Electronic Batch Records (EBR) Software
Replace paper batch records with guided, error-proof electronic batch records. Accevo EBR guides operators step by step, captures data automatically from machines, and turns batch release from a paper chase into review by exception.
Built for pharma manufacturing and regulated industries: FDA 21 CFR Part 11 and EU GMP Annex 11 compliant, ALCOA+ by design, with validation support under GAMP 5.
What is an electronic batch record (EBR)?
An electronic batch record is the digital version of the batch documentation that regulated manufacturers must keep for every batch produced: materials and quantities used, equipment, process parameters, quality checks, operators and timestamps. An EBR system replaces the paper binder with digital forms filled at the operator panel – partly by the operator, largely automatically from machines and scales.
Each batch record is created from a Master Batch Record (MBR) template that defines every activity, limit and required signature in sequence. The system enforces the workflow, keeps data integrity end to end, and generates the final PDF batch documentation for release. EBR software is the core of paperless production in pharmaceutical, food and cosmetic plants – anywhere batch record software is a regulatory requirement, not a convenience.
Regulatory requirements: FDA 21 CFR Part 11, GMP & EMA
Electronic batch records exist because regulators demand provable control over batch production. Accevo EBR is built to the strictest regime in manufacturing – pharmaceutical GMP and cGMP – so every audit question already has a documented answer.
Company certifications
ISO 9001 – certified quality management across development, delivery and support.
ISO/IEC 27001 – certified information security management; your production data sits under independently audited security controls.
Verify us – certificate copies, scope statements and audit evidence for your supplier qualification, available at any stage of evaluation.
Built-in compliance
FDA 21 CFR Part 11 & EU GMP Annex 11 – secure audit trails, unique user authentication, role-based access and electronic signatures, satisfying both FDA and EMA (EudraLex Volume 4) expectations for electronic records.
ALCOA+ by design – every record Attributable, Legible, Contemporaneous, Original and Accurate, with a full change history that preserves every prior value.
Electronic Batch Records – review-by-exception, enforced workflows and complete batch genealogy for faster release under full GMP compliance.
Validation & change control
GAMP 5 (2nd Edition) alignment – developed and implemented as a configurable product, enabling a risk-based, simplified validation approach.
CSV/CSA support – standard validation documentation packages, requirement traceability and IQ/OQ/PQ execution support.
EBR vs paper batch records
Paper batch records are slow to complete, slower to review, and fragile: missing entries, illegible handwriting and transcription errors are found at release – weeks after the batch was made, when correction is most expensive.
Electronic batch records catch the error at the moment it would happen: the system will not let an operator skip a step, enter an out-of-limit value unnoticed, or use the wrong material. Review starts the second the batch starts.
With paper batch records you get:
- Manual entries, manual calculations, and errors discovered at batch release
- Days of QA review per batch, checking every line of every form
- Archiving rooms full of binders, and slow retrieval during audits
- Traceability reconstructed by hand when a deviation or recall hits
With EBR software you get:
- Automatic data acquisition from machines, scales and sensors - no transcription
- Review by exception: QA looks only at flagged deviations, cutting release time up to 45%
- Complete electronic batch record management with instant search and retrieval
- Full batch genealogy at a click - from raw material to finished good and back
45%
batch release time reduction
60%
less time spent on batch control
5%
fewer errors and deviations
10/10
GMP principles enforced by the system
Key features of Accevo EBR software
Everything needed to run batch production electronically – from MBR template design to the released PDF batch report – in one electronic batch record software platform for EBR manufacturing, designed to be simple for operators: no calculations, no interpretations, only the entries and signatures that matter.
MBR template builder
Model your Master Batch Record with drag-and-drop sections, fields and quality limits. One Generic MBR can serve a whole family of similar products, replacing hundreds of individual templates.
Guided execution & digital forms
The workflow engine guides operators step by step at the panel: to-do lists, instructions with images and video, enforced sequence, and electronic signatures at defined checkpoints.
Automatic data acquisition
Process values, weights and machine data flow into the batch record directly from automation. Forms fill themselves; operators confirm instead of transcribing.
Quality inspections & SPC
Periodic quality tests with immediate in/out-of-limit verdicts, read from automation or entered manually. SPC reports and Shewhart control charts monitor process stability.
Level 3 serialization
Site-level serialization manages serial number flow between packaging lines and the enterprise level – supporting anti-counterfeiting and regulatory compliance in pharma.
PDF batch reports
The system generates the complete batch release documentation as a PDF automatically, with deviation reports and full change history stored and searchable.
Audit trail, traceability & batch genealogy
When an auditor or a deviation asks “what exactly happened with this batch?”, the answer must be complete, attributable and immediate. This is where an EBR system earns its keep.
- Complete audit trail: Every action is recorded: who did what, when, and what changed - with unique user authentication and electronic signatures per FDA 21 CFR Part 11. Records are ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate.
- Full material traceability: Ongoing production is matched with serial numbers, component batches and containers. Scan a finished good to find every raw material in it - or scan a raw material to find every finished good it went into.
- Batch genealogy for faster release: The complete genealogy of every batch - materials, equipment, rooms, people, parameters - is assembled automatically as production runs, so release under review by exception takes hours, not weeks.
Integration with QMS, MES & your enterprise systems
An electronic batch record is only as good as the systems around it. Accevo EBR is a module of one manufacturing platform, and integrates in real time through web services (REST, SOAP), SAP RFC, intermediate databases or flat files.
QMS
Deviations flagged in the batch record flow into the quality management system for CAPA handling, while quality limits defined in QMS govern EBR validation checks.
MES
EBR runs on the same platform as Accevo MES: machine connectivity, OEE, weighing & dispensing and container management share one data model – no interfaces to maintain between them.
ERP & LIMS
Orders, BOMs and routings come in from ERP; production reports, consumption and work logs go back. Lab results from LIMS complete the batch record for release.
eBR in pharmaceutical manufacturing: use cases
Electronic batch records pharma teams rely on cover far more than forms. In pharma manufacturing, the eBR pharmaceutical workflow controls materials, equipment, rooms and people around every batch.
Operator guidance & digital SOPs
Every paper form on the shop floor – work orders, dispensing records, cleaning logs, deviation reports – becomes a digital, enforced workflow inside the batch record.
Weighing & dispensing
Direct integration with scales verifies material identity, weighs against target with tolerance control, and writes the result straight into the electronic batch record.
Container management
Every intermediate container has a digital identity: where it is, what is in it, when it was last cleaned – all linked into the genealogy of the batches it touches.
Rooms management
Before an operator enters a room, the system verifies it is clean, qualified and free of the previous product – and records the verification in the batch record.
Client story:
Validation support: CSV & GAMP 5 from day one
A compliant system you cannot validate is not compliant. Accevo EBR is developed and implemented as a configurable product aligned with GAMP 5 (2nd Edition), and every project includes computer system validation (CSV/CSA) support: standard validation documentation packages, requirement traceability, and documented release and change management. Your validation team gets deliverables, not homework.
Contact with our Expert
Piotr Kańka, Industrial Software Expert
- A 60-minute online meeting with a dedicated specialist presenting a top system from an industry similar to yours
- Live modeling of your production process
- A budget quotation after the meeting
Frequently Asked Questions
Electronic batch records, explained
An electronic batch record is the digital batch documentation regulated manufacturers keep for every batch: materials, equipment, process parameters, quality checks, operators and timestamps. EBR software creates it automatically during production from a Master Batch Record template, enforcing every step and signature.
The Master Batch Record (MBR) is the approved template: the defined sequence of activities, limits and signatures for making a product. The electronic batch record (EBR) is the executed instance - the actual record of one specific batch, created as production runs against the MBR.
Accevo EBR is built for FDA 21 CFR Part 11 and EU GMP Annex 11 (EMA / EudraLex Volume 4): secure audit trails, unique user authentication, role-based access and electronic signatures. Compliance evidence is available for your supplier qualification.
Instead of QA checking every line of every batch record, the system validates each value against specification in real time and flags only deviations. QA reviews the exceptions, not the whole record - which is how customers cut batch release time by up to 45%.
Accevo EBR follows GAMP 5 (2nd Edition) as a configurable product. Projects include computer system validation (CSV/CSA) support: standard validation documentation, requirement traceability matrices, and documented change control - reducing your validation effort to review and approval.
Yes. EBR imports orders, BOMs, routings and employee data from ERP (including SAP via RFC), returns detailed production reports, links deviations to QMS/CAPA, and completes batch records with lab results from LIMS - via REST/SOAP web services, intermediate databases or flat files.
Primarily pharmaceutical and life sciences manufacturing, where GMP and cGMP make batch records mandatory - but also food, beverage and cosmetics plants that need the same traceability, error-proofing and faster batch release without the regulatory obligation.
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