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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
API Access
Has API
Integrations
Jira
Tricentis Tosca
qTest
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
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
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation