The zenqms platform

One Single System.
Every Single Regulated Process.

ZenQMS is the eQMS platform for life sciences. Your system of record to centralize documents, training, data, quality events, audits and other regulated activities into a single command center that reflects your actual organizational logic. Every module is audit-ready from day one, giving you the flexibility to go live without the normal implementation process drag.

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Product Capabilities

Everything You Need.
Available From Day One.

Data & Insights

Turn reporting time into quality time.

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Documents

Defensible version control, without the complexity.

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eSignatures

Compliant internal & external eSignatures built in your system of record.

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Folders & Filings

A living catalog of your quality data.

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Integrations

Connect the tools behind your critical quality operations.

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Quality Marketplace

Start with a pre-built foundation, then make it yours.

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Training

Compliant, current, and inspection-ready.

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Workflows

Shockingly easy to manage CAPAs, deviations, events, complaints, and more.

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ZenAI

AI embedded in your workflows. Auditable by design and traceable at every step.

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More Capabilities
ZenAI

AI You Can Show An Inspector

In regulated industries, AI is only useful if it’s defensible. ZenAI is purpose-built for GxP context — it understands SOPs, deviations, CAPAs, and change controls — and it lives inside the workflows where quality decisions already happen, not in a separate tool your team has to remember to open.

ZenAI Assistant
AI-Powered Search
Document Q&A
Document Summary
Training Question Generator
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ZenAI Assistant
Quality-specific agents embedded where the work happens.
Document Q&A
Ask questions against any controlled document and get sourced, traceable answers.
Document Summary
Generate an executive summary with key points in a click.
Training Question Generator
Comprehension-testing questions and validated answer choices built from your own procedures.
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Customer Success

Quality Teams Choose Zen

BIOQUAL: How a Fast-Growing CRO Eliminated Paper, Strengthened GLP Compliance, and Saved Months of Administrative Time with ZenQMS

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From Paper to eQMS: How MURR Modernized Its Growing GMP Quality Operation with ZenQMS

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From Warning Letter to Controlling Quality: How Bell International Laboratories Strengthened Its Quality System with ZenQMS

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Frequently Asked Questions

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What modules are included in ZenQMS?

Documents, Training, Workflows (change controls, CAPAs, deviations, events, etc.), Audits, Folders & Filings, Data & Insights, eSignatures, and Integrations.

Which compliance standards does ZenQMS meet?

SOC 2, ISO 27001, ISO 9001, GDPR, HIPAA, and 21 CFR Part 11 / Annex 11.

How does ZenQMS structure pricing?

ZenQMS pricing is designed with a runway for growth. We don't charge per seat license. Instead, the transparent pricing model includes a range of user licenses, allowing you to add users as your team grows without paying for every individual seat.

How does ZenQMS compare to other eQMS platforms like MasterControl?

ZenQMS is designed to be a robust eQMS that is more flexible, easier-to-use, faster to implement, and more scalable to your needs. In fact, customers such as PharmaLex migrated from MasterControl to ZenQMS in ~100 days for a better process fit.

Get Used To Things Going Well.

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