A distributed network is only as strong as the intelligence that runs it. Cerebex OS is the digital layer that unifies facility data, automates routine compliance work, and puts specialized AI agents to work across your manufacturing operation, always under human review.
The AI operating system for biomanufacturing.
CEREBEX OS™
Status: In active development. A live demo is in progress.
Categories in the QMS library, aligned to FDA and ICH
11
Pre-written SOPs, delivered as the subset that applies to you
~180
Editions, US cGMP, EU, and global, built modularly
3
Compliance work is where speed goes to die.
THE PROBLEM
A modern manufacturing operation runs on systems that do not talk to each other and paperwork that consumes the people who should be making medicine. Small teams carry the same documentation burden as large ones. The result is slower batches, more deviations, and quality staff spending their days transcribing instead of thinking.
THE DIGITAL WORKFORCE
Specialized agents for the work nobody has time for.
Digital twins
Model a process and a facility before and during a run, so problems surface on screen instead of on the floor.
Deviation and batch-record drafting
Draft deviations and batch records against the rules for a qualified person to review and approve, not from a blank page.
Supply chain management
Track materials, status, and constraints across the network in one view.
Image and camera tracking
Monitor technique, operations, and flag anomalies for a person to review and act on.
QMS IN A BOX
A library of roughly 180 pre-written SOPs developed with reference to FDA guidance and ICH guidelines, delivered as the subset that applies to your operation, never a dump of the whole library. Built in a US cGMP edition, a separate EU edition, and a global edition that supports the workflows for QP release, MIA licensing, and the Annex 1 aseptic set as well as others. Start with non-critical activities and expand in step with your validation plan and your regulatory engagement.
A compliant quality system, ready to run.
DEPLOYMENT
Run it the way your data requires.
SaaS
Hosted and maintained by us.
On-premises
Runs local, inside your environment.
Hybrid
Split the way your data and your validation require.
WHY IT COMPOUNDS
Every deployed FAST GMP pod stays connected to Cerebex OS. Your manufacturing telemetry trains models scoped to your operation, so reliability and insight improve with every batch. Data and models stay isolated to each client.
Every batch makes it smarter.
See what a digital workforce does for your operation.
Tell us about your program. We will show you the platform.