What are electronic batch records? Rules, uses and cost

What are electronic batch records: a plain definition

An electronic batch record (EBR) is a batch record kept electronically instead of on paper, one record for each batch. BatchBuddy describes its own as step-by-step forms that stop an operator from skipping a step or leaving required data out. BatchBuddy's guide defines an EBR as a system-generated, electronically maintained record of one production run, and says a scanned or typed form saved as a PDF does not count.

A paper form can be handed in with a line blank; BatchBuddy says each step must be completed in sequence. For a dietary supplement, the batch production record itself is required every time a batch is made, on paper or electronically (21 CFR 111.255(a)).

An electronic batch record example, step by step

BatchBuddy's electronic batch records page draws a sample record, an illustration and not a customer record. Its steps include a weigh-in of an ingredient, a 45-minute blend at 800 RPM, QC sampling at 3 points and a QA e-signature release marked pending.

BatchBuddy says every weigh-in, blend time and QC reading is captured with a timestamp, lot number and the operator who did it. Its FAQ says a PDF batch record carries the lot number, formulation version used, every ingredient lot consumed and QC results.

What part 11 asks of them

For a dietary supplement, 21 CFR 111.605(c) says all electronic records must comply with part 11. Part 11 defines an electronic record as any combination of text, graphics, data, audio, pictorial or other information in digital form (21 CFR 11.3), so a spreadsheet counts as one.

21 CFR 11.10 asks the system for validation, accurate and complete copies of records, limited access to authorized individuals, secure time-stamped audit trails, record changes that do not obscure earlier entries, and operational checks that enforce the permitted sequence of steps. 21 CFR 11.50 asks that a signed record show the signer's printed name, the date and time and the meaning of the signature.

Part 11 does not apply to records required by part 117, the food rule (21 CFR 11.1). FDA does not certify software. BatchBuddy's trust center calls its Part 11 mapping self-assessed, and its own guide says third-party validation is in progress.

Paper, Excel or electronic records

21 CFR 111.605(b) lets a supplement maker keep original records, true copies or electronic records.

• Paper: InstantGMP's supplement page says paper batch records can work for very small operations but make traceability slower.
• Spreadsheet or PDF files: BatchBuddy's guide calls structured spreadsheets the simplest route; either file is an electronic record under part 11.
• Purpose-built software: BatchBuddy's guide describes integrated systems that connect batch records with formulations, inventory, quality and compliance.

What they cost a small maker

A 12-person food or supplement maker, asked by a retailer for batch records, can weigh a monthly plan against an annual license. BatchBuddy Manufacturer is $749 a month, billed monthly, or $7,490 a year, billed annually, for up to 15 members, as read on November 1, 2026. InstantGMP's Batch Records module is $20,000 a year and its EBR system $28,900 a year, each with the first 5 users. Wherefour, QT9 and BatchMaster publish no price.

BatchBuddy's electronic batch records page says operators can't skip steps or complete a record with missing data. Its plan cards put electronic batch records on Manufacturer; other vendor pages differ. Its terms say the software does not make a maker compliant on its own.

Best electronic batch record software compares the yearly bills; start with a batch record template if paper or Excel is enough for now. BatchBuddy offers a 14-day free trial with no credit card, while InstantGMP leads to a demo or a quote.