Electronic vs. Paper Batch Records in Supplement Manufacturing

In the dietary supplement industry, maintaining complete, accurate, and secure production records is essential for regulatory compliance and ensuring product quality. These records—referred to as Batch Manufacturing Records (BMRs) or Batch Production Records (BPRs)—are the cornerstone for verifying that each product is manufactured in accordance with established processes and standards. As manufacturing practices evolve and regulatory expectations increase, companies are increasingly considering electronic batch record (eBR) systems to support data consistency, traceability, and operational efficiency [1].

What Is a Batch Manufacturing Record?

A Batch Manufacturing Record is a comprehensive document that captures the complete history of how a specific batch of dietary supplement was made. A BMR typically includes:

• Raw material details: lot numbers, supplier information, and quantities used
• Equipment and tools: machines, balances, and other equipment involved in the process
• Process parameters: weights, times, temperatures, and other critical variables recorded throughout production
• Operator involvement: signatures or initials for each step completed, along with time stamps
• Quality checks: results of in-process and finished product testing, as well as cleaning and changeover records
• Deviation documentation: records of any unexpected events or nonconformances and actions taken

The primary purpose of a BMR is to demonstrate that every batch was manufactured according to approved procedures and specifications, as required by 21 CFR Part 111 and global GMP standards [1,7].

What Is an Electronic Batch Record?

An Electronic Batch Record (eBR) is a digital version of the traditional BMR. eBR systems are designed to capture production data either automatically (direct from equipment or digital scales) or through manual operator input at computer terminals. These systems can guide operators step-by-step through manufacturing instructions, require verification and sign-offs, and flag missing or out-of-specification data before a batch can proceed [2].

eBR systems often include features such as:

• Automated, time-stamped audit trails for all actions and data changes
• Electronic signatures and access controls, supporting compliance with electronic record requirements
• Built-in checks, prompts, or interlocks to reduce the risk of human error or skipped steps
• Searchable digital databases for faster record retrieval and reporting
• Integration with laboratory, quality, or inventory management systems

Many eBR platforms are designed to help manufacturers comply with 21 CFR Part 11 (electronic records and signatures), EMA Annex 11, and similar global guidance [2,4].

Comparing Paper and Electronic Batch Records

Are Electronic Batch Records Required?

Electronic batch records are not a legal requirement for dietary supplement manufacturing in the U.S. or most global jurisdictions. Companies may use either paper or electronic systems, provided they meet all applicable regulatory standards. For example, 21 CFR Part 111 (for dietary supplements), 21 CFR Part 11 (for electronic records and signatures), and general Good Manufacturing Practices (GMP) require that records be accurate, complete, readily retrievable, and available for inspection [1,2,7]. Both paper and electronic systems can meet these requirements if managed properly [3].

Electronic systems can, however, offer advantages in traceability, error prevention, access controls, and record retrieval, and may help organizations demonstrate data integrity in line with current regulatory guidance [5].

Hybrid Systems: Regulatory Cautions and Common Practices

While both paper and electronic batch records are permitted under current regulations, many organizations use “hybrid” systems—a blend of paper and electronic components. This situation often arises when an enterprise resource planning (ERP) system or another digital platform generates batch record templates or work orders that are printed out and filled in by hand on the shop floor. This approach is very common, especially in facilities where digital systems support inventory and production planning but the final execution records remain on paper.

However, hybrid systems present unique challenges for data integrity and compliance. Regulatory authorities such as the World Health Organization (WHO) and the European Medicines Agency (EMA) generally advise against hybrid systems as a long-term solution [3]. Key risks include:

• Data integrity gaps: When records are split between electronic and paper, it can be unclear which record is authoritative. This increases the potential for errors, omissions, and inconsistencies, as well as unauthorized changes or loss of information.
• Audit trail complications: Auditors may struggle to follow the sequence of events if actions are recorded in different formats. Paper portions are more vulnerable to alteration or misfiling, while electronic systems generally have automated audit trails.
• ERP-generated documents: Even when ERP or manufacturing execution systems create controlled templates, once these are printed and completed manually, traceability and version control can become issues—especially if paper is re-copied or annotated by hand.
• Reconciliation burden: Organizations using hybrid approaches must implement robust controls to reconcile all records and ensure every component is complete, up-to-date, and traceable across platforms.
• Regulatory scrutiny: WHO and EMA guidance indicate hybrid systems “present more opportunities for error or data integrity lapses” and recommend that such approaches only be used temporarily, with a clear plan for transition to a fully electronic or fully paper-based workflow [3,4].

Ultimately, facilities employing hybrid systems should be prepared to demonstrate, during audits or inspections, how data from both sources is controlled, reconciled, and protected from loss or tampering. If hybrid systems are necessary during transitions, organizations should develop and document procedures for managing risks and plan for full digital or paper integration in the future.

Transition Considerations

Organizations considering a move from paper to electronic batch records should carefully assess several critical factors before beginning the transition. Key considerations include:

• System design and validation: The eBR solution must be validated to confirm it performs as intended, supports data integrity, and meets applicable regulatory requirements [2].
• Training and user adoption: Operators, quality personnel, and managers require comprehensive training and support to ensure effective use of the new system [5].
• Compatibility with existing equipment and processes: The chosen eBR system should integrate smoothly with current manufacturing, quality, and IT infrastructure.
• Data integrity requirements: Controls should be established to protect against unauthorized data changes, ensure secure electronic signatures, and provide a reliable audit trail [6].
• Long-term accessibility and retention policies: Electronic records must be securely stored and remain accessible for the entire retention period required by regulation or company policy [7].

Successfully implementing an electronic batch record system typically requires careful planning, cross-functional collaboration between production, quality, and IT, and ongoing monitoring to ensure that compliance and operational needs continue to be met [5].

Conclusion

Batch records—whether paper or electronic—are essential for ensuring the integrity of dietary supplement manufacturing. Both approaches are acceptable under U.S. and most international regulations. However, electronic systems can deliver operational efficiencies, improved data integrity, and better support for evolving regulatory expectations. Hybrid systems, while common, require strong controls and present unique compliance challenges. The transition from paper to electronic batch records is a strategic decision that should be guided by a careful assessment of organizational readiness, compliance requirements, and long-term business goals [5].

References

1. U.S. Food and Drug Administration. 21 CFR Part 111 – Current Good Manufacturing Practice for Dietary Supplements.
2. U.S. Food and Drug Administration. 21 CFR Part 11 – Electronic Records; Electronic Signatures.
3. World Health Organization. Technical Report Series No. 996, Annex 5 – Guidance on Good Data and Record Management Practices. 2016.
4. European Medicines Agency. Annex 11 – Computerised Systems. 2011.
5. U.S. Food and Drug Administration. Data Integrity and Compliance With Drug CGMP Questions and Answers – Guidance for Industry. 2018.
6. Pharmaceutical Inspection Co-operation Scheme. PIC/S PI 041-1 – Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. 2021.
7. European Commission. EU EudraLex – Volume 4 – Good Manufacturing Practice Guidelines.