Auryis | AI-enabled Compliance Platform for 21 CFR Part 11
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Auryis Lifesciences Quality Intelligence.

Compliance at the Speed of Innovation — regulatory-grade AI compliance built for pharma and life sciences.

Overview

What is Auryis Quality Intelligence.

Auryis Lifesciences — QI is a regulatory-grade AI compliance platform built for pharmaceutical and life sciences organizations. It brings together advanced AI and domain expertise to deliver continuous audit readiness, faster validation, and stronger quality assurance — eliminating manual, reactive processes.

At its core, Auryis QI leverages Pharma-specific intelligence to understand regulatory intent, automate complex validation processes, and provide end-to-end traceability across the compliance lifecycle. By shifting from manual, reactive workflows to a proactive, intelligence-driven approach, it empowers organizations to identify risks early, ensure consistency, and maintain audit-ready operations at all times.

With Auryis QI, quality is no longer a checkpoint — it becomes a continuous, scalable, and strategic capability that drives efficiency, reduces risk, and accelerates time-to-market.

Why Auryis

Turn Compliance into a Strategic Advantage.

Break free from manual, reactive processes. Auryis QI uses domain-trained AI to accelerate validation, eliminate inefficiencies, and surface risks before regulators do — so you stay audit-ready, always.

Faster Time-to-Market

Accelerate validation with automated analysis and gap detection — freeing QA teams for high-value decisions.

Always Audit-Ready

Move from reactive audits to continuous compliance with real-time readiness across products and sites.

Proactive Risk Reduction

Identify and resolve compliance gaps early with predictive pre-audit insights — before findings escalate.

Consistency at Scale

Standardize regulatory processes across products, sites, and teams — eliminating variability in execution.

Reduced SME Effort

Minimize manual review work, enabling experts to focus on validation and critical decisions.

Continuous Quality Assurance

Quality becomes a continuous, scalable, and strategic capability — driving efficiency and reducing risk.

Capabilities

Key Capabilities & Features.

Six purpose-built capabilities that convert regulatory complexity into a clear, traceable, and explainable workflow — from intent to evidence.

Pharma-Specific SpLM

Regulatory-trained AI delivering precise, explainable insights tuned to pharma intent.

Intelligent Business Rules Engine

Applies contextual logic across documents for accurate, repeatable compliance evaluation.

End-to-End Traceability

Links requirements, specifications, tests, and evidence seamlessly across the compliance lifecycle.

Pre-Audit Simulation

Predicts risks early to prevent audit findings before they become formal observations.

Xpert Hub (Human-in-the-Loop)

AI plus expert validation — working together for accurate, auditable outcomes.

Secure Collaboration

Built-in PII masking and role-aware access for safe, compliant data handling at scale.

Validation-Ready Outputs

Traceable, explainable, and audit-compliant by design — no rework before submission.

Engagement

Sales Engagement Model.

A structured, consultative journey designed to demonstrate measurable value at every stage — from first contact through to enterprise deployment and ongoing partnership.

01 · Discover & Align

We start by understanding your regulatory landscape, current quality posture, and the most painful gaps in your validation and audit workflows. The goal: a shared view of where Auryis QI moves the needle.

  • Stakeholder workshops with QA, RA, and IT leaders
  • Compliance maturity & audit-readiness baseline
  • Priority use-case identification and ROI hypothesis

02 · Demo & Validate

A tailored demonstration of Auryis QI against your real-world scenarios. We showcase how the platform handles your documents, regulations, and validation rules — proving fit before you commit.

  • Custom-tailored product walkthrough with your data samples
  • Use-case validation against your SOPs and protocols
  • Technical & security architecture deep-dive

03 · Proof of Value

A time-boxed pilot where Auryis QI runs against a real workload from your environment. We measure the impact — speed, accuracy, SME hours saved — so the business case writes itself.

  • Bounded pilot scope with defined success metrics
  • Side-by-side comparison vs. current manual process
  • Quantified ROI report & executive readout

04 · Deploy & Grow

Enterprise deployment with white-glove onboarding, then a long-term partnership focused on continuous improvement, expansion to new use-cases, and quarterly value reviews.

  • Production deployment with integration to your QMS & eDMS
  • Role-based training & change-management support
  • Dedicated success manager & quarterly business reviews
Industries

Industries we serve.

Auryis QI is purpose-built for organizations where compliance is non-negotiable — starting with the most regulated corner of the world: life sciences.

Primary focus — Pharmaceuticals & Life Sciences. Auryis QI is engineered around the validation, audit, and quality workflows that define modern pharma. From IND through commercial release — accelerate every stage without compromising regulatory rigor.

Biotechnology

Bring novel therapies to market faster with regulatory-grade quality intelligence tuned for biologics and advanced therapeutics.

Medical Devices

Standardize design controls and traceability across products, sites, and teams.

Clinical Research

Enforce protocol integrity, automate review, and reduce SME time across trials.

Contract Manufacturing

Maintain consistent compliance across multi-site, multi-client CDMO operations.

Healthcare

Ensure continuous quality assurance with predictive risk insights at the point of care.

Why Auryis

Why Auryis for your compliance journey?

Domain-Trained AI

Models grounded in pharma regulatory frameworks, not generic LLMs.

Continuous Audit Readiness

Move from reactive audits to real-time, always-on compliance.

Outcome-Focused

Every engagement tied to measurable QA and audit-readiness KPIs.

Built-in Security & Privacy

PII masking and role-aware access for safe, compliant data handling.

Backed by Canarys

30+ years of regulated-industry delivery across pharma, BFSI, and healthcare.

Get in touch

Make Compliance Your Competitive Edge.

Whether you’re modernizing validation, automating audits, or scaling quality across global sites — Auryis is built to make compliance simple, predictive, and continuous.

With Canarys, let’s plan, grow, strive, succeed.

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