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Average Ratings 0 Ratings
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
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
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
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
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