ZenQMS for Contract Development and Manufacturing Organizations

ZenQMS for CMOs and CDMOs

“Our paper-based QMS just can't keep up.”

We hear you. Trying to stay audit-ready with paper and shared files is overwhelming. That’s why we built ZenQMS to help CMOs and CDMOs just like yours. Our configurable quality tools will save you time and resources, especially as your business starts to scale.

Schedule a Demo

See why TriRx implements ZenQMS in its GMP manufacturing sites

Read the Case Study

Avara has eliminated 100% of their lost documents with ZenQMS.

Read the Case Study

Access all modules from Day 1, including those critical to CMOs + CDMOs

View your entire risk management process for end-to-end traceability using the Issues Module in ZenQMS

ISSUES MODULE

Control your quality events in an automated and audit-ready system

Handle CAPAs, deviations, and complaints with just a few clicks
Configure forms and processes to match your current processes
Design multi-stage workflows, including root cause analysis and effectiveness checks
Access reporting for all data for easy risk and trend analysis

CHANGE CONTROL MODULE

Keep an accurate record of change within your organization

Manage document change requests, ECOs, and electronic batch records with ease
Track all ongoing processes while maintaining complete data integrity
Reduce audit times with a straightforward interface that regulators understand
Automate issue notifications and investigator assignments

Create and automate workflows to match your current processes using the Documents Module in ZenQMS

DOCUMENTS MODULE

Create and automate workflows to match your current processes

Store executed batch records, labels, and work instructions without confusion
Remain 21 CFR Part 11/ Annex 11 compliant for all electronic signatures
Link imported files of any size (Word, Excel, CAD, etc.) across all modules

Learn About Our Full Suite of Connected Modules

The ZenQMS Difference

ZenQMS was built on the belief that, regardless of size, every Life Sciences organization should have access to the advantages that come with an electronic quality management system.

Easy-to-use

Rather than force you into pre-designed templates, ZenQMS modules are fully configurable to match your current forms and processes. Familiarity makes things move a lot faster!

Easy-to-Implement

Instead of an arduous 12-month process, we aim to have all clients up and running in 90 days, and often in less time than that. We want you to earn ROI as soon as possible!

Simple, Transparent Pricing

From Day 1, you’ll receive access to every module for everyone on your team. We don’t believe in seat licenses, a la carte upselling, or long-term contracts. Do you?

Lifetime Support

You deserve the best help. That's why our customer success team is completely in-house, there's no hourly charge for support, and our response time is measured in minutes.

Peace of Mind

Our system is turn-key and fully managed/supported by ZenQMS-- meaning minimal IT resource needs to maintain it. The cloud-based, closed-loop system ensures data integrity, with guaranteed uptime of >99.99%.

Validation-ready

The ZenQMS platform is fully validated for GxP per GAMP 5 guidelines for a Category 4 system. We are also ISO 9001:2015 and ISO 27001: 2013 certified, and HIPAA compliant.

Empathy

We built our platform to identify and address the very same problems and frustrations we encountered as Quality Leaders ourselves. We know what you’re going through.

A Complete System

Right from the start, you have access to all of our connected modules: Documents, Training, Issues, Change Control, and Audits. Implement them at your own pace.