Assurance‑driven AI/ML, from embedded to cloud.
Noviscent builds AI and ML systems for regulated teams. We deliver embedded, OT, and cloud AI workflows with compliance, traceability, and audit-ready documentation built in.
Suites
The Noviscent Assurance‑Driven AI Suite
Start with a tiny wedge. Stack modules over time. Everything exports regulator‑ and auditor‑ready artifacts.
RegOps Foundry
Generate PCCPs, AI‑SBOMs, and bilingual eval scorecards. Evidence, not slides.
TraceChain for Quality
One‑click Audit Packs from Jira/Helix/Confluence/Git with e‑signatures, timestamps, and lineage.
Post‑Market Intelligence Cloud
Ingest adverse events & service logs, deduplicate signals, draft CAPA stubs, export to regulators.
EdgeWorks AI
Run LLM/vision flows fully on‑prem or VPC. Policy sandbox, kill‑switch, and IT‑approved telemetry.
Synthetic Reality Lab
Rare‑failure generators and EN/FR stress‑tests to prove robustness without exposing PHI.
Canadian‑grade Compliance
Data residency (CA), PHIPA/PIPEDA alignment, bilingual outputs. Auditor‑friendly by design.
From zero to audit‑ready
Fixed‑scope. Auditor‑friendly.
We replace governance theatre with real artifacts your auditors will sign off.Wire 2 systems
Connect tools for Project Management/Application Lifecycle Management/Code Management/Knowledgebases or EMR/CMMS in a scoped sandbox.
Generate artifacts
PCCP + AI‑SBOM + Audit Pack with cross‑links, signatures, and lineage.
Decide with proof
Keep the pack, expand to subscriptions, or pause — no long commitments.
Private by default
EdgeWorks: on‑prem & VPC AI that IT approves
Offline Agent Runner
Policy‑sandboxed LLM/vision flows. No internet required, kill‑switch included.
Connector packs
PLC/SCADA, PACS/EMR, cameras, CMMS. Start with your highest‑value flow.
Audit telemetry
Immutable logs: prompts, model hashes, decisions, and redactions.
Bilingual redaction
EN/FR PHI scrubbing and re‑ID risk reports for privacy reviews.
Push‑button proof
TraceChain: compile your audit pack in minutes
Cross‑tool traceability
Requirements → risks (FMEA/CAPA) → tests → release, all cross‑linked.
GSN composer
Auto‑draft assurance cases with goal structuring notation.
Risk‑drift alerts
Commits and test failures nudge updates to FMEA/CAPA docs.
Exporter fidelity
Auditor‑friendly ZIP/PDF with signatures & timestamps.
Under the hood
Platform primitives
Shared building blocks that power every module
Provenance, lineage, signatures, timestamps — tamper‑evident by default.
Data residency & PHI rules, allow/deny routing, audit logs.
Jira/Helix/Confluence/Git, EMR/PACS, PLC/SCADA/CMMS, mail/CSV/EDC.
Auditor‑ready ZIP/PDF, regulator XML/CSV, GSN diagrams.
FAQs
Frequently Asked Questions
Short answers to the questions compliance and IT ask first
Do you build the AI systems or only provide compliance tooling?
We build end to end AI and ML workflows for embedded devices, OT environments, and single tenant cloud deployments. Compliance, traceability, and validation evidence are included as part of every solution.
Can you deploy fully on-prem or air-gapped?
Yes. Our edge and embedded agents run without internet access. Cloud components can be deployed in your VPC, on-prem servers, or hybrid environments depending on IT and regulatory requirements.
How do projects usually start?
We begin with a short fit call to understand your use case, constraints, and regulatory expectations. Based on that discussion, we prepare a tailored approach for your team and environment.
Which industries do you support?
We work with regulated teams in healthcare, med-device, pharmaceuticals, biotechnology, manufacturing, automotive, aerospace, and other safety or quality critical sectors.
How do you handle privacy and data residency?
We follow PHIPA and PIPEDA aligned practices. Data can remain in Canada, in your VPC, or on your on-prem systems. We do not use client data to train shared or general purpose models.
Can you integrate with our existing systems?
Yes. We integrate with EMR and PACS systems, PLC and SCADA environments, CMMS platforms, Jira, Confluence, Git, sensors, and proprietary device telemetry. Connectors can be adapted to your infrastructure.
What security measures do you implement?
We support SSO and RBAC access controls, encrypted data flows, tamper evident logs, model and dataset lineage, and optional kill switches for edge and embedded agents.
Do you support bilingual workflows for Canadian organizations?
Yes. All documentation, audit artifacts, evaluation outputs, and redaction reports are available in English and French.
Do you help with funding or grants?
Yes. When relevant, we can help you prepare for programs such as SR&ED, IRAP, NGen, and Scale AI to support R and D or AI transformation initiatives.
Do you retrain or fine-tune models with our data?
We can, depending on your needs and regulatory obligations. Any model improvements or fine-tuning use your data exclusively and follow your privacy and residency requirements.
How long does a typical engagement take?
Timelines vary by complexity. Small embedded or cloud workflows can take a few weeks, while multi-system or regulated deployments may require longer. We scope timelines clearly after the fit call.
Let’s explore your use case together.
A short conversation to understand your workflows and identify what’s feasible.