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Average Ratings 0 Ratings

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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

The Compliance Suite platform is a versatile and innovative technology solution designed to facilitate the preparation and submission of various regulatory forms, including the Securities and Exchange Commission’s Form N-PORT, Form N-CEN, Form N-MFP, and Form PF, along with other filing obligations such as Annex IV of AIFMD and CFTC, and NFA Form CPO-PQR. Additionally, it offers comprehensive tools for risk management, performance monitoring, and managing pipeline and relationships within the asset management sector. This user-friendly and scalable solution delivers the adaptability needed to navigate today’s fast-paced business, risk, and regulatory environments. The architecture of Compliance Suite allows for customization, enabling the system to be utilized for purposes beyond just regulatory filings. Furthermore, it serves as a data repository for internal risk assessment and investor reporting, while also featuring a customizable dashboard and fund performance charting capabilities to enhance user experience. Ultimately, this platform empowers asset managers to streamline compliance processes and improve operational efficiency.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

AWS GovCloud
Agent Payments Protocol (AP2)
Appway Digital Banking
Exponential AI Enso
LivePreso
OpenText Core Share
Oracle Audience Segmentation
Oracle Digital Assistant
Oracle Partner Relationship Management
Oracle Unity Customer Data Platform
Orbiit
PlainID
REACH
RedShield
ServiceNow IT Operations Management
ServiceNow Integrated Risk Management
ThetaRay
TransferMate
Verbio

Integrations

AWS GovCloud
Agent Payments Protocol (AP2)
Appway Digital Banking
Exponential AI Enso
LivePreso
OpenText Core Share
Oracle Audience Segmentation
Oracle Digital Assistant
Oracle Partner Relationship Management
Oracle Unity Customer Data Platform
Orbiit
PlainID
REACH
RedShield
ServiceNow IT Operations Management
ServiceNow Integrated Risk Management
ThetaRay
TransferMate
Verbio

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

Deloitte

Founded

1845

Country

United Kingdom

Website

www2.deloitte.com/content/dam/Deloitte/us/Documents/risk/us-risk-financial-technology-compliance-suite.pdf

Product Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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