Electronic Batch Record System

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

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

Electronic Batch Record System is what you get when you stop treating batch records as a pile of paper to be filled and signed, and start treating them as a live execution and data platform. It’s the combination of MES, e-signatures, automation interfaces and structured workflows that guides operators through a batch, captures every critical action and parameter in real time and then hands QA a reviewable record with built-in checks instead of a stack of handwriting to decipher. Done well, an electronic batch record system (eBRS) turns “reviewing” into actually analysing exceptions. Done badly, it’s just a glorified PDF of the same messy batch record you had before – plus licence fees.

“If your ‘electronic batch record system’ still needs QA to chase missing times, decipher handwriting and phone operators to ask what really happened, you don’t have eBR – you have expensive stationery.”

1) What Is an Electronic Batch Record System?

An Electronic Batch Record System is the set of software components that:

• turn the master recipe / MMR/DMR into executable, step-by-step electronic instructions,
• guide operators through those steps on terminals or tablets,
• pull data from scales, PLCs, sensors, PAT tools and lab systems,
• enforce limits, checks and e-signatures,
• and generate a complete, reviewable batch record at the end – with every required field, calculation and timestamp captured automatically.

In most modern plants, the core of an eBRS is a Manufacturing Execution System (MES) with eBR capabilities, integrated with quality, lab and warehouse systems. The point is not just “going paperless”; it’s turning batch records from historical artefacts into real-time control and evidence.

2) Electronic Batch Record vs Electronic Batch Record System

The terms get mashed together; they’re not the same thing:

• Electronic Batch Record (eBR/eBMR): The actual record for a specific batch – the electronic equivalent of a BMR, containing instructions executed, materials used, parameters, results, signatures and deviations.
• Electronic Batch Record System: The platform that creates, executes and stores those eBRs – recipes, workflows, user interfaces, device integrations, audit trails and reporting.

You can, in theory, have eBRs without a full system (for example, filling in PDF forms on a tablet), but that gives you almost none of the control and data integrity benefits. A real eBRS doesn’t just record what people type; it orchestrates what people do and what equipment does during the batch.

3) Why an Electronic Batch Record System Matters

Moving to an electronic batch record system is not primarily about aesthetics; it’s about:

• Data integrity: Enforcing ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) a lot more reliably than pen and paper.
• Right-first-time: Preventing deviations by enforcing sequences, limits and checks at the point of work.
• Review cycle time: Enabling Batch Review by Exception instead of re-reading every line of every batch.
• Visibility: Letting production, QA, planning and management see batch status, holds and exceptions in real time.
• Standardisation: Ensuring all lines and sites execute the same process logic for a product, not home-grown interpretations of paper MBRs.
• Analytics & CPV: Making parameter trends, yields, deviations and near misses accessible for CPV, QRM and continuous improvement.

In regulated manufacturing, “we still use paper batch records for everything” is increasingly code for “we’re one inspection or recall away from a painful wake-up call”.

4) Regulatory Expectations: Part 11, Annex 11 & GMP

Electronic batch record systems sit squarely under:

• 21 CFR Part 11: US requirements for electronic records and signatures – validation, audit trails, security, record retention and signature linking.
• EU Annex 11: Expectations for computerised systems, including fitness-for-purpose, risk-based validation and data integrity.
• Core GMPs (211, EU GMP Part I, WHO GMP, etc.): Batch records must be complete, contemporaneous, legible, accurate, and retained; systems must be validated; changes controlled; and any limitations or failures appropriately mitigated.

An eBRS that isn’t validated, doesn’t have proper audit trails or lets people alter records without trace will cause more trouble than paper ever did. Conversely, a well-implemented eBRS, integrated with QMS, is one of the strongest data-integrity stories you can tell during an inspection.

5) Core Capabilities of an Electronic Batch Record System

Different vendors use different labels; real systems tend to include:

• Master recipe / MBR authoring: Electronic design of batch templates – steps, parameters, limits, materials, equipment, checks, branching logic and e-signature requirements.
• Electronic execution UI: Operator-facing screens that present instructions, capture data and enforce sequencing at stations, terminals or mobile devices.
• Device & system integration: Connections to scales, sensors, PLCs/DCS, PAT, LIMS and label/serialization systems to pull or push data.
• Exception & deviation capture: Structured mechanisms for recording deviations, comments, overrides and unplanned events, routed into the QMS.
• E-signatures & security: Role-based access, identity management and signature controls that meet Part 11/Annex 11.
• Review & release workflows: QA review, verification, approval and electronic release with clear visibility of exceptions and outstanding investigations.
• Reporting & analytics: Tools to slice batch data by product, line, operator, supplier, shift, failure mode, etc.

Systems that only replicate the layout of a paper BMR on a screen without real logic, integration or exception handling are missing the point – and most of the value.

6) Batch Review by Exception (BRBE) and eBRS

A true electronic batch record system is the only serious way to achieve Batch Review by Exception without playing regulatory roulette. BRBE means:

• rules and limits are embedded in the eBRS – not just in SOPs – so the system can identify exceptions automatically,
• in-limit, in-sequence, correctly executed steps can be reviewed at a higher level of abstraction,
• QA focuses time and brainpower on deviations, borderline events, data trends and non-standard interventions.

Without a robust eBRS, “review by exception” usually degenerates into “we skim everything and hope we spot the bad bits”. Regulators have seen this; the more complex your processes and data, the less credible that approach looks without system support.

7) Common Failure Modes in Electronic Batch Record Implementations

eBRS projects are famous for going sideways when treated as IT deployments instead of operations + QA transformations. Classic pitfalls:

• “Screen-shotting” the paper BMR: Copying the form layout into screens but leaving process logic, calculations and checks manual.
• Under-integrating equipment: Leaving operators to hand-enter weights, temperatures or counts that already exist in controllers – inviting transcription errors and lost automation value.
• Over-complicating templates: Trying to encode every conceivable scenario in one “mega recipe” instead of designing maintainable, modular templates.
• Ignoring QA needs: Focusing on operator UX and forgetting that QA must review exceptions, links to deviations/CAPAs and regulatory critical data paths.
• No link to QMS: Deviation and CAPA handling still done in email or a separate system, breaking the traceability chain from exception to root cause to fix.
• Weak validation narrative: Technical testing done, but no clear “intended use” story tied to data integrity and business risk.

A healthy eBRS project feels like a joint MES–QA–Operations redesign of how batches run and are proven, not just a “paper to screen” lift-and-shift.

8) What an Electronic Batch Record System Means for V5

In the V5 ecosystem, the electronic batch record system is essentially the way V5 MES + V5 QMS + V5 WMS + V5 Connect API work together on a single data model – rather than a separate “eBR module” bolted on the side.

• V5 Solution Overview
  • Defines shared objects – products, formulas, batches, lots, equipment, tests, users, deviations – which eBR templates and records refer to directly.
  • Provides the architectural context for eBR: recipes and batch records are just views of the same underlying manufacturing and quality data.
• V5 MES – Manufacturing Execution System
  • Is the core of the electronic batch record system: it executes recipes, presents digital work instructions, collects in-process data and enforces sequencing, limits and signatures.
  • Integrates with scales, PLCs, PAT, printers and scanners so critical data flows directly into the eBR rather than via manual entry.
  • Captures exceptions and operator comments at the point of work, linking them to deviations and CAPAs in V5 QMS.
  • Generates structured eBRs/eBMRs ready for Batch Review by Exception.
• V5 QMS – Quality Management System
  • Holds master batch record templates, controlled instructions and specifications that V5 MES uses to drive execution.
  • Manages deviations, nonconformances, OOS and CAPA triggered by eBR exceptions, closing the loop between execution and systemic improvement.
  • Provides QA review and approval workflows for batches, including electronic release tied to defined criteria and risk-based rules.
• V5 WMS – Warehouse Management System
  • Feeds the eBRS with correct material and lot selections at each step, enforcing status, expiry and segregation rules in line with the batch record.
  • Receives back the finished batch IDs and quality statuses from eBR execution so inventory reflects real batch outcomes (released, on hold, rejected).
  • Supports full lot and batch genealogy, making it easy to trace deviations and complaints back to specific eBR instances and their data.
• V5 Connect API
  • Connects LIMS, ERP, PLM, CRM and external partner systems so lab results, orders, specifications and complaints can be reflected in batch records and vice versa.
  • Supports data exchange with CMOs and external sites where V5 is used as the sponsor’s eBR view, even if the partner runs a different MES locally.

In that sense, “Electronic Batch Record System on V5” isn’t a separate box – it is the way the V5 stack behaves when configured for GMP: execution (MES), inventory (WMS), quality (QMS) and integration (Connect) all aligned around the same batch record logic.

9) Implementation Roadmap & Practice Tips

Moving from paper or semi-digital batch records to a real eBRS is a big shift. A pragmatic path:

• 1. Pick one value stream. Choose a representative, high-impact product or family (not the simplest, not the hairiest). Map the current paper batch record, deviations and QA review pain points.
• 2. Clean up the master batch record on paper first. Simplify steps, remove redundant fields, clarify instructions. Don’t digitise chaos.
• 3. Design execution flows, not forms. Focus on operator journey, checks, data flows and exceptions. Then design V5 MES recipes and screens around that, not as one-to-one images of the old BMR.
• 4. Integrate the obvious devices. At minimum, integrate key scales, counters and critical sensors. Each manual transcription you remove is one future deviation you never have to investigate.
• 5. Wire to QMS and WMS from day one. Make sure deviations opened from eBR populate in V5 QMS with context, and that V5 WMS respects batch status coming from QA release.
• 6. Validate based on intended use. Use a risk-based validation approach focused on data integrity, signature control and critical process logic, not on every cosmetic UI detail.
• 7. Pilot, then tighten. Run side-by-side with paper for a few batches if regulators or internal comfort require it, then consciously cut over and remove paper to avoid dual systems drifting.
• 8. Measure and sell the wins. Track reduction in RFT errors, review cycle time, deviation rates and QA overtime. Use those numbers to justify expanding eBRS to more products and sites.
• 9. Treat recipes and eBR templates as master data. Put them under strict change control, with impacts on QRM, validation and training fully considered – they are the new heart of your batch control story.

The end game is straightforward to describe: every batch is executed under guided, validated control; every critical action and parameter is captured in context; QA spends its time on the handful of things that went off the happy path; and when regulators or customers ask “show us what happened”, the eBR and its linked records tell the story cleanly without detective work.

FAQ

Q1. Is scanning paper batch records to PDF an electronic batch record system?
No. Scanned paper gives you electronic copies of batch records, but not an electronic batch record system. You still have manual data entry, unstructured fields, weak data integrity and no real-time control. An eBRS orchestrates execution, captures data as it happens and enforces rules; scanned PDFs do none of that.

Q2. Do we have to adopt a full MES to get an electronic batch record system?
Not necessarily, but MES is the most common and robust foundation. Some plants start with lighter eBR tools or workflow engines, then move to MES when they need deeper integration and control. In V5, the eBRS capability is built into V5 MES, so you’re not bolting separate tools together and hoping they behave.

Q3. How does an eBRS help with data integrity expectations?
An eBRS can enforce contemporaneous entry, unique user identities, e-signatures, tamper-evident audit trails, automated capture from instruments, consistent calculations and controlled changes to templates. All of these reduce the risk of missing, altered or backdated entries and make it much easier to demonstrate ALCOA+ compliance to inspectors.

Q4. Can we still use paper for some steps within an electronic batch record system?
Technically yes, especially during transition, but every hybrid step adds complexity and risk. If you must keep paper for certain operations (for example, external labs, manual logs), build clear interfaces: scan or key-enter data into defined eBR fields, link to images, and treat those bridges as part of your validation and data-integrity story. Over time, most organisations aim to reduce paper islands to the minimum possible.

Q5. How do we know if our electronic batch record system is delivering value?
Practical indicators include: fewer RFT issues and documentation errors; reduced QA review time; fewer “missing data” deviations; better visibility of in-process exceptions; easier, faster investigations; and more CPV/QRM decisions based on actual batch data rather than anecdotes. If, after implementation, your QA team still spends the same hours doing the same manual checks, your eBRS is under-configured or under-used.

Related Reading
• Batch Records & Control: Batch Manufacturing Record (BMR) | Electronic Batch Record (eBMR) | Batch Review by Exception (BRBE)
• Execution & Data: MES – Manufacturing Execution System | Digital Work Instructions | SPC | Data Integrity
• Systems & V5 Platform: V5 Solution Overview | V5 MES – Manufacturing Execution System | V5 QMS – Quality Management System | V5 WMS – Warehouse Management System | V5 Connect API