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
Tricentis Vera redefines Digital Validation by going beyond merely affixing electronic signatures to digital documents, instead revolutionizing the Computer Systems Validation process to eliminate cumbersome and unnecessary documentation practices while ensuring compliance is inherently linked to robust software quality measures. By integrating triggers and controls for capturing electronic signatures that comply with 21 CFR Part 11 into Agile software testing workflows, organizations can significantly hasten their time to market with Tricentis Vera. Additionally, Vera offers a unified interface across various tools, serving as a comprehensive system of record that allows users and teams to monitor their review and approval processes in real-time. After validation assets are either submitted for approval or receive the necessary endorsements, the records are securely locked in both qTest and Jira, preventing any alterations during or after the approval phase. This seamless integration ultimately enhances collaboration and streamlines workflows, ensuring that quality and compliance are maintained throughout the software development lifecycle.
API Access
Has API
No
API Access
Has API
No
Integrations
Adobe Acrobat
Yes
Jira
No
Microsoft Word
Yes
Tricentis Tosca
No
qTest
No
Integrations
Adobe Acrobat
No
Jira
Yes
Microsoft Word
No
Tricentis Tosca
Yes
qTest
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
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
No
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
No
Vendor Details
Company Name
Axicos
Founded
2007
Country
Switzerland
Website
www.axicos.com/software-solutions
Vendor Details
Company Name
Tricentis
Founded
2007
Country
United States
Website
www.tricentis.com/products/digital-validation-vera/
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
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
No
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
No
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
No
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
No
Workflow / Process Automation
No