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
Start with a tiny wedge. Stack modules over time. Everything exports regulator‑ and auditor‑ready artifacts.
Generate PCCPs, AI‑SBOMs, and bilingual eval scorecards. Evidence, not slides.
One‑click Audit Packs from Jira/Helix/Confluence/Git with e‑signatures, timestamps, and lineage.
Ingest adverse events & service logs, deduplicate signals, draft CAPA stubs, export to regulators.
Run LLM/vision flows fully on‑prem or VPC. Policy sandbox, kill‑switch, and IT‑approved telemetry.
Rare‑failure generators and EN/FR stress‑tests to prove robustness without exposing PHI.
Data residency (CA), PHIPA/PIPEDA alignment, bilingual outputs. Auditor‑friendly by design.
Connect tools for Project Management/Application Lifecycle Management/Code Management/Knowledgebases or EMR/CMMS in a scoped sandbox.
PCCP + AI‑SBOM + Audit Pack with cross‑links, signatures, and lineage.
Keep the pack, expand to subscriptions, or pause — no long commitments.
Private by default
Policy‑sandboxed LLM/vision flows. No internet required, kill‑switch included.
PLC/SCADA, PACS/EMR, cameras, CMMS. Start with your highest‑value flow.
Immutable logs: prompts, model hashes, decisions, and redactions.
EN/FR PHI scrubbing and re‑ID risk reports for privacy reviews.
Push‑button proof
Requirements → risks (FMEA/CAPA) → tests → release, all cross‑linked.
Auto‑draft assurance cases with goal structuring notation.
Commits and test failures nudge updates to FMEA/CAPA docs.
Auditor‑friendly ZIP/PDF with signatures & timestamps.
Under the hood
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.
Implementation notes, compliance checklists, and lessons from Evidence Sprints. New posts added as the suite evolves.
Practical playbook for Canadian and US regulated teams to turn AI pilots into audit-ready, production systems by embedding governance, evidence, and monitoring from day one.
FAQs
Short answers to the questions compliance and IT ask first
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.
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.
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.
We work with regulated teams in healthcare, med-device, pharmaceuticals, biotechnology, manufacturing, automotive, aerospace, and other safety or quality critical sectors.
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.
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.
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.
Yes. All documentation, audit artifacts, evaluation outputs, and redaction reports are available in English and French.
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.
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.
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.
A short conversation to understand your workflows and identify what’s feasible.
