One of your lines makes a drug.

The warning letter is addressed to the whole company. BatchGlow is batch manufacturing software for contract manufacturers running cosmetics and OTC monograph products side by side, from the customer’s order to the released lot.

Become a pilot site See what it enforces

Watch: a dose can’t be recorded until the weight is right (56 s)

Pre-release, and taking three sites. You would work directly with the person writing the code. What does “G.L.O.W.” mean?

A vacuum mixer for cosmetics in a clean production room A homogenizer for creams and lotions in the same production room A tube filling machine
Equipment of a cosmetics plant. Pictures from Wikimedia Commons, credited at the foot of the page.

FDA is citing 211.

Everyone is selling MoCRA, and its cosmetic GMP rule under §606 has still not been issued, not even as a proposed rule. Meanwhile these five plants (three with “cosmetics” in the name on the door) were cited under drug cGMP, because FDA classes what comes off their lines as drug products: the regime follows the product, not the company's self-description.

Columbia Cosmetics Manufacturing 11 Sep 2025 §211.192 discrepancies uninvestigated; no process validation CDL Services dba Technichem 24 Nov 2025 Ethanol untested for methanol; §211.22 quality unit Purolea Cosmetics Lab 2 Apr 2026 §211.165(b) microbial testing; AI-drafted records approved unreviewed (§211.22(c)) Active Cosmetics Manufacturing 22 Apr 2026 §211.192 discrepancies; test methods unvalidated Woodbine Products Company 27 Jul 2026 §211.100 written procedures; no process validation

Each of these findings comes down to a record: whether it exists, with a name and a timestamp on it, and whether it holds up. Do not take my word for it: read the Technichem letter. FDA notes in it that some of the firm's products may be regulated as cosmetics, and cites the firm under drug cGMP anyway.

Two regimes, one system

When your sunscreen line and your face-cream line share a floor, one of them is a drug, made under drug cGMP, 21 CFR 211. BatchGlow is built for exactly that split: drug cGMP where the product is a drug, and on the cosmetic line what cosmetic law requires, with everything else set the way the plant runs it.

What is on the line?

OTC monograph product · drug cGMP

Full 211 gating

The active’s weight set from each lot’s assay before it is weighed, a second person checking each weighing and addition, the plant’s own identity test on every lot, release on a passing assay. Adding active to a batch already made is reprocessing, and goes through QA’s signed path.

Cosmetic product · cosmetic law

The law, then your settings

Cosmetic law stops the work, and so do a few BatchGlow rules: quarantine at receipt, lot traceability, two owners’ material never mixed. Clean hold, line clearance and release discipline are plant settings marked “not required by law”, most on by default, any of them yours to switch off. Stamping “211” across cosmetic processes as if it were law is both legally wrong and operationally expensive.

The whole system is organized around this split: a formula becomes OTC by itself the moment one of its ingredients is an OTC drug component.

BatchG.L.O.W.

Guided Lifecycle & Operations Workflow

A batch has one continuous life, from the drum that arrives at your dock to the retain sample still on a shelf long after the last unit of that lot has expired, and the gaps between systems are exactly where the records go missing.

How a batch runs, stage by stage
The pre-weigh terminal beside the scale it reads: 0.500 kg net, in tolerance
The pre-weigh terminal. Demo setup and demo data; parts of the video are sped up. Not every scale accepts commands, and each family tares differently, so BatchGlow reads the weight the scale displays and subtracts the empty container itself. The scale keeps showing the full weight.

The whole plant

One system from the customer’s order to the released lot: the formula, the schedule, the purchase order, the dock, the lab, the warehouse, the kettle, the line, the equipment and its cleaning, the devices on the floor and the quality system, each part built to the rule that governs it, and every bill, invoice and payment sent to QuickBooks for your accountant.

Formulas & approvalVersioned formulas and ISA-88 mixing procedures, signed by R&D and QA, changed only through change control. Purchasing & suppliersOne purchase order across several orders, with price tiers and minimums; suppliers qualified per material and manufacturer. Receiving & QC labEvery lot into quarantine, every drum labeled; sampling plans, two-signature results, OOS investigations, retains and stability. Warehouse & inventoryBin locations by zone, drum balances to 0.0001 kg, material reserved only once it is released. Orders & planningThe customer’s order and deposit, batch mass from the order lines, material checks, a scheduling board. Pre-weigh & compoundingEvery dose weighed against the signed BOM, phases in their order, a second person where the rule asks for one. Filling & packagingNet contents to NIST Handbook 133, print checks, labeling reconciliation, GS1 pallets and kits. Equipment & cleaningClean-hold clocks, signed cleaning records, a changeover matrix, maintenance schedules and calibration at use. Devices on the floorScales and sensors read through BatchGlow Connector, no commands sent; labels print only at a person’s press; scanners by tablet camera or USB. QualityDeviations that open themselves, change control, complaints, adverse events and recalls. Release & shippingQA-signed lot release, the owner’s release for contract OTC, shipping gated on every document. Accounting & QuickBooksEvery bill, invoice, payment and deposit is kept in BatchGlow and copied to QuickBooks Online, where your accountant keeps working and QuickBooks handles the sales tax.

What it enforces

Six rules the system holds, and why.

90 sSignatures you can defend in an auditA single-use signing token that expires in 90 seconds, bound to the meaning of that one signature. Every lotNothing gets used before it has been testedThe plant’s own identity test on every lot of an OTC component; the lot stays in quarantine until QC signs its decision, and only a signed emergency decision takes it out sooner. Both waysEvery drum traced forward and backwardA batch has a parent for every raw-material lot in it, and a rework blend or a kit adds more; a recall walks them all. 701.3Formulas, INCI decks and the cosmetic paperworkINCI decks built from raw-material breakdowns and ordered per 21 CFR 701.3. TitleCustomer-owned material stays its owner'sTwo clients' material cannot be combined into one lot. SHA-256A tamper-evident trail, and what it coversSignatures, change control and the key acts on the floor, sealed every five minutes and anchored outside the database. It does not cover every row.

What a pilot involves

BatchGlow is pre-release, and I am looking for three US contract manufacturers to build it against real production, not a demo dataset. Preference goes to plants running both cosmetics and OTC monograph products.

What it does not have, and the established systems do: years of production history, a certification, an audit trail of other people's inspections. If that is what your situation needs, choose one of them: how the options compare.

What you get

  • Your own instance, hosted and run by me, configured to your procedures. Nothing to install at the plant but the BatchGlow Connector, on the shop-floor PC your scales and instruments plug into. Your people open a browser.
  • Your formulas, raw materials, suppliers and specifications loaded for you from your spreadsheets and exports. Your QA reviews them, and each formula and supplier is signed before it goes live. You won't need outside programmers.
  • A direct line to the person writing the code, and a say in what gets built next.
  • No charge during the pilot. At its end we agree your price per production site, and that price stays fixed for three years from the day you subscribe.

What I need from you

  • About two hours of QA time a week. That is the cost of the pilot: a pilot nobody uses teaches neither of us anything.
  • Real batches in the system, running alongside your current process until you trust it.
  • Your honest reading of your own line clearance and receiving procedures, so I build to what your floor actually does.
  • Permission to describe what we did together, once you are happy with it.

How the pilot runs: a look at three sample sheets of your data and your procedures; your data loaded as drafts for your QA to review, with each formula and supplier signed; real batches run alongside your current process; then you decide to subscribe, extend or stop.

Terms are set in a written pilot agreement, signed before any real GMP record goes into the system.

Pricing after the pilot

Per production site, with unlimited users and unlimited shop-floor terminals. Charging per seat is what pushes plants onto shared logins in the first place, and a shared login makes every electronic signature in the building worthless. Tiers scale with the number of packaging lines, never with headcount. Part 11 signatures and lot traceability sit in the base tier and will never move behind an upgrade. The numbers are set with the first three sites at the end of their pilots, and the price you agree stays fixed for three years.

Become a pilot site Ask about your process

Eleven years as one plant's ERP developer

Sergey Belii, founder of BatchGlow
Sergey BeliiFounder, and the person writing the code

Where it comes from

I am a contract developer. For eleven years I worked, remotely, as the developer of the production ERP at Tropical Labs in Tampa, a contract manufacturer making cosmetics, OTC products and supplements in one building. That is the exact plant this product is for. I wrote the software that plant ran on, to requirements from the QA and production people who had to live with whatever I shipped. BatchGlow is not that system. Theirs stays theirs. This one is written from scratch and shares no code with it.

The history on LinkedIn

Questions to ask

What happens to my records if you stop working on this?
Fair question: you are one person. The answer is in the structure: your data sits in a standard relational database. One command takes the whole site out whenever you ask (batch records, signatures, audit history, genealogy, master data and attachments) in CSV and JSON, with the audit chain in a form anyone can check again; a dump of the database itself is there too. You are not buying into a shape only I can open, and handing the instance over to you or to another provider is a documented procedure the agreement refers to. For a system holding records you are required to keep for years, that should be a condition of purchase from any vendor, me included.
Is BatchGlow a validated system?
No software vendor is. FDA does not approve, certify or license ERP and MES products, and anyone claiming to be “FDA approved” software is telling you something that cannot be true. Validation is performed by you, on your own instance. What a vendor can do is make that cheap: supply the requirements, the traceability from each regulatory requirement to the test that exercises it, and documented change control. Every regulatory requirement is tagged in the source for exactly this, and each release comes with its traceability matrix, from each requirement to the tests that exercise it, together with the release notes, an impact assessment and the test evidence.
We only make cosmetics, no OTC. Is this for us?
For a cosmetics-only plant the case is weaker. 21 CFR Part 11 attaches only to records a predicate rule requires you to keep, and since FDA has not issued the MoCRA cosmetic GMP rule, a cosmetics-only manufacturer has no US electronic batch record mandate today. The traceability, receiving and release discipline still pay for themselves, and a brand owner can require that data in the quality agreement. But if someone is selling you Part 11 as a legal obligation for a pure cosmetic line, they are overstating it.
Do we pay per user or per device?
Never. Pricing is per production site, tiered by packaging lines, with unlimited user accounts and terminals.

Talk to me about a pilot

Tell me about your plant. I read every message myself and reply within two business days, including when the answer is that BatchGlow is not the right fit for you yet.

Your formulations, customers and production details stay confidential and are never shared. I am happy to sign your NDA before we talk specifics.