Electronic Batch Record (EBR)

This topic is part of the SG Systems Global MES, GMP data integrity & batch documentation glossary.

Updated December 2025 • Batch Manufacturing Record (BMR), Electronic Batch Record System, MES, Batch Review by Exception (BRBE), Data Integrity, 21 CFR Part 11, EU Annex 11

Electronic Batch Record (EBR) is the digital, structured version of your batch manufacturing record – the “story of the batch” captured as data instead of pen scratches. It’s the complete, contemporaneous record of how a specific batch was made: what was done, by whom, with which materials, on which equipment, using which parameters and checks, and with which deviations and decisions. Done well, an EBR is a truthful movie of the batch with timestamps and context; done badly, it’s just a scanned paper packet with a fancy name.

“If your ‘EBR’ is a PDF of a hand-filled form, you don’t have electronic batch records – you have digital fossils.”

1) What Is an Electronic Batch Record?

An Electronic Batch Record is the complete, official record of how a given batch was manufactured, captured and stored electronically rather than on paper. At minimum, it contains:

• link to the master batch record / recipe used (version, effective date),
• identification of the batch (IDs, product, strength/variant, campaign info),
• materials and components actually used (lots, quantities, statuses),
• equipment used and line/room identifications,
• step-by-step execution data (start/stop times, parameters, readings, IPC results),
• operator and supervisor e-signatures, including reviews and approvals,
• deviations, comments, overrides and related CAPA references,
• yields, reconciliations and final disposition (released/rejected/quarantined).

In a real eBR, most of this is generated automatically as the batch runs – from MES, devices and integrated systems – not reconstructed afterwards from memory and scraps of paper.

2) Electronic Batch Record vs Paper BMR vs eBatch “Scans”

Three things that often get conflated:

• Paper BMR/BPR: Handwritten or manually completed batch records on paper forms. GMP-acceptable, but fragile in terms of legibility, completeness, review efficiency and data integrity.
• Scanned batch records: Paper completed, then scanned to PDF or image. More accessible storage, but still fundamentally manual and unstructured.
• True Electronic Batch Record (EBR): Data captured electronically at the time of execution, with audit trails, structured fields, enforced flows and e-signatures in a validated system.

Scans are not EBRs. They are just a different format of the same manual record – with all the same data integrity risks (late entries, overwrites, illegible writing, missing steps) plus the joys of searching PDFs when something goes wrong.

3) What Makes an EBR “Good” (and Defensible)?

A defensible EBR does more than tick “electronic” on a checkbox. It should:

• Be contemporaneous: Entries made at (or very close to) the time of action; system timestamps and sequencing support this.
• Be attributable: Every entry is linked to a unique user with appropriate access and, where needed, e-signature.
• Be complete: No unexplained gaps, missing readings, skipped steps or half-filled sections.
• Be accurate & consistent: Values reflect reality; checks and calculations (for example, sums, reconciliations) are reliable.
• Be traceable: Clear links to materials, equipment, deviations, CAPAs, QC results and release decisions.
• Be reviewable: QA can navigate through the record, understand what happened and focus on exceptions rather than retyping data into Excel.
• Be enduring & secure: Stored in a validated, backed-up system with controlled access and tamper-evident audit trails.

If any of those elements are weak, you might be technically “electronic” but you’re not really solving the core GMP documentation problem – and inspectors will see that quickly.

4) EBR Content & Structure

Although layouts differ, most EBRs follow a consistent backbone:

• Header & identification: Product, batch ID, strength, dosage form, recipe version, site, manufacturing dates.
• Material sections: Pre-populated list of expected materials with fields for actual lots, quantities, statuses, expiry checks and verification signatures.
• Equipment & environment: Equipment IDs, status (calibrated, clean, line clearance), room/area data and environmental readings if relevant.
• Process steps: Each operation (dispensing, charging, mixing, reacting, filtering, filling, packaging) with instructions, parameters, target ranges, recorded values and in-process tests.
• Exceptions & comments: Structured space to capture deviations, alarms, manual interventions, justifications.
• Yield & reconciliation: Input vs output, scrap, rework, product and material balances.
• Review & approval: Operator checks, supervisor oversight and QA release/reject documentation.

The difference between a good and bad EBR layout is usually whether it reflects the process flow operators and QA actually think in – or whether it’s just a digital photocopy of a form designed decades ago.

5) EBR, Data Integrity & 21 CFR Part 11 / Annex 11

Because EBRs are core GMP records, they sit directly under:

• 21 CFR Part 11: requiring validated systems, secure, time-stamped audit trails, controlled user accounts, unique e-signatures, and clear linkages between signatures and records.
• EU Annex 11: requiring fitness-for-purpose, documented requirements, risk-based validation, change control and regular system review.
• Data integrity expectations: ALCOA+, periodic system/data reviews, detection of unusual editing patterns, business rules that minimize opportunities for manipulation.

An EBR that allows silent overwriting, modification of historic data without trace, or shared logins is a direct data-integrity violation. A well-designed EBR implementation, by contrast, can be your strongest data-integrity control: no missing entries, no backdated scribbles, no mystery corrections with “see me” notes in the margin.

6) EBR vs Electronic Batch Record System vs MES

Simple way to think about the stack:

• EBR: The record – the electronic, GMP-significant output for a specific batch.
• Electronic Batch Record System: The platform that orchestrates execution and generates EBRs (templates, workflows, device integrations, storage).
• MES: The broader execution layer that usually contains the EBR system plus scheduling, OEE, material management, etc.

You can have MES functions with limited eBR (for example, only weigh & dispense), or a niche eBR system without full MES scheduling and performance features. In practice, regulated sites increasingly converge to MES-based eBRS, because separating execution and batch records too much creates painful integration and validation problems.

7) What an EBR Means for V5

On the V5 platform, Electronic Batch Records are the natural output of how V5 MES, V5 QMS, V5 WMS and V5 Connect API cooperate on one data model – not a separate “eBR module” floating off to the side.

• Execution and capture – V5 MES
  • V5 MES executes master recipes and digital work instructions for each batch, capturing operator actions, times, parameters and IPC results directly into the EBR.
  • Equipment interfaces (scales, PLCs, PAT sensors, printers) feed data straight into the record, reducing manual entry and transcription errors.
  • Deviations, comments and holds can be raised from within the MES screens, automatically linking to the EBR and V5 QMS.
• Quality context – V5 QMS
  • Controlled master batch record templates live in V5 QMS and feed V5 MES, ensuring EBR content reflects approved procedures and specifications.
  • Deviations, nonconformances, OOS and CAPA opened from an EBR are managed in V5 QMS, but remain linked to the originating batch and its data.
  • QA review workflows and electronic release/reject decisions are recorded in V5 QMS and visible inside the EBR view.
• Materials & genealogy – V5 WMS
  • Material picks and consumptions recorded in V5 WMS populate the “materials used” sections of the EBR – with lot, quantity, status and expiry information.
  • Finished product from an EBR (batch/lot IDs, quantities, QA status) flows back into V5 WMS so inventory and traceability align with batch outcomes.
  • Full genealogy from raw material to finished lot to shipment is available by drilling from the EBR through WMS history.
• Integration – V5 Connect API
  • Pulls in lab results from LIMS, linking stability and release assays to the relevant EBRs.
  • Syncs batch IDs, material codes and product data with ERP, PLM or CRM so EBRs can be referenced in finance, design and customer-facing processes.
  • Supports external sites/CMOs where portions of EBR data must be exchanged securely and consistently.

Net effect: an EBR on V5 is not “a file someone uploads”. It is the live, assembled view of data coming from execution, quality, warehouse and external systems, all sitting on one validated platform and object model.

8) Implementation Roadmap & Practice Tips for EBR

Moving from paper or pseudo-electronic records to EBR is as much about batch design and QA habits as it is about software. A pragmatic route:

• 1. Choose a pilot product/line. Ideally one with enough complexity to matter and enough volume to pay off, but not the single most fragile process you own.
• 2. Rationalise the paper BMR first. Remove redundant fields, clarify instructions, fix known pain points. The best eBRs start from a cleaned-up logic, not a direct clone of a clumsy BMR.
• 3. Design the “story of the batch”. Work with operators and QA to define the key events, decisions and data points the EBR must show. Then build V5 MES workflows around that story rather than shoehorning steps into legacy form layouts.
• 4. Integrate at least the critical devices. If you’re still hand-typing weights, temperatures or counts that could come electronically, you’re undermining both integrity and efficiency.
• 5. Build QA review views early. Configure EBR summaries and exception lists that QA will actually use. If review is painful in the pilot, adoption will be slow everywhere else.
• 6. Validate with risk in mind. Focus testing effort on execution logic, data capture, audit trails and signature controls. Treat each integration according to its impact on GMP data, not all as equal.
• 7. Train with real scenarios. Use past deviations, common errors and tricky batches as training examples in the new EBR environment, not just “happy path” runs.
• 8. Stop running dual systems as soon as it’s safe. Parallel paper + EBR for a short time if you must, but plan a hard cutover to avoid divergence and confusion about the “real” record.
• 9. Measure and broadcast benefits. Track RFT documentation, review cycle time, documentation-related deviations and investigation times. Use the improvements to justify rolling EBR across more products and sites.

The aim is straightforward: every batch tells a clean, electronic story that QA and regulators can read and trust without detective work – and that story is assembled automatically from how the plant actually runs on V5.

FAQ

Q1. Is a PDF export from MES or SCADA automatically an EBR?
Not necessarily. A true EBR is a complete, validated, GMP-significant record with proper structure, audit trails, e-signatures and links to relevant events and systems. A PDF export can be part of that, but the underlying system and process must meet data integrity and completeness expectations. A random PDF dump of some process values is not, by itself, an acceptable EBR.

Q2. Do regulators require EBRs, or is paper still acceptable?
Regulators generally still accept well-run paper batch records, especially at smaller sites. However, expectations around data integrity, review efficiency, CPV and global oversight are steadily pushing industry towards EBR. Many large customers, corporate groups and inspectors now see a credible EBR implementation as a strong sign of maturity – and heavy reliance on paper as a growing risk.

Q3. What is the difference between an “eBMR” and “EBR”?
In practice, the terms are often used interchangeably. Some organisations use “eBMR” (electronic Batch Manufacturing Record) for the full record aligned with the master batch record structure, and “EBR” for a more generic electronic batch record. The key point is that both refer to the electronic, GMP-significant batch records; the exact acronym matters less than the actual content and integrity.

Q4. How does an EBR support Batch Review by Exception?
Because data in an EBR is structured, time-stamped and checked against rules during execution, the system can generate a list of exceptions – parameter excursions, missing or late entries, deviations, failed IPCs – automatically. QA can then focus review on those exceptions while sampling or spot-checking the rest, instead of line-by-line manual verification of everything. This is only credible when your EBR templates and rules are robust and your system enforcement is strong.

Q5. How do we handle attachments (charts, scans, lab reports) within an EBR?
Ideally, critical data from lab systems and instruments should be integrated as structured fields via LIMS or device interfaces. When that is not possible, scans or file attachments can be linked to specific steps or sections in the EBR, with appropriate metadata and audit trails. Those links, and any manual transcription from attachments into structured data, must be covered by your validation and data integrity controls.

Related Reading
• Batch Documentation: Batch Manufacturing Record (BMR) | Electronic Batch Record System | Batch Review by Exception (BRBE)
• Execution & Integrity: MES – Manufacturing Execution System | Digital Work Instructions | Data Integrity | 21 CFR Part 11 | EU Annex 11
• Systems & V5 Platform: V5 Solution Overview | V5 MES – Manufacturing Execution System | V5 QMS – Quality Management System | V5 WMS – Warehouse Management System | V5 Connect API