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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

Digital Blueprint serves as a comprehensive repository for the processes and Standard Operating Procedures that unify your workforce, partners, clients, and suppliers. In the absence of this clarity, information tends to be scattered across various documents, platforms, and personnel, leading to challenges in change management, delaying the incorporation of new processes and systems, and amplifying the likelihood of errors. This disorganization ultimately detracts from the experience for both users and the customers they aim to support. By meticulously documenting both manual tasks and system functions in a visually intuitive manner, businesses can enhance efficiency and minimize errors. Furthermore, the Ops Analyzer tool empowers businesses to assess the potential impacts of modifications in one operational component on others, fostering a more cohesive business environment. This interconnected approach not only streamlines processes but also enhances overall organizational agility.

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

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 No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Agatha

Founded

2015

Country

United States

Website

en.agathalife.com

Vendor Details

Company Name

GIEOM

Founded

2012

Country

India

Website

www.gieom.com/digital-blueprint/

Product Features

Policy Management

Approval Process Control No 
Attestation No 
Audit Trails No 
Policy Creation No 
Policy Library No 
Policy Metadata Management No 
Policy Training No 
Reporting / Analytics No 
Version Control No 
Workflow Management No 

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