GxP Lifeline

How to Solve 3 Common Batch Record Challenges


Life sciences manufacturers' production processes should be assets, and not create challenges. Yet too many manufacturing companies allow their batch records to become liabilities by using manual, often paper-based systems that are error-prone, disconnected, and limited in the operational insights they provide.

Below are three common batch record challenges manufacturers encounter and some practical ways an electronic batch record (EBR) solution can resolve them.

#1: Poor Data Integrity

Relying on manual, paper-based processes to collect, manage, and review batch manufacturing records inevitably leads to poor data integrity, which creates issues that can spread through production and slow everything down. When every step of the batch record process is conducted manually and on paper, the entire process is slow, cumbersome, and prone to error. Common snags that delay manual batch operations include:

  • Scribal errors
  • Illegible entries
  • Incorrect values
  • Incomplete forms
  • Missing signatures
  • Record sent to the wrong reviewer

The accumulation of the errors and omissions in paper-based batch operations, together with the constant checking and rechecking required with manually conducted processes, delays product release.

An EBR solution can eliminate human error with automatic data integrity checks and real-time data corrections and verifications. Capturing data completely and accurately the first time streamlines the batch record process. And with an EBR system that has review-by-exception functionality, all that needs to be reviewed after production are steps that didn’t go as planned. By conducting a review by exception, it’s possible to shorten review times from weeks or days to hours.

#2: Disconnected Data

In paper-based or only partially digitized systems, you’re working with disconnected data because information is trapped in paper or legacy systems, which complicates reporting, trending, and analysis. Paper-based batch record processes don’t easily integrate with electronic systems or other quality manufacturing processes, making complete data transfer all but impossible. Partially digitized batch record processes also perpetuate offline silos and disconnected data sources.

An EBR solution can improve visibility of, and access to, production and quality data by creating dynamic connections between core systems, including:

  • Enterprise resource planning (ERP)
  • Material requirements planning (MRP)
  • Manufacturing execution system (MES)
  • Quality management system (QMS)
  • Laboratory information management system (LIMS)
  • Learning management system (LMS)
  • Supervisory control and data acquisition (SCADA)

For example, by digitally integrating batch manufacturing records with a QMS, manufacturers can link standard operating procedures (SOPs) and work instructions to the batch record to ensure operators always use the correct, current versions. It also means operators are able to launch deviations directly from the EBR to ensure in-line quality assurance. Automatically storing EBRs in a QMS further eliminates having to manually route paper records from the shop floor to the quality department.

#3: Insufficient Tracking

Manufacturers that rely on manual, paper-based batch record processes have insufficient tracking abilities, which limit how well they can track manufacturing changes, identify quality events, and take corrective action in real time. Limited tracking information practically ensures the occurrence of bottlenecks.

For example, manual production processes often lead to poor tracking and control of deviations, including slow detection of necessary deviations and high occurrence of in-process deviations. Limited awareness of these and other quality events makes it difficult to reduce preventable deviations and their impact while causing delays in corrective actions, quality review, and product release.

An EBR solution with analytics and in-process dashboards can provide real-time operational visibility and optimization, enabling manufacturers to:

  • Gain real-time work-in-progress visibility and traceability into the status of production lines, batches, lots, and operator performance.
  • Integrate the recording, assessment, and approval of all deviations throughout the manufacturing process with real-time deviation-tracking tools.
  • Connect EBRs with enterprise systems to seamlessly exchange data, increase data accuracy, and gain a complete picture of production data.

With a fully connected EBR solution, it becomes possible for manufacturers to eliminate preventable errors before they spread, unlock previously hidden data, and better understand how their shop floor is working. In short, digitizing production processes with an EBR solution empowers manufacturers to resolve some of the most common batch record challenges.


David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a content marketing specialist at MasterControl, he previously served as editor of Thomas Publishing’s Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.

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