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ZenQMS for Contract Research Organizations

“Managing training and documents on spreadsheets and paper is a nightmare!”

We hear you. With a paper-based QMS, even the most basic operations can get complicated. That’s why ZenQMS was purpose-built with CROs in mind. Our configurable quality tools keep everything organized, even as processes get more complex and your company grows.

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Baim Institute eliminated unnecessary legacy systems by switching to ZenQMS.
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Peachtree BioResearch Solutions pivoted to 100% virtual audits.

Access ALL modules from Day 1, including those critical to Clinical Research Organizations

TRAINING MODULE

Gain full visibility into your company’s training status in real-time

  • Support training for study teams or site-specific requirements
  • Receive daily email notifications of past-due signatures and actions
  • Create, track, and complete training from SOP reviews to on-the-job events
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ISSUES MODULE

Control your quality events in an audit-ready system

  • Manage CAPAs, deviations, and your quality control process with just a few clicks
  • Track all ongoing processes while maintaining complete data integrity 
  • Design multi-stage workflows, including root cause analysis and effectiveness checks
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DOCUMENTS MODULE

Track every draft throughout your entire document lifecycle

  • Stay 21 CFR Part 11/ Annex 11 compliant for all electronic signatures
  • Automate and enforce workflow approval processes for each type of document
  • Maintain a system of record for files of any type and size (both internal and study-specific)
  • Link related documents such as SOPs and forms
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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. No seat licenses required. 
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 27001:2022 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.