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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 Zelthy Platform?

The Zelthy Platform is a dynamic application framework tailored for organizations in the pharmaceutical and life sciences fields, empowering them to build, deploy, and oversee business applications along with AI-integrated workflows. Leveraging the open-source Zango framework, it provides an array of reusable templates, packages for workflows and CRUD operations, access controls tailored to specific roles, compliance with policy regulations, audit logging capabilities, support for multi-tenancy, and an environment for supervised AI agents. The platform’s preconfigured agent blueprints cater to a variety of tasks, such as patient enrollment, patient detection, adverse event monitoring, field visit validation, document handling, and compliance assurance. Development teams enjoy the freedom to augment the platform using Python and Django, all while retaining ownership of their application code, with deployment options spanning cloud, private cloud, on-premises, or hybrid configurations. Specifically designed for engineering and operations teams in the life sciences sector, it aims to facilitate application development that meets rigorous regulatory requirements. Moreover, the platform's extensive features not only streamline processes but also promote the integration of cutting-edge technologies into established workflows, enhancing overall operational efficiency. This versatility positions the Zelthy Platform as a pivotal tool for organizations striving for innovation and compliance in an increasingly complex industry landscape.

Media

Media

No images available

Integrations Supported

Microsoft Azure
Okta

Integrations Supported

Adobe Acrobat Sign
Amazon Web Services (AWS)
Docusign
Google Workspace
Microsoft 365
NiCE CXone Mpower
Oracle Fusion Cloud ERP
Snowflake
TraceLink
Twilio
Veeva CRM
Veeva Vault
Veeva Vault RIM
Zelthy Commercial Operations
Zelthy Compliance
Zelthy Patient Services
Zelthy Regulatory Affairs
Zelthy Traceability

API Availability

API Availability

Has API

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

Zelthy

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/platform

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

AI Agent Builders

Not specified

Life Sciences

Not specified

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