Not sure of
your category?
Tell us what you make. We’ll find the right blueprint, or mix of packs, for your plant.
Call us• Industries
Seven industries.
One platform.
One core runs materials, batches, quality and dispatch for every regulated plant. Each industry pack adds the workflows, checks and compliance controls your industry needs. We add more industries on request.
Batch recordsAssay resultsQA release
Pharmaceuticals
From formulation to batch release.
Vials, blister packs and assay evidence stay connected to the manufacturing record.
Regulatory packs
Pick your industry.
The core stays the same.
Each pack carries the frameworks, records and controls for its industry, on top of the same core.
Pharmaceuticals
The batch record writes itself as the batch runs
FDA 21 CFR Part 11EU Annex 11 / EU GMPRevised Schedule M
Medical Devices
The device file assembles itself as the work happens
FDA 21 CFR Part 820 / QMSRISO 13485:2016ISO 14971:2019
Food & Beverage
The HACCP plan as something that executes
FSSAI Schedule 4 Part IICodex CXC 1-1969 HACCPFSSC 22000 / ISO 22000:2018
Nutraceuticals
Identity testing enforced as a gate, not a certificate
21 CFR Part 11121 CFR Part 117 Subpart BFSSAI health supplements
Cosmetics
The Product Information File held continuously
ISO 22716:2007MoCRARegulation (EC) 1223/2009
Veterinary
One unbroken trace from premix to treated animal
Regulation (EU) 2025/2091Regulation (EU) 2025/2154 / VICH GL60Regulation (EU) 2019/6
API & CDMO
An audit pack that is a filtered view, not a project
ICH Q7EudraLex Volume 4 Part II / Chapter 7Revised Schedule M
Not sure of
How it works
One manufacturing core.
Made for your industry.
All four, working as one
Your manufacturing setup.
Industry workflows. Selected controls.
Verified setup checkpoints.
01 / 04 · Core systems
Make it your workflow
Tell us what you make.
We will map the pack.
Describe your products and markets. We will walk you through the controls that apply, on your own batch.