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ease
features
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support

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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

GoVal is an AI-powered validation software purpose-built to digitize the full validation lifecycle across pharma, biotech, medical device, and other life science industries. From Computer System Validation (CSV), Equipment Qualification, and various validation requirements to broader GxP compliance needs, it leverages intelligent automation to deliver streamlined digital workflows—all within a secure, paperless framework. Its customizable platform with role-based workflows enables automated reviews, approvals, and real-time visibility, backed by compliant e-signatures and audit-ready traceability. Built to meet 21 CFR Part 11, EU Annex 11, and leading GxP standards, GoVal ensures seamless regulatory alignment. Risk-based strategies at the URS level empower teams to drive targeted mitigation planning and precise test case design. GoVal AI goes further—accelerating validation timelines through generative assistance for risk assessments, documentation, and test development. An in-built Document Management System (DMS) allows users to securely store, organize, and retrieve validation documents as needed—supporting data integrity, traceability, and effortless access during audits. Integrated deviation management, change tracking, and continuously updated data simplify inspections while reducing manual errors. The result: faster deployment, lower compliance costs, and stronger ROI—delivered with clarity, control, and continuous compliance.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

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

AdventSys Technologies

Founded

2015

Country

India

Website

www.govalidation.com

Product Features

Scientific Data Management System (SDMS)

Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows

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