5 Ways to Eliminate Batch Record Hassles in Life Sciences Manufacturing

In March of 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to a pharmaceutical company, citing a number of infractions — most notably being the failure to investigate batch discrepancies. For pharma and biotech manufacturers, managing 100-plus–page paper batch records is literally a handful. It opens you up to a wide range of good manufacturing practice (GMP) compliance risks and mishaps (i.e., entry errors, lost or inaccurate data, smudged signatures, contamination events, etc.).

Paper batch records are a notorious source of aggravation in regulated manufacturing. After countless iterations of reviewing, fixing, redoing, and re-reviewing batch records to maintain compliance with FDA and European Medicines Agency (EMA) requirements, life sciences companies are eagerly embracing electronic batch records (EBRs).

Leading pharmaceutical, biotech, and medical device manufacturers that implement EBR software boost production metrics almost immediately — while reducing errors, waste, and operating costs in their cGMP operations. For a deeper dive, our industry brief "5 Must-Haves for Electronic Batch Records" examines modern EBR technologies and provides tips for selecting the right system for your validated manufacturing environment.

Download the Industry Brief: 5 Must-Haves for Electronic Batch Records.

It's Time to Forego the Paper and Opt for Electronic Batch Records

The frustration of paper batch records is reason enough to deploy an electronic system, but there's more. Documentation errors can cost life sciences companies \$5,000-\$10,000 per incident, in some cases reaching \$100,000 or more.¹ For manufacturers of biologics and personalized cell therapies, documentation delays aren't just costly—they can prevent patients from receiving life-saving treatments.

Quality assurance teams often wrestle with batch records totaling 400-500 pages and containing up to 3,000 manual entry points—each a potential deviation or out of specification (OOS) result waiting to happen. No surprise that 64% of life sciences professionals report missing or unusable data with paper-based processes², making real-time decision-making impossible and potentially delaying product release.

Modern EBRs: Key to Optimizing Batch Records

Today's EBRs aren't just paper-on-glass. They transform your 100+-page cGMP batch records into tablet-based workflows that simplify and streamline every aspect of manufacturing while maintaining full data integrity. When selecting an EBR solution for your pharmaceutical, biotech, or medical device operation, look for these five key features that'll revolutionize your operations:

1. Manufacturing EBR Workflow Optimization

Your passion for GMP quality deserves better tools. Look for solutions that automatically track and store data electronically, collect information directly on the production line, and connect standard operating procedures (SOPs), training, and specs in real time—all while maintaining 21 CFR Part 11 compliance and satisfying EU Annex 11 requirements.

2. Connected Manufacturing Systems

Integration is everything in modern pharma manufacturing. Your EBR should seamlessly connect with the rest of your enterprise tech stack such as enterprise resource planning (ERP) systems, learning information management systems (LIMS), manufacturing execution systems (MES), and quality management systems (QMS). This connectivity shares data across departments in real time, giving you streamlined tech transfer and augmented visibility that paper simply can't match.

3. Complete and Usable EBR Data

Your ultimate goal is to achieve fully integrated quality. A dependable EBR solution will allow you to capture both structured and unstructured data across departments, ensuring ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) principles are maintained throughout. By eliminating data integrity issues before they impact production, you're building quality into every step of your manufacturing process.

4. Timely Product Reviews and Releases

Higher throughput. Fewer headaches. Look for solutions that automate review and release processes, adapt quickly to changes in manufacturing approaches, and reduce lead times for product batches. One cellular therapeutics developer cut batch review time by 50% with EBRs, getting critical therapies to patients faster.³

5. In-Depth Manufacturing Traceability

No more needle-in-haystack searches for records during FDA inspections. With just a few clicks of a mouse, modern EBR solutions can provide real-time, searchable information across all manufacturing phases. Trace raw material suppliers, process changes, deviations, and potential risks instantly—crucial capabilities for maintaining compliance and responding confidently to regulators' requests.

These are just a few of the advantages of implementing EBRs in your life sciences manufacturing operation. Ready to transform your compliance and production efficiency?

Download the Industry Brief: 5 Must-Haves for Electronic Batch Records.

References:

1. Analysis based on customer feedback from MasterControl prospects and customers.
2. "The State of Digital Maturity in Pharma and Medtech Manufacturing," MasterControl research report.
3. "Dendreon: Where Quality and Manufacturing Share a Common Goal," MasterControl case study.