Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Carizma QM is an online application designed to assist users in overseeing the complete lifecycle of regulated documents, encompassing stages from drafting and reviewing to approving, releasing, and archiving. It enables the creation and management of essential documents, such as Standard Operating Procedures (SOPs), through integrated workflows that facilitate the review and approval process. Upon approval, the system automatically initiates a training workflow where users must acknowledge they have read and understood the document. The software incorporates an electronic signature feature that complies with 21 CFR Part 11 regulations, ensuring a display of users who have acknowledged their understanding of the documents. Additionally, it maintains a validated audit trail, enhancing users' ability to manage regulated documents directly within Carizma QM. Authors can specify crucial information, including the document type (such as SOP, work instruction, form, or checklist), the document title, the process owner (the relevant department), and the user groups to which the document applies, along with setting a review cycle. Users are notified via email in a timely manner when a document requires their review, and Carizma QM generates the initial document framework to streamline this process. Overall, the software simplifies and enhances the management of regulated documentation through its comprehensive features.
Description
ZenQMS is an electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO organizations. 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
Corrective and Preventive Actions
Deviations, non-conformances, complaints, issues, and other quality events
Change controls
Audit management
Critical quality workflows
Supplier and vendor management
Electronic signatures with 21 CFR Part 11-compliance
Risk management
Quality metrics tracking and reporting
API Access
Has API
No
API Access
Has API
No
Integrations
Adobe Acrobat
Yes
Microsoft Azure
No
Microsoft Word
Yes
Okta
No
Res_Q
No
Integrations
Adobe Acrobat
No
Microsoft Azure
Yes
Microsoft Word
No
Okta
Yes
Res_Q
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
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 Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Axicos
Founded
2007
Country
Switzerland
Website
www.axicos.com/software-solutions
Vendor Details
Company Name
ZenQMS
Founded
2010
Country
United States
Website
www.zenqms.com
Product Features
Legal Document Management
Access Controls
No
Archiving & Retention
No
Collaboration
No
Contract Management
No
Document Assembly
No
Document Indexing
No
Document Tagging
No
Full Text Search
No
Version Control
No
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes