AMNI Operate · formerly ezGMP
Run your plant on the network
AMNI Operate integrates everything from inventory and planning to production and quality control in one validated system — and every COA and batch record it generates flows to the Amni Network automatically, so your partners get the documents without anyone touching them.
Modules
One system, every part of your operation
AMNI Operate brings inventory, production, quality, and documentation together so your team works from a single source of truth.
Compliance
Validated for regulated manufacturing
AMNI Operate is validated to 21 CFR Part 11 (e-signatures and e-records) with predicate-rule coverage for Part 111 and Part 117, and is designed to support Part 211 and Part 820 operations.
21 CFR Part 111
Nutraceuticals
Validated predicate rules
21 CFR Part 117
Food & Beverage
Validated predicate rules
21 CFR Part 211
Pharmaceuticals
Designed for
21 CFR Part 820
Medical Devices
Designed for
Amni Network
Documents made on the line, delivered to the network
AMNI Operate is Door 3 of the Amni Network. Every COA, batch record, and qualification document your plant produces reaches the customers and partners who need it automatically — building your verified network profile as a by-product of daily work.
“We were looking for a digital batch record and inventory system that would enhance our productivity and fortify our Quality Management system. AMNI provided ezGMP, a customizable software system that met all of our manufacturing and regulatory needs.”
“The team at AMNI is knowledgeable and very helpful in making sure the system meets our needs. I can't wait to see this expand across multiple industries to bring more open accountability to companies.”
FAQ
AMNI Operate questions, answered
ezGMP is now AMNI Operate — same validated product, same team, new name that reflects its place as the production door of the Amni Network. Nothing changes for existing customers.
Yes. AMNI Operate can integrate with a variety of software applications. Contact us with your specific requirements.
Yes. AMNI Operate is built to run your manufacturing line end to end. We work with leading equipment suppliers to automate data entry and reduce user errors — reach out to learn about our equipment integration process.
AMNI Operate is completely cloud-based.
AMNI Operate is the production door into the network. COAs, batch records, and qualification documents generated on your line flow to the trading partners who need them automatically — no re-entry, no emailing PDFs. The network works standalone too, but AMNI Operate automates the whole flow.
Yes. AMNI Operate is validated to 21 CFR Part 11 standards (e-signatures and e-documents) and all predicate rules for 21 CFR Part 111 and Part 117.
See AMNI Operate run your manufacturing line
Production, quality, and documentation in one validated system — connected to your whole supply chain.