writer for MasterControl. She brings a technical perspective, focused on the usability and accessibility of working solutions. Previously she worked as a technical writer and documentation manager for software development companies that support community infrastructure. She holds a bachelor's degree in comparative literature from Brigham Young University.
