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The Less Stress QMS Software for Contract Research Organizations

When research reliability – and your reputation – are on the line, you need clinical trial quality management software that can keep up.

With ZenQMS, you can: 

  • Automate time-consuming tasks like training assignments and review reminders
  • Add all staff and contractors to the system (we don’t charge by seat license!)
  • Pull quality data and training reports in seconds, then export to PDF for easy sharing with stakeholders
  • Get specific about who sees what clinical trial data with granular user permissions
  • Stay cGCP compliant and audit-ready across multiple sites with robust training, version control tools, and more
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Why is ZenQMS the best QMS Software for CROs?

 Improve clinical trial compliance without complexity.

A Focus on Flexibility

ZenQMS is configurable, which means you can adapt the system’s workflows (think CAPAs, training assignments, deviations, etc.) to meet your processes – and each of your sponsors' different requirements.

Built for Multi-Site Teams

Globally dispersed teams make it difficult to ensure all staff is prepped on protocols. With strict version controls, 21 CFR Part 11 e-signature compliance, and intuitive document search, it’s easy to find the right materials, right now, right where you are.

Audit-Ready Always

Put sponsors at ease with real-time reporting by individual, training course, or role. Link issues and deviations to CAPAs for automatic closed-loop traceability. You don’t have to get audit-ready if you stay audit-ready.

Validation Made Simple

Forget the validation stress. Get free access to our validation materials as our support team guides you through the process from start to finish.

A closer look at the ZenQMS quality management modules

An eQMS with the quality management features critical to cGCP-regulated contract research organizations.

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

 

How CROs use ZenQMS to control quality

“We knew we had to find something and ZenQMS was far more affordable than every other enterprise system we looked at. But what really sold me was that we didn’t have to pay per user.”
Catherine AlbertOnda
“Being audit-ready at all times is a critical component of our business. ZenQMS has facilitated that for us in a way that exceeded my expectations.”
Phillip StricklandTranslational Drug Development (TD2)
“It's a one-stop shop, and that’s been the theme of why we love ZenQMS so much. It has really allowed us to not be in reactive mode but rather a proactive mode.”
Kristyn SamaClarivate
“Once the heads of our departments saw ZenQMS and how easy it was going to be for their employees to use, there was no doubt this was exactly what we needed.”
Nicholas KalogerasVanguard Clinical