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The Less Stress QMS Software for Quality Teams

ZenQMS is trusted by organizations of all sizes and industries to help control quality and stay compliant. 

With ZenQMS, you can: 

  • Automate routine tasks like training assignments and review reminders
  • Change and adapt your workflows as your organization scales without the need for IT support
  • View your entire risk management process for end-to-end traceability
  • Meet the highest regulatory standards with SOC II, ISO 27001, ISO 9001, GDPR, 21 CFR Part 11/ Annex 11, and HIPAA compliance.
  • Impress stakeholders with real-time reports, automatic audit trails, and easy-to-read quality data dashboards

In addition to biopharma orgs, CROs, manufacturers, logistics, and laboratories,

we also serve organizations operating in these industries:

 

Medical Device

GxP Software

Cell and Gene Therapy

Aviation

Consumer Products

Documents

Safeguard quality with document control software that:

  • Allows for fast, easy document retrieval through Keyword Search, SOP linking, etc.
  • Automates and enforces your unique approval workflows for any type of document
  • Keeps you inspection-ready with clear, automatic audit trails
  • Is 21 CFR Part 11/ Annex 11 compliant for all electronic signatures
  • Strengthens document control with granular user access permissions

Documents Full Table

 

Training

Improve compliance with training management software that:

  • Provides company-wide training status with quick, simple dashboards
  • Automates training assignments through courses and roles
  • Automates reminders for new and past-due assignments
  • Easily logs all training types, including SOP reviews, group training, OJTs, and personal events
  • Allows for automatic retraining triggers after major document revisions
  • Provides access to expert-authored GMP, GLP, and GCP training content integrated directly in the system” with “training content”

Training on a Document

 

Issues

Control your quality events with audit-ready issues management software that: 

  • Manages CAPAs, deviations, and complaints with just a few clicks
  • Provides detailed issues data & reports, including top issue categories, time to final stage, average on-time completion, and more
  • Automates issue notifications and investigator assignments
  • Links issues and deviations to CAPAs for closed-loop traceability

Issues Dashboard

 

Change Control

Manage change without the headaches with a change control management software that:

  • Tracks critical data like on-time and over-due change control implementation
  • Allows you to configure change control stages and categories to match your SOPs
  • Reduces audit times with an integrated, easy-to-navigate interface that regulators understand
  • Enforces detailed user permissions for access and escalation

Change Control Dashboard

 

Audit

Stay audit-ready with audit management software that: 

  • Automatically tracks upcoming audit due dates for any certifications and standards you need to maintain
  • Creates detailed list of approved vendors and suppliers with easy access to Q sheets
  • Tracks audit observations and steps taken to close
  • Easily pulls reports with critical data like total observations, on-time completion percentage, audit state, and more

Audits Dashboard

 

Insights

Get actionable insights with quality data reporting software that:

  • Identifies and analyzes KPIs on document control, training, issues, audits, and more 
  • Exports report dashboards to PDF for easy sharing
  • Showcases quality’s impact on resource protection, revenue, and continuous improvement

Insights (1)

 

ZenSign

Make compliance your signature move with our built-in eSignature tool.

  • Seamless Part-11 compliant eSignature to manage clients, vendors, and more
  • Already validated and integrated directly into ZenQMS
  • Secure closed workflow: documents and content never leave the system
  • X.509 certificate built in

zensign gif

 

“The main quantifiable benefit is audit-readiness. I want to be able to find my records in one system, not four or five different places. I don’t have to worry about that. I know that ZenQMS is my single source of truth.”
Kirsten WestrateSQ Innovation
"ZenQMS is an extremely user-friendly system. It’s easily configurable with an extensive support team readily available at a reasonable cost.”
Sophia AchuffassisTek
“[ZenQMS] is a quality system for quality professionals, built by quality professionals, with quality management principles at the forefront, and that's not typically the case.”
Kristyn SamaClarivate
“The key thing about ZenQMS is that you can configure workflows without added support from an in-house IT team.”
Jennifer HaganOmega Therapeutics