ZenQMS GxP Compliance

ZenQMS GxP Compliance

Quality Management & GxP compliance for the rest of us

The ZenQMS cloud-native Quality Management System is designed to help GxP companies achieve and maintain compliance while simultaneously streamlining critical-to-quality processes. From training to document management, deviations/CAPAs, change controls, and audits, ZenQMS helps customers maintain a state of control from anywhere. No need to tailor your processes to the software; ZenQMS configures around your processes. 

ZenQMS supports the life sciences community with a unique, disruptive approach to quality management organized around a platform that is easy to acquire, implement, validate, and use. The company supports hundreds of businesses across the GxP spectrum, including innovators and GxP vendors/contractors around the world, and has seen firsthand how difficult this transition to qualified cloud services can be for teams with less validation and cloud services experience. With a guaranteed uptime of over 99.99% and a conservative approach to documenting and meeting the relevant FDA (GxP / ISO 9001), security (ISO 27001 / SOC 2/Type II), and Privacy (HIPAA, GDPR, EU-US Privacy Shield) regulations, ZenQMS is a quality solution that helps its customers meet stringent quality regulations out of the box. 

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. 

You can download our Vendor Assurance Report that details the results of our rigorous assessment by filling our the form on this page.

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

Scott Harris, TriRxAPI and Drug Manufacturing | Read the case study
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“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.”
Kelly Thomas, Veru PharmaBiopharmaceuticals | Read the case study
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“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.”
Adaora Chukwu, EO ProductsConsumer Products | Read the case study
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“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.”
Joel Stephens, PeachTree BioResearch Solutions Biopharma CRO | Read the case study
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“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.”
Judy Zahora, Agenus Biopharmaceutical | Read the case study
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“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.”