Enhancing Life Sciences Manufacturing With Electronic Batch Production Records

In recent years, manufacturers have invested in digital transformation in manufacturing by digitizing their core information systems, including enterprise resource planning (ERP) and manufacturing execution systems (MES). Yet these investments in technology are too often weakened by critical processes that remain manual, disconnected and often paper-based. Even as manufacturers invest in system digitization and automation, the people responsible for production records have been left to manage paper, spreadsheets and other standalone systems to collect, record and interpret data relating to production and quality processes.

Overcoming Challenges in Life Sciences Manufacturing: The Limitations of Disconnected Production Processes 

Paper-based production processes don’t automatically integrate with electronic interfaces, systems, or processes. When data is offline or only partially digital, it’s disconnected and makes it impossible to analyze and use in context with other cross-functional data. Without connected manufacturing execution software, complete information transfer between systems, end-to-end visibility, and truly meaningful insights are all but impossible.

Even electronic systems, when siloed, don’t sufficiently track data and documents from different areas throughout the production life cycle like integrated electronic production records can. Poor communication between disparate information systems like ERP, MES, and quality management systems (QMS) severely limits the throughput between manufacturing, quality, and other critical business areas, which impedes physical operations. Further, it stifles access to data and the intelligence it could provide.

Companies that don’t undergo complete digital transformation in manufacturing must continue to use paper-based or disconnected systems. These systems offer little communication or interoperability between one another and consequently create information gaps and blind spots and invite preventable errors.

According to a recent report from MasterControl, “The State of Digital Maturity in Pharma and Medtech Manufacturing,” 64% of life sciences manufacturing professionals still struggle with process inefficiencies, siloed production data, missing or unusable data, and compliance issues – all of which can be overcome with modern manufacturing execution software.¹

Driving Digital Transformation in Life Sciences Manufacturing: The Need for Integrated Systems  

According to LNS Research² , executives in manufacturing operations management cite timely visibility into manufacturing performance metrics (25%) along with disparate systems and data sources (20%) as the top two challenges in addressing top manufacturing objectives for life sciences companies. When executives in life sciences industries were asked about their key challenges in quality management, among the top three cited were quality metrics not being measured effectively (26.3%) along with disparate quality systems and data sources (18.4%).

When it comes to digital transformation in manufacturing and quality, LNS Research recommends an integrated network of systems and processes.

“With integrated data and information available across the value chain, life sciences companies have the ability to track the entire lifecycle of information, including raw materials/stock feed coming from suppliers, the production process, and delivery and service to customers,” according to the industry analyst firm. “This end-to-end visibility connects batch and device history records up through enterprise reporting and scheduling systems, allowing organizations to pinpoint and isolate product non-compliances and understand their origin, which is crucial for meeting cGMP compliance.”

MES for Life Sciences: Integrating Manufacturing Execution Software With Core Systems  

To collect, connect, and contextualize the data and information needed to optimize manufacturing and ensure quality throughout the product life cycle, companies can digitally integrate manufacturing execution software, such as MasterControl Manufacturing Excellence, with their ERP, MES, QMS, and other core information systems for a more complete view of the data within their business.

Integration establishes secure and productive connections between enterprise systems, data sources, processes, and people across the value chain, for a holistic view of production and quality data. An integrated electronic production records solution extends – rather than replaces – existing disconnected ERP, MES, or material requirements planning (MRP) systems to the shop floor.

For example, when electronic production records are digitally integrated with an ERP or MRP, operators on the shop floor can input production data directly into tablets and pull materials or work order information directly from the ERP or MRP.

Digitally integrating manufacturing execution software with a QMS lets manufacturers link standard operating procedures (SOPs) and work instructions to an electronic production record to ensure operators always use the correct versions. When necessary, operators can even launch deviations directly from the record. Integration makes possible in-line quality assurance and real-time releases.

In each integration scenario – whether ERP, MRP, MES, or QMS – automatic data-integrity checks with the electronic production record ensure the data is entered completely and correctly.

Optimizing Batch Production Records: Unlocking Performance in Life Sciences Manufacturing

By integrating their enterprise applications with an electronic production record system, manufacturers can reveal data-driven performance insights across the entire production life cycle that otherwise remain hidden. The result is greater quality and productivity improvements that enable manufacturers to ship products faster without compromising quality.

As soon as manufacturers extend digital transformation beyond their core systems to include their production records, they can:

• Improve and preserve data integrity as information moves between systems.
• Capture and share real-time production data across systems and departments seamlessly.
• Enable end-to-end traceability throughout production and beyond.
• Complete production cycles and close production records in rapid time.

To learn more about the evolving trends of digital transformation in manufacturing and where you fit in the digital maturity model, download MasterControl’s complimentary report, “The State of Digital Maturity in Pharma and Medtech Manufacturing.”

References:

1. "The State of Digital Maturity in Pharma and Medtech Manufacturing,” MasterControl, 2023
2. "A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences,” by Matthew Littlefield, Rob Harrison, Mike Roberts and Greg Goodwin. LNS Research.