TraceX eQMS next gen features

TraceX eQMS will improve efficiency and quality with real-time collaboration on controlled documents, electronic signature (21 CFR part 11, FDA compliant), PDF export, product management and training & qualification.

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Key benefits

Improve collaboration on controlled documentationThe real-time collaboration documentation integrates version control and access management features, ensuring that only authorized individuals can review or approve the documents.

Easily monitor trainings & qualificationsThis module allows for the easy assignment, tracking, and monitoring of required training courses and qualifications, providing real-time visibility into each employee's progress.

Simplify compliance adherenceIt simplifies compliance with regulations (e.g. ISO 13485 and 21 CFR Part 11) by automating quality management processes and by ensuring all activities are recorded with secure electronic signatures and audit trails.

TraceX eQMS features

Documentation management

Real-time collaboration to create, review and approve documents (quality & technical documents).

Change control management

Streamline the evaluation, approval, and tracking of changes to ensure compliance and reduce risks.

Electronic signature

Benefit from electronic signature module 21 CFR Part 11 compliant (FDA).

Quality events management

Manage company events from identification and investigation to resolution (e.g. Issues, Non-Conformity, CAPAs, etc.).

Training and qualification

Enjoy real-time visibility into each employee's qualification progress.

Audit readiness

If requested by the auditor, export PDF versions of controlled documents with the signature certificate and other necessary information.

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