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About

Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.

About

ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS 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 (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners

Audience

Life Sciences organizations, such as Biotech, Pharma, CRO, CMO/CDMO, Logistics, Labs, and more

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

No images available

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

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.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Qualitum
qualitum.ai

Company Information

ZenQMS
Founded: 2010
United States
www.zenqms.com

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Merit for Life Science

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Veeva Vault

Veeva Vault

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Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

Categories

Quality Management Features

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

Integrations

Microsoft Azure Not Supported
Okta Not Supported
Res_Q Not Supported

Integrations

Microsoft Azure Supported
Okta Supported
Res_Q Supported
Claim Qualitum and update features and information
Claim Qualitum and update features and information
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Claim ZenQMS and update features and information