Quality & Learning Management Suite

Manage controlled documents throughout their entire lifecycle with automated version control, review workflows, approval routing, regulatory compliant electronic signatures, and complete audit trails.

AuraTrace™ helps organizations maintain compliant documentation aligned with 21 CFR Part 11, EU Annex 11, and other GxP documentation requirements while ensuring teams always work from the latest approved version.

Every controlled document links to the change controls that revised it, the training assignments it generated, and the deviations, CAPAs, and audits that reference it.

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 – so that answer to “who was trained on this revision, and when?” takes seconds.

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.

Every finding carries forward to its CAPA, and every CAPA back to the finding, the auditor, and the evidence – across internal, supplier and regulatory audits alike.

Standardize how operational, procedural, process, and system changes are evaluated, approved, implemented, and verified.

Integrated impact assessments identify affected documents, training, and suppliers before approvals - not after implementation.

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.