Built by operators.For regulated industries.
Unifize is an AI platform for cross-functional work in regulated manufacturing.
What Unifize does
Four products on one platform. Start with one, add the rest when ready.
- QMS
Quality management
Non-conformance, CAPA, audits and supplier quality.
- DMS
Document management
Document control, change control and training.
- PLM
Product lifecycle
Specifications, design controls, FMEA and control plans.
- MES
Manufacturing execution
Work orders, travellers, first article inspection and batch records.
What makes Unifize different
Your eQMS keeps the record. Unifize holds the work that produces it.
| Your eQMS | Unifize | |
|---|---|---|
| What it holds | The approved record | The work that produces the record |
| Cross-team decisions | Made outside it, in email and meetings | Made on the record, with who, when and why |
| Audit evidence | The final document | Bound to each decision, with a Part 11 signature |
| Your systems | It stays your system of record | Runs alongside it, no rip-and-replace |
Who uses Unifize
Manufacturers in regulated industries.
The team behind Unifize
Founded in 2018 by two operators who ran regulated manufacturing.
Ben Merton
Co-founder and CEOBen spent fifteen years running a manufacturing business that supplied life sciences, with plants in the United States, China, South Korea and India, under ISO 13485 and ISO 9001.
Lakshman Thatai
Co-founderLakshman led operations in food processing, medical devices and consumer goods across the United States, China and India.
Palo Alto and Bengaluru
Pick an office to see the street.
How Unifize works
One process first, proven in ninety days. Then the next.
- 01
Pick one process
Start where the coordination tax is highest: change control, CAPA, supplier approval or audit prep.
- 02
Configure it together
Our team configures Unifize to your process with yours in the room, on top of the systems you keep.
- 03
Prove it in ninety days
Run the process live and measure cycle time and audit readiness against how it ran before.
- 04
Expand
Add the next process or product on the same platform when you are ready. Nothing is re-implemented.
Frequently asked questions
What is Unifize?
Unifize is an AI platform for regulated, cross-functional work. It runs change control, CAPA, supplier decisions and audit evidence on one accountable thread for manufacturers in regulated industries, with a 21 CFR Part 11 signature on every approval.
Does Unifize replace my eQMS?
No, unless you want it to. Unifize runs alongside the eQMS that already passed your audits and holds the work around it, so there is no rip-and-replace and no revalidation. Teams on spreadsheets and shared drives can run Unifize's QMS modules as their system of record.
How is Unifize different from MasterControl or Veeva?
MasterControl and Veeva store the approved record. Unifize holds the work that produces it: the investigation, the cross-team decision and the evidence, on one thread per event. You can keep your eQMS and run Unifize beside it.
Who founded Unifize?
Unifize was founded in 2018 by Ben Merton, the CEO, and Lakshman Thatai, two operators who ran regulated manufacturing across the United States, China, South Korea and India. The company works from Palo Alto and Bengaluru.
What does Unifize offer?
Unifize offers quality management (QMS), document management (DMS), product lifecycle (PLM) and manufacturing execution (MES) on one platform, plus a no-code process builder and Unifize AI for change impact and investigations.
How long does it take to get started with Unifize?
Unifize starts with one process, configured with our team in the room, and proves its value on that process in ninety days. You add the next process or product on the same platform when you are ready.
Practitioners. Not a consultancy.
Bring the process where the coordination tax is highest and we will run it with you, live, in a 30-minute walkthrough.