Skip to content
Close
SEARCH
CONTACT
E-MAIL: hello@zenqms.com
Book a Demo
Login
E-MAIL: hello@zenqms.com
Book a Demo
Login

The Less Stress QMS Software for Pharma and Biotech Organizations

Whether your organization is in early development for the latest treatments or in full commercialization mode, you need compliance without complexity. 

With ZenQMS you can:

  • Automate time-consuming tasks like training assignments and review reminders
  • Adapt your workflows as your organization scales without the need for IT support
  • Budget accurately with a predictable pricing model (i.e. no seat licenses)
  • Focus on the next therapeutic milestone, not managing a complicated eQMS
Zoomed_In_New_Dashboard (1)

Why is ZenQMS the best QMS Software for Pharma and Biotech?

An unshakeable foundation of quality that grows with you.

The Right Fit, Right Now

With ZenQMS, you get a configurable system that flexes to fit your needs no matter where you are on the clinical to commercial journey.

Relief with Automated Quality Management

ZenQMS automates the quality management tasks that used to mean hours of chasing down employees, so you can do more while stressing less.

Compliance Without Compromise

ZenQMS meets the highest risk mitigation, safety and regulatory standards including SOC II, ISO 27001, ISO 9001, GDPR, 21 CFR Part 11/ Annex 11, and HIPAA compliance.

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 pharmaceutical and biotech 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 biopharma companies use ZenQMS to control quality

“One of the nice things about Zen is the ability to configure those workflows for change control and issues. Angels sang when I saw that I could do that, because that was probably the number one complaint in other companies and software.”
Tiffany StreettMapLight Therapeutics
“I love that in less than 30 seconds, I can see my entire company’s training status and download it onto a spreadsheet. Before, it would've been three reports, pulled from a bunch of different places, and it would’ve taken days. It shouldn’t be hard, but it was before ZenQMS.”
Judy ZahoraAgenus
“The biggest advantage is the time-frame from launch. A competitor I’ve worked with takes a lot longer to get everything built the way you want it before you can actually start the implementation. ZenQMS is the fastest system to put into place.”
Jackie AmadorAmador Clinical Research Consulting
“Nordic Pharma’s quality of documentation control process with ZenQMS was appreciated by the FDA inspector as expressed during our Management closeout.”
Marie MyersNordic Pharma