One system for the plant.
The audit built into it.
Fifteen modules, from indent to balance sheet — with the electronic batch record, the LIMS and the QMS a generic ERP does not have.
Granulation time is running 12% above this product's normal range. Two prior batches with this pattern lost yield at drying.
Most plants run three systems that do not agree
The batch record is paper
Completed after the fact, signed by the wrong person, quietly corrected. Nobody can prove otherwise.
The lab is an island
Specifications here, results there, the COA typed by hand. A retest date passes unnoticed.
Costing arrives late
By the time the batch cost is known, four more have run at the same yield.
Fifteen modules that already know each other
A dispensing step moves stock. The movement books the cost. A failed check raises a deviation, and the deviation blocks the release.
Supply chain
Manufacturing
Quality & regulatory
Business & control
AI that notices, not AI that chats
Yield variance explained. OOS triaged. Deviations clustered by cause. It never signs anything — a qualified person still decides.
How the AI works MIThe number comes off the equipment
Balances, HPLC, process equipment, cleanroom sensors and stability chambers — read directly, so nothing is transcribed.
What we connectDesigned around the audit trail
Cannot be deleted
Append-only store, delete permission stripped at database level. Not even an administrator.
Reason for change
What changed, who, when — and why. Without the why it is a log, not an audit trail.
Signatures mean something
Performed by, verified by, approved by. Each re-authenticated, each bound to a record version.
Validation delivered
IQ, OQ, PQ and the traceability matrix handed over with the build.
Built for every kind of pharma manufacturer
See it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.