AuraGxP's flagship platform - AuraTrace™
AuraGxP runs your procurement and vendor management function so that compliance, quality, and performance stay in lockstep — from your first vendor contract to your last clinical milestone.
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One Platform That Connects Every Quality, Procurement, Vendor Oversight, and Spend Workflow & Provides Real-time Visibility.
In regulated industries, growth often leads to fragmented systems, disconnected processes, and increasing 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 unnecessary regulatory risk.
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 while supporting compliance with applicable regulations, standards, guidelines, and data integrity principles, including FDA 21 CFR Part 11, GxP guidelines, EU GMP Annex 11, ICH E6 (R3) Good Clinical Practice, ISO 9001, ISO 13485, and applicable ALCOA+ data integrity principles.
Build Quality Into Every Process. Not Just Every Audit.
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Manage controlled documents throughout their entire lifecycle with automated version control, review workflows, approval routing, electronic signatures, and complete audit trails.
AuraTrace™ helps organizations maintain compliant documentation aligned with 21 CFR Part 11, EU Annex 11, and GxP documentation requirements while ensuring teams always work from the latest approved version.
Ensure every employee, contractor, and vendor is trained on the right procedures at the right time.
AuraTrace™ automates role-based training assignments, competency tracking, retraining schedules, certification management, and training records to support inspection readiness and continuous compliance.
Plan, conduct, document, and monitor internal, external, supplier, and regulatory audits from one centralized platform.
Manage audit schedules, observations, findings, evidence, corrective actions, and closure activities with complete visibility across the organization.
Standardize how operational, procedural, process, and system changes are evaluated, approved, implemented, and verified.
Integrated impact assessments, approvals, and change histories help organizations maintain controlled environments while reducing regulatory risk.
Capture, investigate, classify, and resolve deviations through structured workflows that improve consistency and accelerate resolution.
Connected investigations ensure that deviations are seamlessly linked to CAPAs, risk assessments, training requirements, and quality documentation.
Manage the complete lifecycle of Corrective and Preventive Actions (CAPA) from initiation through effectiveness verification.
AuraTrace™ helps organizations identify root causes, define CAPA, assign ownership, monitor implementation, and demonstrate continuous improvement during inspections.
Identify, assess, prioritize, and continuously monitor operational and quality risks using structured risk assessment methodologies.
AuraTrace™ enables proactive risk mitigation while supporting quality risk management principles outlined within ICH Q9 and broader GxP expectations.
A future release will include comprehensive complaint management capabilities that enable organizations to record, investigate, analyze trends, escalate, and resolve customer, product, and service complaints while maintaining complete regulatory traceability.
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