Quality and Learning Management

Quality and Learning Management Suite

Build quality into every process, not just every audit.

Why Use AuraTrace™ Quality and Learning Management Suite?

Compliance takes more than documenting quality events after they happen. AuraTrace™ connects documents, training, investigations, CAPAs, and audits on one record, so every workflow is traceable, version-controlled, and audit ready.

Three Pillars. Everything You Need to Manage Quality and Learning.

Three pillars, each built from modules that share one record. Select a pillar to jump to its modules.

Quality Compliance

Controlled documents and a full learning management system, on one record.

Today

Retraining identified by hand when a procedure changes
Curricula, learner records, and certifications reconciled manually
Audit evidence exported from several systems

With AuraTrace™

Event-based retraining when an SOP changes
Traceability: SOP version → curriculum → learner → assessment → qualification
Spreadsheet training matrices retired

Training that cannot drift from the SOP set. Most organizations run document control and training as two systems reconciled by a person. AuraTrace™ links both in one platform, so "who was trained on this revision, and when?" takes seconds.

Quality Compliance Modules

Module

Document Management

Controlled documents with versioning, review and approval routing, Part 11 e-signatures, and full audit trails.

SOPsWork InstructionsCVs

Module

Learning Management

Role-based training, competency tracking, retraining, and certifications tied to the current SOP revision.

Curriculum ManagementLearner AdministrationSOP, HR, GxP, and Project-Level Training

Quality Assurance

Structured workflows for every quality event, from change to closure.

Today

CAPAs lose sight of the originating deviation
Changes disconnected from corrective actions
Effectiveness checks overlooked

With AuraTrace™

Create CAPAs directly from deviations
End-to-end traceability from event to remediation
Automated effectiveness follow-up

Deviations that reach into procurement. When a deviation involves a supplied material or vendor service, it links to the vendor, the qualification audit, the contract, and the purchase order. A pure QMS can't make that link; a pure procurement tool can't see the deviation.

Quality Assurance Modules

Module

Change Control

Evaluate, approve, implement, and verify changes, with impact on documents, training, and suppliers assessed up front.

Module

CAPA Management

Corrective and preventive actions from root cause through effectiveness verification.

Module

Deviation Management

Capture, investigate, and resolve deviations, linked to CAPAs, risks, training, and documents.

Module

Risk Management

Assess, prioritize, and monitor quality risks in line with ICH Q9.

Module

Complaints Management

Investigate, trend, and resolve complaints, traced to the deviations, CAPAs, and vendors involved.

Module

Quality Events

Triage events that don't yet fit a record type, then promote them without re-entering data.

Inspection Readiness

Audits, findings, and evidence in one suite, ready on demand.

Today

"Show me the finding, evidence, CAPA, and closure" becomes a project
The evidence trail is a mailbox
Readiness is rebuilt before every inspection

With AuraTrace™

The full inspection story from observation to closure
Email-based evidence collection retired
Faster responses to inspectors

Bidirectional chain, both directions traceable. AuraTrace™ tracks upstream from any record to its root cause, and downstream from any root cause to everything it touched.

Inspection Readiness Modules

Module

Audit Management

Plan, run, and close internal, supplier, and regulatory audits, with every finding carried to its CAPA.

FindingsAnnual Audit PlannerRole-Based Audit Room

Linked

Every audit finding tied to its CAPA, and every CAPA back to its source.

Current

No one works from a superseded SOP revision.

Trained

SOP version to learner qualification, traced in one record.

Ready

Inspection evidence on demand, not rebuilt before each visit.

See It on Your Own Records.

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Frequently Asked Questions

Helping teams navigate implementation and Quality with confidence.