Overview

Quality is having all your docs in a row.

Replace spreadsheets and disconnected tools with one connected, cloud-based QMS. Qtes eQMS gives your quality team a single place to create, distribute, archive and govern controlled documents — and the workflows that make them mean something.

Modules: File Control · Change Control · Training Management System · CAPA · Deviation Management · Audit Management.

  • Collaborative, cloud-based document control — anytime, anywhere access for distributed teams
  • Create, distribute and archive all controlled documents in a single location
  • Define workflows for procedures and processes — draft, review, approve and make controlled changes
  • Role-based access, electronic signatures and 21 CFR Part 11-aligned audit trails
  • End-to-end view of your quality assurance process across every controlled document
  • Integrates with the rest of the Qtes Soft suite — eCTD submissions, Qtes ePI & eSPL Builder, BPM workflows
Request a Qtes eQMS demo
Qtes eQMS

Quality is having all your docs in a row.

Replace spreadsheets and disconnected tools with one connected, cloud-based QMS.

Cloud
Anytime, anywhere
Part 11
21 CFR-aligned
360°
Audit-trail coverage
ISO
9001 & 13485 aligned
QMS modules

A modular quality system

Activate the modules you need today and grow into the rest. Every module shares one identity model, one audit trail, and one set of dashboards.

File Control

SOP, policy and controlled-document lifecycle — authoring, review, periodic review, controlled distribution and electronic signatures.

Training Management System

Role-based training assignments tied to SOP revisions, with quizzes, competency tracking and read-and-understood evidence.

Deviation Management

Capture, classify and investigate deviations and non-conformances — with linked root-cause analysis and impact assessment.

CAPA Management

Corrective and preventive actions with ownership, due-date tracking, effectiveness checks and trending across the organization.

Change Control

Risk-assessed change requests with cross-functional review, linked impact analysis, and traceability into deviations and CAPAs.

Audit Management

Plan and run internal and supplier audits — record findings, assign actions, and verify effectiveness in one connected workflow.

More from Qtes Soft

Other products in the suite

Each product works standalone — or connects to share data, governance and audit trails across your regulatory and quality teams.

Qtes eCTD Builder

Qtes eCTD Builder

An integrated suite for creation, manipulation, validation, publishing and viewing of eCTD dossiers — for FDA, EMA, GCC and emerging-market authorities.

Learn more →

Qtes ePI & eSPL Builder

Qtes ePI & eSPL Builder

Structured authoring and publishing for electronic Product Information and FDA Structured Product Labeling — leaflets, SmPCs, package inserts and labels.

Learn more →

See Qtes eQMS in action

Book a walkthrough of the modules and workflows that matter to your quality team.

Request a demo