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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 Carizma QM?

Carizma QM is a web-based tool crafted to help users manage the entire lifecycle of regulated documents, from the initial drafting and review phases all the way through to approval, release, and eventual archiving. It allows for the creation and oversight of crucial documents like Standard Operating Procedures (SOPs) via integrated workflows that promote efficient review and approval. Once a document receives approval, the system automatically triggers a training workflow, requiring users to confirm that they have read and comprehended the document. The application includes an electronic signature capability that adheres to 21 CFR Part 11 regulations, ensuring a record of users who have acknowledged their understanding of the documents. Furthermore, it provides a validated audit trail, which significantly aids users in managing regulated documents directly within Carizma QM. Authors have the ability to define important details such as the document type (including SOP, work instruction, form, or checklist), the title of the document, the process owner (designated department), and the applicable user groups, while also establishing a review cycle. Timely notifications are sent to users via email when their review of a document is necessary, and Carizma QM facilitates the creation of an initial document framework to make this process more efficient. By offering these extensive features, the software not only streamlines but also enhances the management of regulated documentation, ensuring compliance and efficiency throughout the entire process. Ultimately, Carizma QM serves as an indispensable resource for organizations seeking to maintain rigorous standards in their document management practices.

Media

Media

Integrations Supported

Adobe Acrobat
Microsoft Azure
Microsoft Word
Okta
Res_Q

Integrations Supported

Adobe Acrobat
Microsoft Azure
Microsoft Word
Okta
Res_Q

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

ZenQMS

Date Founded

2010

Company Location

United States

Company Website

www.zenqms.com

Company Facts

Organization Name

Axicos

Date Founded

2007

Company Location

Switzerland

Company Website

www.axicos.com/software-solutions

Categories and Features

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

Legal Document Management

Access Controls
Archiving & Retention
Collaboration
Contract Management
Document Assembly
Document Indexing
Document Tagging
Full Text Search
Version Control

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