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SolutioneQMS

Unleash your capabilities with TraceX eQMS

No more paper or Microsoft Word documents! TraceX is a next generation, fully digital eQMS (electronic Quality Management System) that enables you to track Quality Events, Training and Qualification, Documentation Control and ensure compliance.

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TraceX eQMS Key Benefits

Reduce time spent on technical documentationTraceX is 100% digital solution that enables you to create, review, and sign a document fully online, eliminating the need to download and upload the document at each review.
Document creation with the click of a buttonTraceX automatically generates documents (Traceability Matrix, test reports, requirements, specifications, etc.) automatically generated from the integrated Task Tracker.
Reduce time spent preparing for auditsTraceX enables tracking and sends reminder for due dates (e.g; for Quality Events, Training and Qualification, etc.), ensuring your company is up to date for audits at any time.
Compliance at every stepTraceX enables you to follow the norms, e.g. ISO 1385, IEC 62304 as well as being 21 CFR part 11 compliant for electronic records and signatures.
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TraceX eQMS functionalities

Quality events management

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

Documentation control

Create, collaborate and sign documentation (Quality docs or records) easily online.

Training and qualification

Create trainings and assign them for trainees to complete.

Audit readiness

Enable to exports audit trail, CAPAs lists, Training and Qualifications records, and any other metrics needed for audit purposes.

Integrated Task Tracker

No need to enter your information twice. Your information is automatically generated from the Task Tracker for requirements, specifications, test cases, and more.

Compliance

Benefit from review and approval process as well as a 21 CFR Part 11 e-signature.

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