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ZenQMS for Biotech/Biopharma Companies

“Our paper-based QMS keeps letting us down.”

We hear you. Outdated systems make day-to-day tasks complicated and time-consuming. That’s why we’re here. ZenQMS was purpose-built to help biotech/biopharma companies just like yours, so you can remain organized, audit-ready, and prepared for the next phase of operations.

Biopharma
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Vizuri saved thousands in storage and support fees by switching to ZenQMS. 
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IronShore Pharma chose ZenQMS to prepare for commercialization.

Access all modules from Day 1, including those critical to Biotech/Biopharma Companies

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 (Excel, CAD, Visio etc.)
  • Link related documents such as SOPs and forms
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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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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 27001:2022 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.