Connecting New York's Bio/Med Industry

How Electronic Production Records Can Extend Manufacturers’ Digital Edge

In recent years, manufacturers have invested in 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 activities. 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.

Paper-based production processes don’t automatically integrate with electronic interfaces, systems or processes, so 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. That means 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. 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.

Simply put, paper-based or disconnected systems that offer little communication or interoperability between one another create information gaps, blind spots and preventable errors. As manufacturers collect data from production and other areas, the data remains siloed due to digital gaps between paper or disconnected systems, stifling access to and analysis of the data and the intelligence it could provide.

Digitizing Beyond Manufacturers’ Core Systems: Connectivity, Visibility and Data Integrity

According to LNS Research¹, 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 both quality and manufacturing, 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.”

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 their production record processes with their ERP, MES, QMS and other core information systems for a more complete view of the data within their business.

With a digital solution like MasterControl Manufacturing Excellence, manufacturers can create productive connections between enterprise systems, data sources, processes and people across the value chain, for a holistic view of production and quality data. The solution extends – rather than replaces – existing, disconnected ERP, MES or MRP systems to the shop floor.

For example, when 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 production records with an MES means manufacturers can also share materials information between the MES and the production record. Digitally integrating production records with a QMS lets manufacturers link standard operating procedures (SOPs) and work instructions to the production record to ensure operators always use the correct versions and launch deviations directly from the record to ensure in-line quality assurance.

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

By extending digitization beyond their core systems to their production records, manufacturers 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.

By integrating their disconnected enterprise applications with a fully digital production record system, manufacturers can close the digital gap that has kept hidden data-driven performance insights across the entire production life cycle. The result is greater quality and productivity improvements so that manufacturers can ship products faster without compromising quality.