Experience a connected
quality management system

ZenQMS integrates all of your critical-to-quality documents and events

A seamless quality platform where awesome comes standard

  • Purpose-built for 21 CFR Pt.11/ Annex 11 and relevant GxP/ ISO requirements   
  • All modules integrated and each module works together to configure around your process
  • Instant access to all modules for all your staff.  


Updated doc-1

Manage the full document lifecycle from draft to retirement

Document management that is compliant, simple, and accessible

  • Enforce workflows that actually match your current processes 
  • Set access rights based on user roles/ permissions
  • Quickly find data with Global Keyword Search even within documents
  • Automate periodic reviews of lifecycle structure
  • Part 11/ Annex 11 compliant signatures built-in
Training Module

Intuitively create, track, and complete training

Track and prompt training on documents, videos, tests and live events

  • Author and enforce role-based training curriculum on the fly
  • Automatic email reminders for new and interval training
  • Produce detailed, instant reporting by curricula, role, training item type or person
Training Screenshot
Issues Web-1
Issues Module

Address Deviations and CAPAs your way

Build custom, closed-loop processes for any event type

  • Design multi-stage process with custom electronic and workflows 
  • Include stages for root cause analyses and effectiveness checks
  • Automate issue notifications and investigator assignments
  • Create dashboards to measure process throughput and activity 

Keep your finger on the pulse of change

Create and enforce custom change management processes for any department

  • Configure forms and stages to match your current processes
  • Assign granular permissions for access and escalation
  • Ensure follow-up by creating/managing sub-tasks for each stage
Change Control web-2
Audits web

Streamline your entire GxP audit and supplier qualification process

Organize audits from planning to execution

  • Easily call up an approved vendor list 
  • Set an evergreen audit calendar to update as you work 
  • Ensure a feedback loop in your risk management with reports and trends 

Reliable, secure data

100% Pure SaaS from birth
ZenQMS is built with a pure SaaS infrastructure from the ground up, which means that you always have automatic access to each new release with no IT requirements to manage.

Our single validated, multi-tenant instance in the cloud (Amazon Web Services) has a guaranteed uptime > 99.99% and expedited validation gameplan that anyone can execute.

Data Security and Transparency
ZenQMS maintains defined and tested procedures for business continuity and disruption. Your data gets backed up hourly and you have the ability to export your entire account locally as a zip file on a regular basis for added protection.

Committed to your success

Quality is not optional, and we believe it should be everyone's business. So, we've flipped the model from complexity and cost to lifetime support and simple, transparent enterprise pricing.

Support should be personal, helpful, and free. 
Support starts with personalized implementation, including a guided validation checklist, and continues for your lifetime at ZenQMS. Access to our helpdesk and ZenQMS training material (including our knowledge base) are all included as part of your annual fee--no surprises or per call hour fees for help. 

Your voice and experience matters to us. We build our product roadmap in collaboration with our customers. As part of the ZenQMS community, you will have access to our upcoming developments and a forum for suggesting new features.

Simple, transparent pricing

Our customers see a clear cost of ownership and no surprise charges for storage, support, seat licenses, etc. 

When you invest in ZenQMS, you have access to the entire system for your whole company without exception. Rather than charging per module, all our modules and updates come standard.

Worrying about seat licenses means that you have pay for growth. We believe that you can’t afford to silo quality, so we don’t charge per seat licenses. Let's grow together. 

Ready to control quality?