Supplement batch record software: do you need it, and which option fits a small maker?

Supplement batch record software: do you need it yet?

Not necessarily. Under 21 CFR part 111 a supplement maker must prepare a batch production record every time it makes a batch, and that record must accurately follow the master manufacturing record. Section 111.605 says records may be kept as original records, as true copies or as electronic records. The rule names no software; it asks for the records.

If you keep records electronically, the same section says they must comply with part 11 of the chapter. Part 11 sets out controls such as limited system access and secure, time-stamped audit trails. Its scope clause covers records in electronic form kept under FDA records requirements, so spreadsheets used as the record are worth raising with a qualified regulatory consultant.

Your options: paper, spreadsheets and six software routes

• Paper batch sheets: allowed as original records. Filing, retrieval and keeping them for 1 year past shelf life, or 2 years past the last distribution, are your job.
• Spreadsheets: electronic records, so the part 11 point above applies.
• Katana: its pages describe lot and serial tracking and expiry dates, a free plan limited to 30 SKUs and a custom annual contract. Ask whether a master manufacturing record and signed production steps can live in it.
• BatchBuddy: four self-serve plans on a monthly ladder, a 14-day free trial, and plan cards that place electronic batch records on the Manufacturer plan and up. See the BatchBuddy review.
• InstantGMP: annual licenses by module, a Batch Records module for electronic master and batch records, the first five users included and services quoted separately. See BatchBuddy vs InstantGMP.
• Wherefour: a custom quote with monthly, quarterly or annual billing. Its pages describe production and batch control, certificate of analysis storage, audit trails and FSMA 204 traceability, with guided onboarding.
• BatchMaster and QT9: BatchMaster describes cloud and on-premise ERP for growing mid-market formula-based manufacturers, with a nutraceuticals page and no plan amounts. QT9 prices by quote from users, product and deployment, and describes its software as pre-validated and Part 11 compliant, which is its own wording.

Criteria to compare: what the records must show

• Master record: one for each unique formulation and each batch size, with components, weights, theoretical yield, packaging and written steps (21 CFR 111.205 and 111.210).
• Batch record: made for every batch, following the master, with lot numbers, actual yield, test results and the date and initials for each step (111.255 and 111.260).
• Second-person checks: for manual operations, one person weighs or measures and another verifies, and one adds and another verifies the addition (111.210).
• Quality review: documentation that quality control personnel reviewed the record and approved or rejected the batch for release (111.260).
• Electronic records: access limits, secure time-stamped audit trails and validation, as listed in 21 CFR 11.10.
• Retention and retrieval: required records must be kept for the period above and be available to FDA on request, according to FDA's small entity guide.

Trade-offs and fit by maker type

• Small supplement brand making its own batches: a monthly self-serve plan can be tried at low commitment, but check which plan holds batch records and whether the signatures you need come with it.
• Co-packer with many client formulas: InstantGMP and BatchBuddy both describe keeping each client's materials and records apart; ask how that works on the plan you would buy.
• Cosmetics maker: FDA's MoCRA page says the law requires FDA to establish GMP regulations for cosmetic facilities, links a draft guidance on cosmetic good manufacturing practices and says certain small businesses are exempt from GMP, registration and listing, with exceptions for some product types. Vendors market MoCRA and ISO 22716 support, so check the FDA page for your product.
• Food producer: FDA's part 117 rules cover human food, and 21 CFR 11.1 says part 11 does not apply to records required by part 117. Part 111 is not on that list, so supplement records are treated differently.

Five checks to run in any demo

InstantGMP's own supplement page suggests four of these tests for any vendor demo, and the second-person check comes from 21 CFR 111.210. They apply to every option above.

• Receiving and quarantine: receive a raw material and try to use it before QA releases it.
• Batch record from master: create a batch record from an approved master and try to change a step without change control.
• Second-person verification: confirm a different user must verify each weigh-in and addition.
• Trace one lot: pick a finished lot and trace every component lot, test result and signature in one report.
• Audit trail: edit a record and check that the trail shows who, what, when and why.