Why risk product quality, client trust, or promised delivery dates? Get cGMP-compliant quality management software that won’t slow down production — or force you to overhaul your proven quality processes.

With ZenQMS, you can:

Keep production on track by automating approval workflows, reminders, and escalations
Configure workflows to match the needs of each site – no IT support required
Link deviations to CAPAs for easy access and full traceability
Impress clients and auditors with real-time reports, automatic audit trails, and easy-to-read dashboards
Ditch the seat license pricing model and scale your teams without breaking the budget

Why is ZenQMS the best QMS Software for Manufacturing Organizations?

Quality control software for manufacturing that just works.

Cut Down on Downtime

ZenQMS keeps production downtime to a minimum by making it easy to track deviations, document CAPAs, and get signatures. And when you need urgent quality support to get things back on track, our team is there with a Help Desk response time that averages less than 25 minutes.

Reduce Audit Anxiety

For manufacturers, audits are high-stakes, but they don’t have to be high-stress. ZenQMS makes audits easier by keeping you constantly ready with automatic audit-trails, strict version controls, and regulator-friendly document storage, meaning your Quality team can actually sleep the night before an audit.

Built for Multi-Site Teams

With ZenQMS, there’s no need to wonder which documents are in circulation at which site. With strict version controls, 21 CFR Part 11 e-signature compliance, and intuitive document search, it’s easy for your team to find the right materials, right now, wherever they are.

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.

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

“From my point of view, the most important thing is that ZenQMS is CFR compliant, ISO 9001, and 27001 certified, and maintains these systems with vigorous, robust validation and verification practices.”

Allie FocoAutumn Harp, Quality Systems Manager

“ZenQMS is easier to use, easier to learn, and we’re not paying for a bunch of features we don’t need.”

Michelle MerwinDirector of Quality Assurance, Formlogic

“I believe that within 30 days, after things are ironed out and everything is validated, there’s not a single site or person who regrets using ZenQMS. I’ve recommended them to a number of companies as well because of how impressed I am with them.”

Scott HarrisVice President of Information Systems, TriRx

“Without a scalable system like ZenQMS, we would need to hire another FTE on the Quality team to support current needs. If we had continued with a manual, paper-based system, we would likely have incurred $30K annually in storage and archiving costs.”

Tracy FullerSenior Quality Assurance Director, Vizuri Health Sciences

The Less Stress QMS Software for Contract Manufacturing Organizations