Live signal fusion
Bioburden, environmental, and process data combined into one contamination and deviation picture.
Quality & assurance · contamination and review
Catch contamination early. Review by exception.
Live contamination and deviation intelligence, plus a batch record that clears itself where it is in spec and surfaces only what a person needs to sign.
Runs on Jetson Orin/Thor at the edge, DGX/HGX for training
The problem
Two failure modes haunt every suite.
A single bioburden or environmental event can destroy a batch worth millions and shut a suite for weeks, and it is usually caught too late, from lagging assays. The signals that would warn you sit scattered across bioburden, environmental, and process data that no one fuses live.
Then there is release. Deviations pile up across a batch, and a human reads every parameter of every record to release the drug under 21 CFR Part 11. That manual review is a bottleneck that delays release and ties up scarce quality staff.
What Sentira does
One early-warning system, and a review that clears itself.
Sentira fuses bioburden, environmental monitoring, and process telemetry into a live contamination and deviation picture, raising warnings before an event crashes the batch. It then reviews the batch record by exception, clearing in-spec parameters automatically and surfacing only the true deviations for a human, with every decision sourced and signed to a Part 11 audit trail. Days of manual review become hours.
Early warning
Alarms with a confidence and traceable evidence, before the assay confirms the event.
Review by exception
In-spec parameters cleared automatically, so reviewers see only the deviations that matter.
Immutable trail
Every decision recorded to a Part 11-validated, immutable audit trail.
Fits your stack
Connectors to environmental monitoring, bioburden assays, DCS, and MES.
Learns across suites
Every deviation across the network sharpens the next early warning.
- Multivariate contamination and deviation anomaly detection
- Synthetic augmentation of rare contamination and batch-failure patterns
- SOP and record-grounded reasoning for review by exception, with citations
- Deviation root-cause suggestion tuned on partner history
Under the hood
Fusing the signals no one watches together.
Environmental monitoring and MES review sit in separate silos, both largely manual. Sentira fuses the signals live and reviews by exception, cutting release time and catching contamination early. Its cross-site library of contamination events and deviation patterns is what point tools cannot assemble.
Built on NVIDIA
GPU-essential for live fusion and record reasoning.
- Edge hardwareJetson Orin and Thor (IGX) run edge fusion and anomaly inference near the suite for fast early warning.
- TrainingDGX and HGX train anomaly and record-reasoning models over deviation and batch-record corpora.
- LibrariesCUDA and TensorRT accelerate real-time anomaly inference. Cosmos and Omniverse Replicator synthesize rare contamination and failure scenarios. Morpheus accelerates the high-volume telemetry pipelines.
- ServingTriton and NIM serve anomaly and review models. NeMo fine-tunes the SOP-grounded record reasoning, all under NVIDIA AI Enterprise.
Commercials
Board-visible savings on review hours and lost batches.
- PricingBundled into the Bioseon Site tier at $85,000 per month as the contamination and review layer, with a premium enterprise tier for custom deviation models and validated review packages.
- Who buysQA and quality directors and MSAT hold the budget, QA and PAT managers champion it, regulatory and validation approve.
- The moatA proprietary cross-site library of contamination events, deviation patterns, and batch-record outcomes, collected across the whole network rather than one plant.
- First deploymentFuse environmental, bioburden, and process feeds for one suite, ship contamination early-warning alarms, then run review by exception over one product's records with Part 11 sourcing.
Where it fits
Sentira watches over every module.
Cut review time where the pain is sharpest.
Review-hour reduction and contamination early warning are savings the board can see. Point Sentira at one suite and one product's records to start.