Product Overview

The flexible, all-in-one eQMS for Life Sciences & GxP-regulated companies

With ZenQMS, awesome comes standard.

An integrated eQMS that teams actually like to use, with each module configured to mirror YOUR processes
Instant access to all modules for all team members from day one
We flipped the script with our pricing and support model, so your quality system can grow with your team
Purpose-built for Life Sciences companies
Validated for 21 CFR Pt.11/ Annex 11 and relevant GxP/ ISO requirements

Training Module

See training status at a glance with our simple dashboard

No more chasing down your team when training is due - users get automated reminders of new and past-due assignments
Easily create, complete, and track training from SOP reviews to on-the-job events
Pull training reports by individual, course, or group
Drive robust training and testing with SCORM file support

More About Training

Understand training status in a glance and take training right in your login screen

Quickly find and edit documents collaboratively

Documents Module

Track the document lifecycle from draft to retirement

Stay 21 CFR Part 11/ Annex 11 compliant for all electronic signatures
Edit documents collaboratively with other stakeholders
Establish document control through granular permissions
Create both major and minor document revisions
Search data, even within documents, using the Keyword Search feature

More About Doc Management

Change Control

Manage organizational change in a controlled state

Keep an accurate record of change within your organization
Build follow-up tasks directly into your process so change is actionable
Assign detailed permissions for access and escalation
Reduce audit times with our straightforward interface that regulators understand
Automatically enforce closed-loop processes
Easily demonstrate your controlled state to auditors

More About Change Control

Change control engines allows you to easily configure around your processes / forms

Create and enforce any process easily

Issues Module

Report, address, and resolve issues without the headache

Manage CAPAs, deviations, complaints, and your quality control process with just a few clicks
Build custom, closed-loop workflows that match your processes for any event type
Automate issue notifications and investigator assignments
Create dashboards to measure quality event progress and activity

More About Issues

Audits Module

Simplify your entire GxP audit and supplier qualification process

Create and track lists of approved suppliers
Monitor observations to closer
Set an evergreen audit calendar to update as you work
Establish a feedback loop for risk management with reports and trends

More About Audits

View a list of your active & approved vendors in two clicks

Insights Module

Get actionable insights from your quality data

Identify and analyze trend data on compliance, training, risks, and more
Provide leadership with invaluable insight to fuel improvement and growth
Export dashboards to PDF for easy sharing
Export data from visualizations to CSV and XLSX formats

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ZenSign

Make compliance your signature move. Have your external partners sign without DocuSign or Adobe Sign

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

Learn more

Manage external party signature without DocuSign or AdobeSign

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 hourly call fees.

Your voice and experience matter 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 to pay for growth. We believe that an eQMS should be able to grow with you and quality shouldn't be silo'd, so we don’t charge for seat licenses. Let's grow together.