Examples
Worked examples
- Is an instance
A drug product manufacturer runs a Manufacturing Execution System (MES) that generates a batch-specific record from the validated Master Production Record, prompts operators through each processing step in sequence, time-stamps every entry, requires a second qualified person to electronically countersign checks required under 21 CFR 211.188(b)(11), and locks completed sections against undocumented edits.
- Is an instance
A contract manufacturer producing an investigational biologic for a Phase 2 trial records raw-material lot numbers, in-process results, and any deviations for that batch in its EBR system, and the completed electronic record -- not a paper printout -- is the batch record produced during an FDA pre-approval inspection.
Counter-examples
Looks similar, but isn't
- Not an instance
A site completes a paper batch record by hand and later scans it to PDF for storage or email -- the scanned image is a digital copy of a paper record, not an EBR, because the system that generated it was never validated as a Part 11 electronic-records system and the paper original remains the GMP record of record.
- Not an instance
An informal spreadsheet used to log which operator ran a manufacturing step, with no audit trail, access controls, or system validation, does not meet 21 CFR Part 11's definition of a controlled electronic record even though it exists only in electronic form.
Editorial commentary
Electronic Batch Record (EBR) is the electronic-system equivalent of a paper batch record used in GMP-regulated drug, biologic, and device manufacturing. It is the record that documents, for one specific manufactured batch, that each step of the validated Master Production Record was executed — by whom (or by which qualified automated equipment), when, with which materials and quantities, and with what in-process results — captured and retained in a system that satisfies 21 CFR Part 11‘s controls for electronic records because it is being used, electronically, to satisfy an existing Good Manufacturing Practice (GMP) record-keeping requirement.
The regulatory basis
In the United States, the underlying record-keeping obligation comes from current Good Manufacturing Practice (cGMP) for finished pharmaceuticals, 21 CFR Part 211, specifically 21 CFR 211.188, “Batch production and control records,” which requires a complete record for every batch showing that each significant manufacturing step was performed and, where applicable, checked by a second qualified person. 21 CFR 211.68, “Automatic, mechanical, and electronic equipment,” is the provision that specifically permits computerized and automated systems to be used to perform and document these steps, including allowing validated automated equipment to satisfy the “second person checks” requirement under 211.188(b)(11) when a qualified person confirms the equipment performed correctly.
Once a manufacturer chooses to keep the batch record electronically rather than on paper, 21 CFR Part 11 governs the electronic record itself: the system must be validated for its intended use, generate a secure, time-stamped, computer-generated audit trail that independently records operator entries and changes, restrict access to authorized individuals, and use electronic signatures that are uniquely attributable to the signer. A record only functions as a true EBR — rather than a digital image of a paper record — when the system producing and retaining it meets those controls. Outside the US, the equivalent expectations sit in EU GMP Annex 11 (computerised systems) alongside the core batch-record requirements in EU GMP Chapter 4.
Master Production Record vs. Batch Production Record
An EBR system typically distinguishes two linked documents:
- Master Production Record (MPR) — the validated, version-controlled template for how a given product is to be manufactured: the formula, the sequence of steps, in-process controls, and acceptance criteria that apply to every batch of that product.
- Batch Production Record (BPR) — the batch-specific instance generated from the MPR for one actual manufacturing run: the specific lot numbers, quantities, operator entries, timestamps, in-process test results, and any deviations recorded as that particular batch was made.
In a paper system these are two physical documents. In an EBR system, the software generates the batch-specific record from the approved master template and walks operators through it step by step, which is also how EBR systems enforce sequence (a step can’t be skipped or performed out of order) in a way a paper form cannot.
EBR vs. paper batch records
The practical differences that matter for compliance and audit readiness:
- Real-time error prevention. An EBR can require a field to be completed, a value to fall within a validated range, or a prior step to be signed off before allowing the next step to proceed — a paper form cannot enforce any of this at the point of data entry.
- Independent audit trail. Part 11 requires the audit trail to be system-generated and independent of the operator, capturing who changed what, when, and (for a correction) why — distinct from an operator simply initialing a strike-through on paper.
- Review by exception. Because deviations and out-of-range entries are flagged automatically, quality reviewers can focus review effort on the exceptions an EBR surfaces rather than re-reading every line of every batch record, which is the main efficiency case manufacturers cite for adopting EBR/MES systems.
- What it does not do. Digitizing a batch record does not, by itself, satisfy Part 11 — a scanned PDF of a hand-completed paper form is a digital image, not an electronic record under Part 11, because the system that produced it was not validated to generate and control the record electronically in the first place. See the counter-example below.
Where EBR shows up in clinical research administration
Research administrators and CRAs most often encounter EBR indirectly, through investigational product (IP/IMP) manufacturing and supply for a clinical trial. A sponsor or contract manufacturer producing an investigational drug or biologic for a trial documents that manufacturing run in a batch record — increasingly an EBR — and that record is part of what an FDA inspector or a trial sponsor’s quality group can request during an inspection or audit of the manufacturing site, alongside the site’s own trial documentation. Understanding what an EBR is, and that it is a manufacturing-quality artifact governed by GMP and Part 11 rather than a clinical-operations document, helps research administrators correctly scope what is and isn’t part of a manufacturing-site or CRO quality audit versus a clinical-site monitoring visit. Phase-appropriate GMP expectations also apply here: under 21 CFR 210.2(c), most Phase 1 investigational drug manufacturing is exempt from the full scope of 21 CFR Part 211 (per FDA’s 2008 CGMP-for-Phase-1 guidance), with full cGMP, including formal batch-record expectations, applying by the time a product reaches Phase 2/3 or commercial manufacturing.
Frequently asked questions
Is an EBR the same thing as an eBMR?
Yes — “eBMR” (electronic batch manufacturing record) and “EBR” are used interchangeably in industry practice; both refer to the same electronic batch-record concept.
Is EBR legally required by the FDA?
No. FDA does not mandate that batch records be kept electronically — a validated paper-based batch-record system that meets 21 CFR 211.188 is still acceptable. What Part 11 governs is what makes an electronic version of that record trustworthy and legally equivalent to paper if a manufacturer chooses the electronic route.
What software is used to run an EBR?
EBR functionality is most commonly delivered through a Manufacturing Execution System (MES) or a dedicated EBR/quality-management platform, validated for its intended use and configured to enforce the manufacturer’s approved Master Production Record for each product.
How does EBR relate to data integrity (ALCOA+)?
EBR systems are typically the primary mechanism manufacturers use to operationalize ALCOA+ data-integrity expectations (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available) for batch-level manufacturing data, since the system-enforced audit trail and access controls directly support several of those attributes in a way paper cannot.
Related terms
Machine-readable encodings
Use in your systems
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