Technology

auraTrace™

AuraTrace™ is AuraGxP’s flagship SaaS platform - one connected software for regulated operations.

AuraGxP's Flagship SaaS Platform

One Unified Software That Connects Every Quality, Procurement, Vendor Oversight, And Spend Workflow—And Provides Real-time Visibility.

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In regulated industries, growth fragments systems, disconnects processes, and compounds compliance overhead. Quality records live in one application, procurement data in another, vendor documentation in spreadsheets, and spend information across multiple tools.

The result is duplicated effort, inconsistent data, delayed decisions - and a regulatory risk profile nobody can see whole.

Quality & Learning Management Suite

Complete quality management. From document control to inspection evidence.

Procurement & Vendor Management Suite

From vendor selection to live risk scoring. One connected record.

Spend Management Suite

Budget clarity connected to quality & vendor reality.

Traceability Layer

AuraTrace™ brings these critical business functions together within a single intelligent platform designed specifically for life sciences, clinical research, biotechnology, and pharmaceutical companies, as well as other regulated organizations.

From quality management and supplier governance to procurement operations and financial visibility, AuraTrace™ provides end-to-end process control.

The platform is built to support compliance with applicable regulations, standards, guidelines, and data integrity principles, such as FDA 21 CFR Part 11, EU GMP Annex 11, ICH E6 (R3) Good Clinical Practice, ICH Q(7-12), ISO 9001, ISO 13485, and applicable ALCOA+ data integrity principles.

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Connected By Design, Not By Integration

Most platforms connect modules with integrations. AuraTrace™ instead has interconnected metadata resulting in a unified record 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.

Platform Features

1 Record Model

Single record model across quality, procurement, and spend — not integrations between three systems

100% Traceability

100% Linked: Every deviation, CAPA, finding, and change connected to its source and its downstream effect

ZERO Reconciliations

Zero reconciliations between Quality, Procurement and Finance records

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.

AuraTrace™ Implementation Timeline

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.