Partnership

ZenQMS GxP Compliance

Quality Management and GxP compliance with less stress, less complexity, and more support.

ZenQMS is an eQMS platform that empowers Quality teams to control quality and keep their companies compliant from anywhere with less stress, less complexity, and more support. From early stage to enterprise, over 100,000+ users trust ZenQMS.

Built by Quality leaders who believe Quality teams deserve better, simpler tools, these are just a few things that make us different:

No seat licenses. We don’t charge by seat licenses, meaning pricing never holds your growth back. All members of your team can have access from day one.
Effortlessly configurable. ZenQMS adapts to match your specific processes, workflows, and quality needs. With our system, you get exactly what you need, when you need it, the way you’re used to seeing it.
Implementation at your speed. Need to get started ASAP? We can do that. You set the pace of implementation and our team moves to match it so quality never misses a beat.
Validation made simple. Validation is required… validation headaches are not. We don’t charge for access to our validation materials and our support team guides you through the process from start to finish.
Easy to use. No need to retrain employees on how to use the system every time they sign in. Our dashboard allows everyone to see their compliance status at a glance, quickly find the docs and training they need, and easily complete assigned tasks — without needing an IT degree.
Compliance without compromise. We’re SOC II, ISO 27001, ISO 9001, GDPR, 21 CFR Part 11/ Annex 11, and HIPAA compliant. Because we take security & compliance as seriously as you do.

ZenQMS is Cloud Assurance Certified

ZenQMS is among a select group of technology providers committed to serving and advancing the life science industry. As a Cloud Assurance Certified technology, users can trust that ZenQMS is an excellent choice to achieve and maintain regulatory compliance globally. As part of this certification USDM publishes our Vendor Assurance Report to establish ZenQMS’ credibility and compliance maturity.

Fill out the form on the right to download our Vendor Assurance Report that details the results of USDM’s rigorous assessment.

Download USDM's Vendor Assurance Report for ZenQMS

USDM Cloud Assurance for ZenQMS

Offered with ZenQMS, USDM Cloud Assurance includes an annual vendor audit you can leverage, an accelerated initial validation, and a USDM automated testing tool (ATT) that replaces the manual operational qualification (OQ) and provides ongoing regression testing of core requirements. Learn more about USDM’s proven Cloud Assurance program and methodology by downloading the below datasheet.

How ZenQMS + USDM can support your ZenQMS GxP Compliance

ZenQMS delivers a cloud-based eQMS platform purpose-built for life sciences organizations and designed for 21 CFR Part 11 / Annex 11 and relevant GxP/ ISO requirements from the ground up. The tool is easy to configure, validate and use, and it automates and enforces quality workflows matching your actual processes.

USDM helps stretched quality teams who are implementing or using a ZenQMS account to simplify even further:

Initial Audit/Qualification of ZenQMS: Provides your organization with a comprehensive annual vendor audit to save time and effort with your vendor requalification endeavors.
Maintain Continuous Cloud Compliance: Let USDM’s Cloud Assurance subscription keep your teams ready for any new releases ZenQMS deploys.
Build or Enhance your Quality Management Processes: Whether you need a gap assessment, some monthly recurring advice, or fully outsourced quality management/validation help, USDM is ready to help.

What ZenQMS Customers are Saying

“We’ve come to ZenQMS with some ridiculous challenges and timelines, and we wouldn’t have returned if the staff weren’t outstanding to work with,” adds Scott. “Every single time I’ve said, ‘Here’s our challenge, can you help us?’, they’ve absolutely jumped on board.”

“I love your pricing because it’s straight-forward; there’s one upfront cost. I don’t have to constantly go back to management and justify why I need more money. You’ve streamlined all of the pain points that I’ve had in previous implementations. Great job making it very simple.”

“ZenQMS’ user-friendliness and the ability to customize around our processes are what I responded to when doing my research,” said Adaora. “So when I saw the price, I thought it was quite reasonable and almost too good to be true. I’m getting so much more than I thought I would with ZenQMS.”

“One of the things that impressed us during our decision-making process was that ZenQMS's leadership team came from the quality world and designed the system around meeting compliance,” says Joel. “We felt confident because we knew that the folks who designed ZenQMS knew a lot about quality assurance.”

“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.”