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
Montrium is a knowledge-based business that uses its deep understanding of GxP technologies and processes to provide cost-effective solutions for life science organizations.
Montrium Connect, the industry-leading platform for managing regulatory content, processes, and compliance in life sciences, has been designed to meet the needs of the new pharmaceutical business model. Users can collaborate and find the information they need faster and easier with intuitive navigation, enhanced user experience and dynamic content management.
API Access
Has API
No
API Access
Has API
No
Integrations
Quality Connect
No
RegDocs Connect
No
eTMF Connect
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
Yes
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
Yes
Vendor Details
Company Name
Agatha
Founded
2015
Country
United States
Website
en.agathalife.com
Vendor Details
Company Name
Montrium
Founded
2005
Country
Canada
Website
www.montrium.com
Product Features
Product Features
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
No
Document Capture
No
Document Conversion
Yes
Document Delivery
No
Document Indexing
Yes
Document Retention
Yes
Electronic Signature
Yes
Email Management
Yes
File Recovery
Yes
File Type Conversion
Yes
Forms Management
Yes
Full Text Search
No
Offline Access
Yes
Optical Character Recognition
Yes
Print Management
No
Version Control
Yes