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What is ZenQMS?

ZenQMS is an electronic Quality Management System (eQMS) built for GxP-regulated life sciences organizations, including Biopharma, CROs, and CMO/CDMO companies. The cloud-based, AI-enabled, fully validated platform is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs Deviations, non-conformances, complaints, issues, etc Change controls Audit management Critical quality workflows Supplier & vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting

What is Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

Media

Media

No images available

Integrations Supported

Microsoft Azure
Okta
Res_Q

Integrations Supported

API Availability

API Availability

Pricing Information

ZenQMS does not charge per seat license, allowing you to grow without sacrificing compliance. Our pricing is simple and transparent, and is based on the complexity of the account and initial migration/configuration activity. Contact ZenQMS today for more details.

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

ZenQMS

Date Founded

2010

Company Location

United States

Company Website

www.zenqms.com

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Categories and Features

Life Sciences

Not specified

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

Life Sciences

Not specified

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