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Average Ratings 0 Ratings

Total
ease
features
design
support

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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

Numerous organizations face significant challenges in optimizing their information supply chains. One prevalent issue involves the automatic generation of intricate documents that incorporate structured data sourced from databases or applications. Due to the vast amount of complex information and varying regulations across jurisdictions, employees often dedicate excessive time to document creation. This labor-intensive and repetitive process not only leads to an increased likelihood of errors in the documents produced but also incurs unnecessary costs for the workforce. For entities such as insurers, legal professionals, and healthcare providers who must navigate a myriad of laws and regulations, the task of producing complex documents becomes both costly and time-consuming. Consequently, the ability to automatically generate documents that comply with all relevant legal requirements poses a substantial challenge for many organizations. Addressing this issue is critical for enhancing efficiency and reducing operational expenses.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$57 per user per month
Free Trial Yes 
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 Yes 
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 No 
Live Training (Online) No 
In Person Yes 

Vendor Details

Company Name

Agatha

Founded

2015

Country

United States

Website

en.agathalife.com

Vendor Details

Company Name

Invantive

Founded

2001

Country

Netherlands

Website

www.invantive.com

Product Features

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery Yes 
Document Indexing No 
Document Retention Yes 
Electronic Signature No 
Email Management No 
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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