GxP Lifeline

Four 2019 Manufacturing Batch Record Trends Holding Up in 2020


Early last year, MasterControl published a white paper exploring four trends in manufacturing batch records. As we enter Q3 in 2020, these 2019 trends are remaining relevant.

To avoid becoming overwhelmed by these game-changing advances, experts encourage manufacturers embarking on their digital transformation journey to identify business-critical processes and make strategic, incremental changes in these areas.

“Start the journey with steps that will achieve near-term value, while laying the foundation for new business opportunities that will come from interconnectivity and a broad access to data and information,” said the global chair of KPMG’s Industrial Manufacturing Sector in its recent Global Manufacturing Outlook report (1).

Trend #1: Data Will Drive All Aspects of Manufacturing

Throughout the manufacturing process, life sciences manufacturers capture enormous amounts of data. Much of it is trapped in paper documentation, but now is the time to unlock it through digitization to gain greater access to actionable insights. This topic was explored at length in a recent MasterControl webinar about adopting a data-centric mindset, which emphasizes the competitive advantage of having data that is accessible, searchable, and readily available to inform business decisions. 

Trend #2: New Technology Leads to Process Improvements

One of the logical first steps toward digitization and unlocking insights is adopting the use of electronic batch records (EBRs). Advantages of using EBRs instead of paper-based systems include:

  • Reduction in the number of data entry errors, because data limits are programmed and incorrect entries are rejected by the system.
  • Quicker review times as a result of fewer data entry errors needing to be addressed and having all necessary information in one central location. It’s also possible to conduct a review by exception.
  • Faster time to market, which provides a competitive edge.

Implementing new technology like an EBR solution serves as an opportunity to:

  • Evaluate existing processes and tools.
  • Assess strengths and weaknesses.
  • Determine how the newly acquired technology will change the way work is done.

“Because they’re completely recreating their master templates, it’s an opportunity for them to really look closely at what works and what doesn’t. Process improvement will be big when it comes to batch record execution,” explained Terrance Holbrook, a manufacturing veteran and innovator of manufacturing solutions.

Trend #3: The Human Element in Manufacturing Is Reimagined

There is a fear that technology will replace people in the manufacturing industry. However, there are valuable human traits that can’t be replicated by machines, including judgment, experience, creativity and intuition. Without these qualities on the manufacturing floor, neither manufacturing businesses nor the industry would be successful. As technology like an EBR solution is adopted, workers can stop pushing paper and use their ingenuity to improve the quality of the product.

Trend #4: Truly Paperless Production Becomes a Top Priority

Paper-based batch records are problematic. Regulatory compliance is put in jeopardy because data integrity, traceability and security are all compromised. In mid-2019, GxP inspection analytics firm Govzilla reported data integrity is among the top items cited on U.S. Food and Drug Administration’s (FDA) warning letters. In addition, the FDA cited data integrity on 79% of the drug warning letters over the last five years, and they have increased the number of warning letters citing data integrity by over four times. (2)

Streamline manufacturing processes and protect data integrity by eliminating paper from the shop floor and adopting an EBR solution today. 

  1. “Dare to be Different: It’s time to revamp collaboration in life sciences manufacturing,” by Anne Marie O’Halloran, Barry Heavey and Greg Ciccarelli, Accenture, 2019. https://www.accenture.com/_acnmedia/PDF-98/Accenture-Life-Sciences-Dare-to-Be-Different-Contract-Manufacturing.pdf

  2. “2020 Contract Manufacturing Survey,” by Sean Moloughney, Contract Pharma, 2020. https://www.contractpharma.com/issues/2020-03-01/view_features/2020-contract-manufacturing-survey/

Dale Thompson - Profile Picture

Dale Thompson is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. Her areas of expertise are pharmaceuticals and manufacturing. Thompson’s varied career includes extensive work in grant writing and journalism as well as crafting content to highlight the work of biology professors and paleontologists. She has a bachelor’s degree from Evergreen State College and a master’s degree in professional communication from Westminster College.

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