Electronic Batch Records (EBRs): Definition, Example, Transition to EBRs, and Software

An Electronic Batch Record (EBR) is a digital version of a batch record used to document every step of manufacturing in regulated life science industries like pharmaceuticals, biotechnology, and medical devices.

The main goal of EBRs is to digitally manage and document the production and quality control processes in manufacturing environments. EBRs help ensure that all documentation is accurate, complete, and compliant with regulatory requirements such as Good Manufacturing Practice (GMP), FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, and other relevant standards.

EBRs capture production data, material usage, operator actions, test results, and deviations in a structured, time-stamped, and traceable format, thereby improving data integrity and compliance.

An example of an EBR typically includes sections such as batch identification, master batch reference, raw material usage, process instructions, in-process controls, deviation records, final yield, and audit trails, all digitally structured for ease of access and auditability.

Regulatory requirements for EBRs are outlined by standards like GMP, EU GMP Annex 11, FDA 21 CFR Parts 11 and 820, ISO 13485, and ICH Q10. These requirements emphasize data integrity, audit trails, user access control, electronic signatures, and comprehensive documentation throughout the product lifecycle.

Related terms often used interchangeably with EBR include Batch Master Records (BMRs), Batch Production Records (BPRs), and Device History Records (DHRs). EBRs provide manufacturers with secure, efficient, and regulatory-aligned batch documentation that enhances traceability and operational efficiency.  By replacing manual systems, EBRs foster a culture of quality, compliance, and continuous improvement in modern manufacturing environments.

SimplerQMS offers integrated EBR management functionality within its quality management software. Features include Batch Master Record (BMR) configuration, data input, deviation management, and automated review and approval workflows. The platform supports regulatory compliance, end-to-end traceability, and enhanced audit readiness.

Book a personalized demo with SimplerQMS to see how our integrated EBR and QMS solution can support your organization’s compliance and efficiency goals.

What Is an Electronic Batch Record (EBR)?

An Electronic Batch Record (EBR) is a digital version of a batch record used to document and retain detailed information about batch production activities in regulated life science sectors such as pharmaceuticals, biotechnology, and medical devices.

The primary goal of Electronic Batch Records is to digitally manage, monitor, and document all aspects of the manufacturing and quality control processes in manufacturing environments.

To maintain compliance, EBR systems are designed to meet the requirements of key regulatory frameworks, including Good Manufacturing Practice (GMP), FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 and others.

By maintaining contemporaneous, accurate, and verifiable records, EBRs support data integrity and streamline batch review and approval processes. EBRs also provide documented evidence that each batch has been manufactured in accordance with approved procedures and quality requirements.

Key differences between EBRs and paper batch records are outlined below.

• Data Entry: EBRs use streamlined digital input, while paper records rely on manual handwriting.
• Validation: EBRs can allow real-time data validation during entry, reducing the need for manual review and minimizing errors. In contrast, paper records typically require separate, manual validation after data entry.
• Signatures: Digital signatures in EBRs ensure secure and traceable approvals, while paper records require wet signatures.
• Workflow Management: EBRs help maintain consistency in documentation practices by reducing variability often seen with paper-based processes.
• Access to Records: EBRs provide centralized, real-time access to documentation, whereas paper records are stored physically and are harder to retrieve.
• Audit Trail: EBRs automatically generate complete, tamper-evident audit trails while paper audit logs must be managed manually.
• Review and Approval: EBRs accelerate and streamline the review process, while paper systems are typically slower and more error-prone.

Several terms are used interchangeably with Electronic Batch Records or refer to specific types of batch-related documentation.

• Electronic Batch Master Records (eBMRs)
• Electronic Batch Production Records (eBPRs)
• Electronic Batch Formula Records
• Electronic Batch Packaging Records
• Electronic Device History Record (eDHR)

What Are the Benefits of Electronic Batch Records?

Electronic Batch Records offer numerous benefits, and some of the key ones are outlined below.

• Improved Data Accuracy: EBRs can help reduce human error by minimizing manual data entry and ensuring more consistent, legible, and complete batch documentation compared to paper records.
• Enhanced Compliance: EBRs support compliance with GMP, FDA 21 CFR Part 11, EU GMP Annex 11, GxP, ISO 13485, and FDA 21 CFR Part 820. Built-in audit trails, electronic signatures, and secure data handling help ensure regulatory compliance.
• Increased Efficiency and Productivity: EBRs eliminate manual paperwork and streamline workflows, enabling staff to focus on value-adding tasks instead of administrative duties.
• Reduced Batch Release Cycle Time: Digital review and approval processes shorten the time required for batch release, helping manufacturers accelerate product availability.
• Reduced Operational Costs: Transitioning to EBRs helps reduce material waste, rework, and manual labor, contributing to long-term cost savings.
• Improved Traceability and Audit Readiness: EBRs automatically log every action, creating a tamper-evident audit trail that simplifies inspections and supports audit readiness.
• Enhanced Continuous Improvement: Access to historical batch data allows manufacturers to identify trends, analyze deviations, and drive process optimization for ongoing quality improvement.

What Is an Electronic Batch Record Example?

An Electronic Batch Record example typically consists of a structured digital form that guides operators and quality personnel through the complete batch manufacturing process. EBRs capture production data, quality checks, approvals, and deviations in a standardized, compliant, and easily auditable format.

Electronic Batch Records generally include the sections listed below.

• Batch Identification Details: Includes batch number, product code, production date, lot size, and manufacturing site information.
• Master Batch Record Reference: Indicates the version-controlled MBR template that governs the batch process steps.
• Process Instructions and Checklists: Step-by-step manufacturing procedures with mandatory operator inputs such as checkboxes, fields, or dropdown selections.
• Raw Material and Component Usage: Details the materials used, including supplier, lot number, quantity, and usage verification.
• Equipment Logs and Calibration Checks: Confirms that all equipment involved in production is properly calibrated and maintained.
• In-Process Controls and Results: Records measurements, such as weights, volumes, and other process-critical parameters with defined acceptance criteria.
• Deviations and Non-Conformance Records: Captures process deviations and links them to CAPA actions or quality investigations.
• Electronic Signatures and Approvals: All entries and approvals are documented using secure, timestamped digital signatures, which are applied during the final approval step.
• Final Yield and Reconciliation: Summarizes final quantities, yields, and material reconciliation before batch release.
• Audit Trail Summary: Provides a log of all actions taken within the record, including timestamps and user identifiers, ensuring full traceability.
• Batch Approval: Presents a checklist for quality assurance review, deviation closure status, reconciliation checks, and confirmation of completed manufacturing steps.
• Batch Release: Records the final release decision confirming the batch is approved for the next stage or market distribution.

What Are the Regulatory Requirements for Electronic Batch Records?

Electronic Batch Records are subject to several international regulatory frameworks that define how electronic records and manufacturing data should be documented, maintained, and controlled in life science industries.

Key regulatory requirements are listed below.

• Good Manufacturing Practice (GMP): Requires accurate, complete, and traceable batch documentation to ensure consistent product quality and regulatory compliance.
• EU GMP Annex 11: Outlines expectations for computerized systems, focusing on validation, data integrity, access control, and auditability.
• FDA 21 CFR Part 11: Establishes requirements for electronic records and electronic signatures, including secure access, audit trails, and documented evidence of record authenticity and integrity.
• FDA 21 CFR Part 820: Covers quality system regulations for medical devices, requiring complete device history records and documented evidence of production and process controls.
• ISO 13485: Specifies requirements for a quality management system for medical devices, including documented evidence of manufacturing processes, traceability, and product realization.
• ICH Q10: Highlights the importance of accurate and compliant documentation across the pharmaceutical product lifecycle to support process control and continuous improvement.

GMP and EBR Requirements

Good Manufacturing Practice (GMP) establishes a set of quality assurance principles that ensure pharmaceutical and life science products are consistently manufactured and controlled to meet established requirements.

In the context of Electronic Batch Records, GMP compliance requires real-time documentation, meaning data must be captured at the moment each manufacturing activity occurs. This ensures that records are contemporaneous, complete, and accurate, providing traceability and confirming that procedures were properly followed.

EBRs support GMP by providing structured, time-stamped documentation of every activity performed during batch production. This includes capturing process data, recording material usage, logging operator actions, and documenting any deviations or exceptions. The traceability and integrity of this documentation help confirm that each batch was produced in accordance with approved instructions, ensuring product safety, quality, and efficacy.

By integrating these capabilities, EBR systems help manufacturers comply with cGMP requirements and demonstrate that each batch of product was produced according to approved specifications and quality standards.

EU GMP Annex 11 builds upon general GMP requirements by specifying expectations for computerized systems and electronic records within the European regulations. Annex 11 principles focus on data integrity, traceability, and secure access. These principles are widely applied across life sciences to ensure compliant, transparent, and audit-ready electronic data management throughout its lifecycle.

In compliance with EU GMP Annex 11, EBRs should include tamper-evident audit trails, clearly defined user access controls, backup procedures, and documentation that remains legible and available for the entire retention period. Annex 11 also requires a risk-based approach to managing electronic documentation, requiring organizations to assess and control potential risks that may impact record accuracy or completeness.

Together, GMP and Annex 11 define essential requirements for how EBRs should be created, maintained, and reviewed in regulated environments, ensuring that all records are trustworthy, complete, and acceptable for regulatory inspection.

FDA 21 CFR Part 11

Title 21 of the Code of Federal Regulations (CFR) Part 11 is a U.S. FDA regulation that governs the use of electronic records and electronic signatures in FDA-regulated industries.

In the context of Electronic Batch Records, FDA 21 CFR Part 11 requires that records be trustworthy, reliable, and equivalent to paper records. EBRs should include tamper-evident audit trails that capture all actions and modifications in a time-stamped format, ensuring a complete and reviewable history of changes.

Access to EBRs should be restricted to authorized individuals, with each action traceable to a specific user. Records must also incorporate electronic signatures that are unique, time-stamped, and securely linked to the corresponding entries.

These requirements ensure the integrity of electronic records, maintain accountability, and support compliance with FDA 21 CFR Part 11 requirements for electronic documentation in regulated manufacturing environments.

FDA 21 CFR Part 820

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), outlines current good manufacturing practice (cGMP) requirements that medical device manufacturers must follow to market their products in the United States. FDA 21 CFR Part 820 sets the standards for the required QMS, governing essential aspects such as design, manufacturing, packaging, labeling, and documentation.

In the context of Electronic Batch Records, FDA 21 CFR Part 820 emphasizes the importance of controlled documentation, data integrity, and traceability throughout the manufacturing process. EBRs should be used to capture and maintain Device History Records (DHRs), including details such as production dates, quantities, equipment used, and the personnel responsible for each activity.

To support compliance with 21 CFR Part 820, EBRs should enable real-time documentation of each manufacturing step, with clear linkage to the applicable Device Master Record (DMR). Records should reflect the proper execution of procedures, document in-process and final inspections, and include the identity of individuals performing and approving each operation. Updates to EBR content should follow formal change control procedures to ensure that only approved and current documentation is used.

Maintaining accurate and verifiable EBRs helps demonstrate that each medical device was manufactured in accordance with approved specifications, supporting both product quality and regulatory compliance.

ISO 13485

ISO 13485:2016 is an international standard that defines quality management system (QMS) requirements for medical device manufacturers and related service providers. ISO 13485:2016 emphasizes risk management, documentation control, and process validation across all stages of the product lifecycle.

In the context of Electronic Batch Records (EBRs), ISO 13485:2016 compliance involves maintaining accurate, controlled, and traceable documentation of manufacturing activities and quality control measures. EBRs should be treated as official quality records and follow established procedures for review, approval, version control, and retention.

To support ISO 13485 compliance, EBRs should capture manufacturing activities contemporaneously, provide a traceable audit trail of changes, and be reviewed and approved by authorized personnel. Records related to nonconformities, corrective actions, and process monitoring should be documented and traceable within the EBR to demonstrate product quality and regulatory compliance throughout the manufacturing process.

ICH Q10

ICH Q10 – Pharmaceutical Quality System is a guideline developed by the International Council for Harmonisation (ICH) that promotes a harmonized approach to quality management systems across the pharmaceutical industry. ICH Q10 builds upon GMP principles and integrates quality risk management and continuous improvement throughout the product lifecycle.

In the context of Electronic Batch Records (EBRs), ICH Q10 emphasizes the importance of robust and traceable documentation to support product realization, change management, and CAPA processes. EBRs should be used to document each manufacturing step accurately, record deviations, and capture investigations in a structured and timely manner.

To align with ICH Q10, EBRs should support ongoing process performance monitoring and product quality evaluation. Documentation should be complete, consistent, and accessible to enable trend analysis and informed decision-making. EBRs should also reflect outcomes from quality reviews, change control processes, and continuous improvement activities, helping to maintain a state of control across the product lifecycle.

What Are the Technical Requirements for Electronic Batch Records?

Electronic Batch Records need to fulfill several technical requirements to ensure system reliability, regulatory compliance, data integrity, and operational efficiency in life science manufacturing environments.

Below are the key technical requirements for implementing an effective EBR system.

• Access Authorization and Traceability (FDA 21 CFR Part 11.10(d); EU GMP Annex 11 Section 12; FDA 21 CFR Part 820.40(b)): EBRs should be accessible only to authorized personnel. Each entry or modification should be traceable to an individual use, to ensure accountability and reduce the risk of unauthorized changes.
• Electronic Signatures (FDA 21 CFR Part 11.100; EU GMP Annex 11 Section 14; FDA 21 CFR Part 820.180): Electronic signatures applied to EBRs should be legally binding, uniquely attributable to the individual, and equivalent to handwritten signatures on paper records.
• Audit Trails (FDA 21 CFR Part 11.10(e); EU GMP Annex 11 Section 9; GxP Guidelines): EBRs should include secure, time-stamped audit trails that document the creation, modification, or deletion of data. Audit trails are recommended to retain original entries and remain available for review.
• Data Integrity and ALCOA+ Compliance (GxP Guidelines; EU GMP Annex 11 Section 4; FDA 21 CFR Part 820.180): All data recorded in EBRs should comply with ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
• Document Control and Change Management (ISO 13485:2016 Section 4.2.4; FDA 21 CFR Part 820.40): EBRs should be controlled documents with documented version history. Any changes are recommended to be reviewed, approved, and recorded, including the rationale and the identification of the authorizing personnel.
• Legibility and Permanence (FDA 21 CFR Part 820.180; EU GMP Annex 11 Section 7): EBRs should remain readable and maintain their integrity throughout the defined retention period. Data should be accessible and human-readable across its lifecycle.
• Record Availability and Retention: (FDA 21 CFR Part 11.10(c); FDA 21 CFR Part 820.180; EU GMP Annex 11 Section 17): EBRs should be readily retrievable for the duration of their required retention period. They are expected to be available for inspection by regulatory authorities upon request.
• Linkage to Production Data: (FDA 21 CFR Part 820.181; ISO 13485:2016 Section 7.5.1): Each EBR should be linked to the applicable production data and include all executed production steps, deviations, signatures, and test results.
• Review and Approval Documentation: (FDA 21 CFR Part 820.80(d); ISO 13485:2016 Section 8.2.6): EBRs should document the review and approval of batch production, including acceptance criteria, disposition decisions, and the identities of reviewers and approvers.

How to Transition from Paper-Based to Electronic Batch Records?

To transition from paper-based or hybrid batch record systems to fully electronic Batch Records (EBRs), organizations need a structured and strategic approach. This transition—whether complete or incremental—must prioritize regulatory compliance, enhance process efficiency, and ensure successful user adoption.

Below is a step-by-step guide to help you implement EBRs effectively and set the foundation for long-term success.

1. Assess Your Current State: Evaluate existing batch record processes to identify inefficiencies, data integrity issues, compliance gaps, and manual documentation bottlenecks.
2. Define Clear Objectives: Establish measurable goals for transitioning to EBRs, such as reducing documentation errors, shortening batch review timelines, or strengthening traceability.
3. Gather Input from Key Personnel: Involve personnel from relevant areas of the organization to align the implementation with quality, technical, and regulatory requirements.
4. Align Documentation with Regulatory Requirements: Ensure batch record templates and processes align with applicable standards and regulations (e.g., GMP, FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, etc.).
5. Perform a Gap Analysis: Identify discrepancies between current batch documentation practices and regulatory expectations for digital records. Adjust workflows, templates, and data collection methods as needed.
6. Design MBRs: Create standardized, clear MBRs that reflect actual manufacturing processes and conform to internal SOPs.
7. Establish Review and Approval Procedures: Define how batch records will be reviewed and approved, with clear responsibilities and timelines to maintain compliance and efficiency.
8. Train Users: Provide role-specific training to all users, such as operators, reviewers, and approvers. Effective training helps ensure that users can follow the new procedures confidently and compliantly.
9. Run a Pilot or Controlled Rollout: Launch a small-scale implementation to gather user feedback and make necessary improvements.
10. Go Live: Transition fully to the new EBR approach in a controlled manner. Ensure that all users are informed, prepared, and supported. Monitor critical workflows during the go-live phase to maintain compliance and prevent disruptions.
11. Monitor Performance and Continuously Improve: After implementation, monitor documentation performance regularly. Address issues, collect feedback, and implement improvements to maintain long-term efficiency, compliance, and data integrity.

Starting with Electronic Batch Records from the outset, rather than relying on paper or hybrid systems, can help organizations avoid added complexity and compliance risks. It also reduces the resource demands typically associated with transitioning to a fully digital system later on.

What Are the Additional Considerations for EBR Implementation?

Transitioning from paper-based batch records to electronic documentation requires thoughtful planning and awareness of several key considerations. Understanding these factors can help organizations better prepare for a successful EBR implementation.

Find below additional considerations for EBR implementation.

• Initial Preparation and Documentation Workload: Shifting to electronic documentation involves updating existing batch records, aligning data formats with production processes, and ensuring documentation meets regulatory standards. While this requires effort, it lays a solid foundation for long-term efficiency and consistency.
• Data Integrity During Migration: When transitioning from paper or hybrid systems, organizations should take steps to protect data integrity, completeness, and historical accuracy. Validation and cross-checking during migration help maintain confidence in the records.
• Training on Recordkeeping Practices: All personnel involved in creating, reviewing, or approving batch records should receive role-specific training on digital documentation management. This ensures accuracy and reduces the likelihood of documentation errors.
• Change Control in Documentation: Updates to batch templates or records should follow structured review and approval procedures. Proper change control promotes consistency and ensures regulatory requirements are met.
• Retention and Retrieval Requirements: EBRs must remain readable, accessible, and complete throughout the required retention period. Organizations should plan for long-term storage and retrieval, considering future changes in formats or technology.
• Cybersecurity and Confidentiality: As digital records may be sensitive, it is important to apply appropriate safeguards such as access controls and data protection measures to prevent unauthorized access or modification.
• Digital Documentation Expertise: Organizations unfamiliar with regulatory requirements related to digital documentation practices can benefit from expert support. This helps ensure compliant record structures, workflows, and approval processes are in place from the beginning.
• Scalability and Future Needs: When planning an EBR implementation, it is helpful to consider future growth and potential system integration needs. A scalable approach enables organizations to expand capabilities over time while maintaining consistency and control.

What Is Electronic Batch Record (EBR) Software?

Electronic Batch Record software is a digital solution designed to manage and document the execution of manufacturing batch records across regulated industries. EBR software replaces traditional paper-based batch records with validated electronic workflows, improving accuracy, traceability, and compliance throughout the production process.

EBR software guides production operators through step-by-step instructions based on predefined manufacturing processes or Master Batch Records (MBRs). EBR software captures data, enforces adherence to standard operating procedures (SOPs), and ensures comprehensive documentation of the entire production process.

Key functionalities of Electronic Batch Record software include the following features.

• Master Batch Record (MBR) Configuration: Define and manage version-controlled templates that standardize production steps, materials, and quality checks.
• Real-Time Data Capture: Collect production data directly from operators or integrated systems during manufacturing activities.
• Built-In Validations and Alerts: Enforce data accuracy through automated checks that flag missing, inconsistent, or out-of-spec entries.
• Electronic Signatures and Audit Trails: Securely capture approvals with time-stamped, role-based signatures and maintain tamper-evident logs of all system activity.
• Deviation and Concession Management: Trigger and document deviations or quality events, with links to CAPA or investigation workflows when integrated with QMS.
• Review, Approval, and Batch Release Management: Digitally manage review and sign-off processes, enabling faster and more compliant batch release decisions.
• Secure Record Archival: Store completed records with full traceability to support audits and long-term regulatory compliance.

EBR software solutions vary by scope, functionality, and level of integration. The following categories represent the most common types of EBR solutions.

• Standalone EBR Software: Focused solely on digital batch record management, these systems are often adopted by larger manufacturers that require robust batch documentation capabilities. Standalone solutions can be deployed either in the cloud or on-premises, depending on organizational needs and IT infrastructure.
• MES-Integrated EBR Solutions: Built into Manufacturing Execution Systems (MES), these solutions manage batch records as part of a broader end-to-end digital manufacturing process. This integration supports real-time production tracking, process enforcement, and traceability.
• QMS-Integrated Platforms: EBR functionality may also be included as part of a larger Quality Management System. Integrated eQMS platforms enable centralized compliance, document control, and production oversight. For example, SimplerQMS offers an integrated QMS modules that enable unified compliance, document control, and production oversight within a single platform. In some cases, integrated eQMS solutions may also integrate with standalone EBR software.
• Custom Enterprise Software Solutions: Designed for large-scale manufacturers with complex requirements, these solutions are typically customized to support multi-site operations, detailed workflows, and integration with various enterprise systems such as ERP, MES, QMS, and others.

What Is the Role of QMS Software in EBR Implementation?

Quality Management System (QMS) software plays a pivotal role in supporting the successful implementation of Electronic Batch Records, particularly within regulated life science industries.

QMS software enhances quality processes that directly intersect with EBR documentation. Events such as deviations, corrective and preventive actions (CAPAs), and change control procedures can be managed more effectively when connected to batch records through an integrated QMS. This alignment improves traceability, reduces documentation gaps, and streamlines investigations.

Integrating QMS software with an EBR management capability strengthens compliance by ensuring that all related documentation, such as SOPs, Master Batch Records (MBRs), and training records, is version-controlled and linked to relevant user roles. This centralized approach supports faster, more reliable audits, batch reviews, and product release decisions.

Key QMS functions that align closely with EBR needs include deviation management, CAPA workflows, change management, training management, and document control. These QMS modules help enforce procedural compliance and close the loop between production events and quality oversight.

SimplerQMS offers QMS software for life science companies, including the ability to manage Electronic Batch Records alongside broader quality management processes. Beyond EBRs, SimplerQMS supports comprehensive quality management system (QMS) workflows, including audit management, risk assessments, supplier quality, training, and more. These capabilities help organizations maintain compliance with ISO standards, FDA regulations, EU MDR, and other requirements.

Book a personalized demo today to see how SimplerQMS can support your EBR implementation and broader quality management objectives.