SolutioneQMS

Unleash your capabilities with TraceX eQMS

No more paper nor Microsoft Word based. TraceX is a New Generation, fully digital eQMS (electronic Quality Management System) that enables you to track Quality Events, Training / Qualification, Documentation Control and ensure compliance.

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TraceX eQMS Key Benefits

Reduce time of work on a technical documentTraceX is 100% digital solution that enables you to create, review, sign a document fully online, removing the need to download / upload the document at each review
Document creation on the click of a buttonTraceX automatically generates the documents (Traceability Matrix, Test report, Requirement, Specifications) are automatically generated from the integrated Task Tracker
Reduction in time to prepare for AuditTraceX enables tracking, and sends reminder for everything (e.g; for Quality Events, Training Qualification, ...) due dates which makes your company up to date for audits at anytime
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 companies events from identification, investigation to resolution (e.g. Issues, Non-Conformity, CAPAs, ..)

Documentation Control

Create, collaborate and sign documentation (Quality docs or records) 100% online and very easily

Training and Qualifications

Create trainings and assign them. The trainees can on their end take their training

Audit readiness

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

Integrated Task Tracker

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

Compliance

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

Do you want more information?

We would love hear from you and to show you the solution.

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