Technology

AuraTrace™

Connect Quality and Vendor Governance.

AuraTrace™ is AuraGxP’s AI-enabled SaaS platform for managing regulated operations through one connected traceability model.

Bring quality, learning, vendor governance, contracts, milestones, and spend into a unified system—with greater traceability and real-time visibility.
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Two Connected Suites. One Platform.

Quality and Learning Management Suite
Complete quality management. From document control to inspection evidence.
Vendor Management and Governance Suite
From vendor selection to live risk scoring. One connected record.
Traceability Layer

Quality and Learning Management

Manage critical quality processes from document creation through inspection readiness.
  • Document Control
  • Learning Management
  • Audit Management
  • Change Control
  • Deviation Management
  • CAPA Management
  • Risk Management

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Vendor Management and Governance

Manage vendor relationships from selection and onboarding through performance and project spend reconciliation.
  • RFx Management and Evaluation
  • Vendor Onboarding
  • Contract Lifecycle Management
  • Order Tracking
  • Milestone Tracking
  • Delivery Feedback
  • Vendor Performance Monitoring
  • Project Spend Reconciliation
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Traceability Across Every Workflow

AuraTrace™ connects quality events, vendor records, contracts, milestones, performance, and spend through shared data and linked workflows.

A supplier audit finding can inform vendor risk, trigger corrective actions, affect sourcing decisions, and remain traceable through resolution.

One connected chain. One audit trail. Greater visibility into upstream causes and downstream impact.



AuraTrace™ unifies two critical pillars—Quality and Learning Management, and Vendor Management and Governance—within one intelligent platform built for life sciences and other regulated organizations.

From quality systems and training to vendor oversight, procurement, and spend visibility, AuraTrace™ delivers end-to-end control and traceability.
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Connected by Design

All of the AuraTrace modules have interconnected metadata resulting in a unified traceability model.
For instance, a single supplier audit finding can trigger connected actions across quality, training, vendor risk, sourcing, contracting, and spend—ensuring every decision reflects the latest compliance status.
That is one continuous chain, with one audit trail, queryable in either direction.
  • Ask what a given invoice ultimately traced back to and get an answer.
  • Ask what sits downstream of a given deviation and get an answer.

Designed to Support Compliance

AuraTrace™ is designed to support and comply with
applicable regulatory and industry expectations, including:
FDA 21 CFR Part 11
EU GMP Annex 11
ICH E6(R3)
Applicable ICH Q-series guidelines
ISO 9001
ISO 27001
SOC2
GDPR
ALCOA+ data integrity principles
GAMP 5 guidance

Compliance depends on configuration, validation, intended use, and your organization’s procedures.

Platform Differentiators

One Record Model, Not Thirty Integrations

Modules share the same objects, IDs, and audit trail. There is no sync lag, no reconciliation step, and no field-mapping document to validate.

Proprietary Risk Scoring Built for Regulated Supply

Vendor Risk Score (VRS), Rescue Risk Score (RRS), and the Inspection Readiness Score (IIRS) convert scattered qualification, performance, and quality signals into a single monitored number recalculated as the underlying records change, not at quarterly review.

Configuration Without a Revalidation Cascade

Document types and picklist values across all modules are configured, not coded. Configuration changes are captured under change control with their own audit trail.

Purpose-built, Not Adapted

Not a horizontal ERP or workflow tool with a GxP layer added. Part 11, Annex 11, ALCOA+, and GAMP 5 expectations are embedded in the data model.

One Connected Traceability Model

Quality, learning, vendor, and spend records share common data and relationships—reducing disconnected workflows and manual reconciliation.

End-to-End Traceability

Connect deviations, CAPAs, findings, changes, vendors, contracts, milestones, and contract amendments to their sources and outcomes.

Dynamic Risk Visibility

Bring qualification, performance, quality, and operational signals together to support earlier, better-informed decisions.

Configurable Workflows

Configure document types, fields, approvals, and workflows to reflect your operating model and change-control requirements.

Built for Regulated Operations

AuraTrace™ is designed for life sciences and other regulated organizations, with data integrity, auditability, and human accountability at its core.

AI-Enabled, Human-Governed

Use intelligent automation and decision support while keeping expert review, approval, and accountability with your team.

FAQ

Frequently Asked Questions

Helping teams navigate implementation and quality with confidence.

AuraTrace™ is provided as an online, non-downloadable Software-as-a-Service (SaaS) platform for managing quality, procurement, vendor oversight, and spend in regulated industries.