Coverage aligned to Part 11 requirements across electronic records and signatures
Auryis
Unified, AI-enabled
Compliance Assessment Platform
AI-Powered Regulatory Assessments
Achieve and sustain compliance with confidence. Auryis scans your SOPs, policies, and procedures to identify, explain, and prioritize risks—then routes every finding through the Expert Hub, a panel of Subject Matter Experts, for validation. With thousands of built-in assessment rules plus your company-specific, best-practice, and assessment-specific custom rules, Auryis delivers faster, clearer, and auditable decisions that steadily improve your compliance profile
Who It’s For
Pharma QA/RA leaders, Compliance Officers, IT/CSV teams, and internal auditors who need to demonstrate readiness against 21 CFR Part 11 and beyond.
Key Outcomes
Be audit-ready sooner by turning unstructured documentation into traceable,defensible evidence
Reduce exposure to findings and rework with prioritized, probability/impact-scored risks
Improve continuously as Expert Hub validations feed back into the rules engine
How Auryis Works
Document intelligence
Ingest and parse SOPs, policies, procedures, validation documentation, and system records
Ingest and parse SOPs, policies, procedures, validation documentation, and system records
AI risk detection
Map content to regulatory requirements and flag risky passages with rationale, probability, and impact
Map content to regulatory requirements and flag risky passages with rationale, probability, and impact
Expert Hub validation
Subject Matter Experts confirm, dismiss, or refine findings, adding context and remediation guidance
Subject Matter Experts confirm, dismiss, or refine findings, adding context and remediation guidance
Continuous learning
SME feedback updates the rules engine, improving precision and recall over time
SME feedback updates the rules engine, improving precision and recall over time
Configurable rules
Layer company-specific controls, industry best practices, and assessment-specific custom rules
Layer company-specific controls, industry best practices, and assessment-specific custom rules
Built for Pharma (21 CFR Part 11)
Clear traceability from requirement to evidence to decision, with versioned rule sets and SME sign-offs
Consistent, repeatable assessments across sites, systems, and document versions
Features
Three-level reporting
Executive summary, consolidated risk details, and document-wise breakdowns.
Highlighted evidence
Pinpointed excerpts in documents with explanations and citations
Priority and remediation
Likelihood/impact scoring, recommended actions, and ownership tracking
Compliance profiles over time
Trendlines and deltas across assessment iterations
Audit-ready pack
Decision logs, rationale, SME validations, and exportable reports
Rules flexibility
Company-specific, industry best practice, and custom assessment rules
Governance
Rule versioning, change control, and approval workflows.
Multilingual document support
Roadmap to assess global sites consistently.
Expert Hub
The Expert Hub is your panel of Subject Matter Experts integrated directly into the assessment workflow. SMEs validate risks, add context, and guide remediation—closing the loop between AI detection and real-world judgment. Their feedback continuously updates the rules engine, ensuring Auryis reflects evolving practices and regulatory expectations
Security and Compliance
Role-based access controls with least-privilege principles
Full activity audit trails for documents, rules, and decisions
Data minimization, secure storage, and configurable retention
Alignment with pharma QA/QMS expectations and CSV best practices
Integrations
Connect Auryis to your document repositories, QMS/EDMS, and GRC systems to automate evidence collection and streamline remediation tracking. Rich APIs and prebuilt connectors (roadmap) make it easy to fit into your landscape
Roadmap
Expanding coverage to Pharmacovigilance, then banking and insurance regulations; automated evidence mapping and end-to-end traceability; SME-assisted rule authoring with governance; benchmark and predictive risk analytics; multilingual document support; rich APIs and QMS/GRC integrations; enhanced auditor-ready reporting packs; and continuous updates driven by Expert Hub validations and emerging standards
Measurable Value
Faster readiness: compress reviews from weeks to days
Higher confidence: improved detection accuracy through Expert Hub validation
Lower risk: earlier issue detection reduces findings and remediation effort
Implementation
Rapid onboarding: connect repositories, import documents, and run a baseline assessment
Tailor to your operations: apply company-specific and best-practice rules
Calibrate SMEs: establish Expert Hub reviewers, cadence, and approval criteria
About Canarys Automations Limited
Auryis is developed by Canarys Automations Limited—an innovative products and solutions company with 33 years of cross-domain experience. Auryis has enabled Canarys to transition from services to a product-led model, bringing deep domain expertise and a rigorous approach to regulated industries
