21 CFR Part 11
Immutable, validated audit log for every agent perception, recommendation, and control action, with e-signature-ready review flows.
Security & compliance
If QA cannot approve it, it does not ship.
Polymorra was designed backwards from the validation review: immutable audit trails, grounded and citable outputs, bounded autonomy, and model versions that are locked, documented, and reversible.
100%actions audited
0cross-tenant training
3autonomy levels
Trust & compliance
Validated for GMP manufacturing
Polymorra is engineered for regulated drug-substance production: grounded outputs, immutable audit trails, graduated autonomy, and validation documentation from day one.
GMP / ICH Q7
Change control, validated model versioning, and deployment documentation designed for drug-substance manufacturing.
SOC 2
SOC 2 Type I in progress, Type II on the roadmap; SSO/RBAC, encryption in transit and at rest. [ASPIRATIONAL]
Route & IP protection
Per-tenant isolation of routes, recipes, spectra, and crystal images. No cross-tenant training. On-prem option.
Graduated autonomy
Shadow → assist → bounded auto-control. Every autonomy level is explicitly configured, bounded, and revocable.
Grounded outputs
Every recommendation cites the spectra, images, telemetry, SOP, or specification it was derived from.
Plant-edge first
Inference runs on-site so control loops survive network loss; cloud is for training, fleet, and analytics.
Human-in-the-loop
Chemist and QA checkpoints are first-class: approve, correct, or reject — and every correction trains the models.
21 CFR Part 11
An audit trail that survives an inspection
Every agent perception, recommendation, human approval, correction, and control action is written to an append-only record with time, identity, inputs, and rationale.
- Append-only, tamper-evident storage
- Identity and e-signature-ready review flows
- Complete replay of any batch decision
- Exportable evidence packages
Validated AI
Model versions are change-controlled artifacts
A model in a GMP plant is not a continuously updating service. Polymorra locks the version running on a qualified train, documents its training data and performance, and makes rollback a single, logged operation.
- Version locks per train and per route
- Documented training provenance and validation results
- Change control aligned to your quality system
- Shadow evaluation of a new version before promotion
Autonomy
Graduated, bounded, revocable
Autonomy is never a switch that someone flips. Each train is explicitly configured at shadow, assist, or bounded auto-control, with hard limits the agent cannot exceed and instant handback to the chemist.
- Hard safety envelopes independent of the model
- Instant manual override at any autonomy level
- Every autonomy change is itself an audited event
Data protection
Your route is your most valuable asset
Routes, recipes, spectra, crystal images, and batch history are isolated per tenant at the data and model layer. No cross-tenant training. Cross-site benchmarks are opt-in and de-identified.
- Encryption in transit and at rest
- SSO, RBAC, and least-privilege service accounts
- On-prem and air-gapped deployment options
Certification
Where we are, honestly
We mark aspirational items rather than implying certifications we do not yet hold.
- Now
Part 11-ready architecture
Immutable audit trail, e-signature-ready flows, validated version locks in the product today.
- In progress
SOC 2 Type I
Controls implemented and under audit. [ASPIRATIONAL]
- Next
SOC 2 Type II
Observation window follows Type I. [ASPIRATIONAL]
- With customers
IQ/OQ/PQ support
Validation package and qualification support delivered alongside each deployment.
Plant-edge console
One screen for the batch that is running right now
Supersaturation, particle size distribution, predicted polymorph, impurity trajectory, and the next control move — with the evidence behind each number.
Polymorra plant-edge console showing live supersaturation, particle size distribution, predicted polymorphic form, and impurity trajectory for a running crystallization, with the recommended next control move.
Integrations
Connects to the systems already running your plant
Polymorra reads and writes through the reactor DCS, PAT instruments, crystallizer and isolation skids, historians, and MES you already validated.
Reactor control & DCS
Emerson DeltaVSiemens PCS 7Honeywell ExperionOPC UAModbus/TCP
PAT & analytics
Mettler-Toledo FBRMPVM in-situ imagingReactIREndress+Hauser RamanNIRHPLC / XRPD imports
Isolation & drying
Nutsche filter-dryersCentrifugesAgitated dryersConical millsMicronizers
MES, historian & quality
Körber PAS-XEmerson SyncadeOSIsoft PILIMSeBR / QMS exports
Enterprise
Built for multi-site pharma and CDMO networks
Multi-site deployment, plant-edge fleet management, custom route and crystallization models, validation support, and on-prem or hybrid installation with NVIDIA AI Enterprise.
Fleet of plant edges
Manage models, autonomy levels, and versions across every train in every site from one control plane.
Validation package
Qualification documentation, model version locks, and change-control artifacts your quality unit can review.
Outcome-linked pricing
Enterprise agreements can tie a component of fees to polymorph consistency, yield, or reprocessing reduction.
Dedicated engineering
Solutions engineers who speak crystallization, PAT, and GMP — not just software.
FAQ
Frequently asked questions
Both — in a deliberate order. Polymorra starts in shadow mode (perceive only), moves to assist (recommend, chemist approves), then to bounded auto-control on qualified trains where setpoint moves stay inside validated control windows. Every level is configured per train and revocable.
Polymorra is built for GMP (ICH Q7) and 21 CFR Part 11: immutable audit trail, validated model version locks with rollback, change control, grounded and citable outputs, and human-in-the-loop checkpoints. We ship a validation package and support IQ/OQ/PQ activities with your quality unit.
API or OPC access to your reactor DCS, PAT instruments (Raman, FBRM, PVM, NIR), crystallizer and isolation skids, and MES or historian — plus a train with enough campaign volume for clear ROI.
No. Per-tenant isolation of routes, recipes, spectra, and crystal images is enforced at the data and model layer. Cross-site benchmarks are opt-in and de-identified.
A typical wedge pilot instruments one train, runs shadow mode over a baseline campaign, then moves to assist mode with a defined polymorph, yield, or reprocessing success metric agreed up front.
Perception and control inference run at the plant edge. Cloud handles training, fleet management, and analytics — losing it degrades reporting, not the batch.
Bring your quality unit to the first call.
Start with one crystallizer or reactor train. Prove polymorph, yield, and reprocessing ROI in a validation-friendly pilot. Then expand across the plant.