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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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 

Screenshots View All

Screenshots View All

Integrations

Quality Connect No 
RegDocs Connect No 
eTMF Connect No 

Integrations

Quality Connect Yes 
RegDocs Connect Yes 
eTMF Connect 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 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

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 

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