Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Agatha provides a comprehensive range of cloud-based solutions specifically designed for the life sciences sector, facilitating the centralized oversight of documents and processes related to clinical operations, quality assurance, regulatory compliance, and training activities. This platform caters to the workflows of biotech firms, pharmaceutical companies, medical device manufacturers, and contract research organizations by offering various modules, including eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for creating and approving standard operating procedures (SOPs) as well as managing quality documents related to CAPAs, deviations, and change controls. Additionally, Agatha enhances regulatory document handling, ensuring smooth document creation, review, approval, storage, and sharing within a single cohesive system. By promoting a paperless approach, it alleviates administrative burdens and bolsters data security, while being constructed on a global-compliance framework that meets critical standards such as 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha empowers life sciences organizations to optimize their operations and maintain compliance with industry regulations more efficiently.
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
Jira
No
Tricentis Tosca
No
qTest
No
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
No
Live Rep (24/7)
Yes
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)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Agatha
Founded
2015
Country
United States
Website
en.agathalife.com
Vendor Details
Company Name
Tricentis
Founded
2007
Country
United States
Website
www.tricentis.com/products/digital-validation-vera/
Product Features
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