21 CFR Part 11
Immutable, validated audit log for every agent perception, recommendation, and control action, with e-signature-ready review flows.
Legal & trust
Plain language about data, terms, and claims.
The commitments behind the product: what we do with your data, what we promise contractually, and how we label statements that are not yet proven.
Privacy
What we collect and why
Marketing site: basic, privacy-respecting analytics and anything you voluntarily submit through a form. Product: process telemetry, PAT streams, and batch records processed under your instructions as a data processor.
- No sale of personal data, ever
- Form submissions used only to respond to your enquiry
- Product data processed under a written agreement
Your data
Routes, recipes, and spectra stay yours
Per-tenant isolation at the data and model layer. No cross-tenant training. Site-specific models derived from your corrections belong to you. Cross-site benchmarking is opt-in and de-identified.
- Data residency options for multinational networks
- Deletion and export on request
- On-prem and air-gapped deployment available
Terms
Terms of service, in summary
Subscription term, defined scope of autonomy, customer control over autonomy levels, mutual confidentiality, and clearly bounded liability. The full agreement is provided during procurement. [PLACEHOLDER — summary only]
- Customer retains ultimate control authority at all times
- Polymorra never bypasses plant safety interlocks
- Change control aligned to your quality system
Claim policy
How we label what is not yet true
We are pre-commercial. Any forward-looking capability, certification, or performance figure on this site is marked [ASPIRATIONAL]. Any figure awaiting real campaign data is marked [PLACEHOLDER]. Market sizes are internal estimates.
- [ASPIRATIONAL] — design target, not shipped or proven
- [PLACEHOLDER] — pending real customer data
- Internal estimates labelled as estimates
Subprocessors
Who touches what
Illustrative categories; the current list is provided contractually and updated with notice. [PLACEHOLDER]
| Category | Purpose | Process data? | Location |
|---|---|---|---|
| Cloud infrastructure | Training, fleet management, analytics | Yes (per agreement) | Customer-selected region |
| Accelerated computing | Model training and inference stack | Yes | Customer-selected region |
| Email & CRM | Responding to enquiries | No | EU / US |
| Error monitoring | Product reliability | Metadata only | EU / US |
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.
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.
Questions for your legal or quality team?
Start with one crystallizer or reactor train. Prove polymorph, yield, and reprocessing ROI in a validation-friendly pilot. Then expand across the plant.