We hear you. Meeting regulatory requirements with an outdated system can be overwhelming. That’s why we’re here. ZenQMS was built to help medical device companies like yours stay organized, compliant, and audit-ready, so you can check the boxes and move on with your day.
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.
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!
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!
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?
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.
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%.
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.
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.
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.