For 21 CFR 111 supplement manufacturers
Inventory, manufacturing, and 21 CFR Part 11 in one system.
Nexeion runs your warehouse, your production floor and your GMP quality system on one database — so the batch record and the stock ledger can never disagree.
No credit card, no checkout, no implementation fee. Enrollment is by email.
The problem
Right now you are paying for the gap between two systems.
Every inventory and MRP tool in the small-business price band — Cin7, Fishbowl, Katana, MRPeasy, Unleashed, Finale, Zoho — ships zero 21 CFR Part 11 capability. Every real electronic quality system — Qualio, MasterControl, Greenlight Guru, QT9 — ships zero batch traceability.
So you buy both, pay to integrate them, then validate the interface between them — and still reconcile by hand when the batch record and the stock ledger drift apart. Nexeion closes both halves in one subscription, because they were never two problems.
4 of 7
Alternatives we compared with no Part 11 at all
135
Shipped capabilities, listed in full
$0
Implementation fee
The platform
Eleven modules. One ledger underneath all of them.
Inventory & Catalog
One reconciled stock picture across locations, quality states and sales channels — not a warehouse number and a spreadsheet that disagree.
14 capabilities →05Manufacturing & Planning
Recipes that scale to batch size, production that posts in one atomic transaction, and a forecast that nets POs against production draw-down.
15 capabilities →07Quality Management & 21 CFR Part 11
The wedge. Electronic signatures, an append-only audit trail and release gating enforced in the same database that holds your stock.
24 capabilities →06Traceability & Recall
Trace either direction in seconds, then run the mock recall your auditor asks for — with a drill clock and signed closure.
11 capabilities →10Integrations & API
Read your channels, publish your events, and let your own systems — or your AI agents — drive the workspace under scoped keys.
10 capabilities →09Analytics & Reporting
The numbers a buyer, a planner and an auditor each need — computed from the ledger, not re-keyed into a spreadsheet.
10 capabilities →Why an auditor believes it
Compliance you can demonstrate, not compliance you assert.
Anyone can put a signature box on a form. These are the four controls an FDA investigator actually tests — and where they are enforced.
- 01
Signatures the server owns
24 GMP actions sit behind a live re-authentication gate — password plus authenticator inside a five-minute window. The signing IP is derived server-side and the meaning of the signature is fixed by the server, so the client can never choose its own wording.
- 02
Release blocked by the database
Identity test, heavy metals, finished COA, supervisor sign-off, retain sample, no active hold. The release stays refused until the server independently confirms every one — not until someone ticks a checklist.
- 03
An audit trail with no delete path
Append-only, with full before/after row capture across items, batches, lots, POs, manufacturing orders, deviations, CAPAs, SOPs, training and HR records. There is no update or delete route for any application user, including the workspace owner.
- 04
Segregation of duties in Postgres
A manufacturing role can complete production but cannot sign a QA disposition, and change-control approval rejects the same person signing as both QA and Manufacturing. Enforced in the database, not hidden in the interface.
Roughly 50 database-level regression tests prove these controls still hold, and run in CI on every change — documented evidence for your own validation package.
Read the compliance module →Pricing
Priced against the tools that cannot do this.
Operations
$329/mo
billed annually · $399/mo month-to-month
Inventory, warehouse and order operations on one ledger.
5 users · 2 warehouses · 2,500 sales orders/month · unlimited SKUs
Manufacturing
$699/mo
billed annually · $849/mo month-to-month
Add the production floor: BOMs, work orders, MRP and lot genealogy.
15 users · 5 warehouses · 10,000 sales orders/month · unlimited manufacturing orders
Compliance
$1,295/mo
billed annually · $1,595/mo month-to-month
The Part 11 quality system, inside the same database as your stock.
40 users · unlimited warehouses · unlimited orders · unlimited manufacturing orders
List prices for orientation. There is no checkout on this site — nothing is charged from these pages. Enterprise is quoted individually.
Tell us what you make and how you are audited.
We will set up your workspace, import your catalog and show you the release gate running against your own products.