Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
AWS GovCloud
No
Agent Payments Protocol (AP2)
No
Cevinio
No
LivePreso
No
MishiPay
No
OpenText Core Share
No
Oracle Audience Segmentation
No
Oracle Digital Assistant
No
Oracle Subscription Management
No
Oracle Unity Customer Data Platform
No
Integrations
AWS GovCloud
Yes
Agent Payments Protocol (AP2)
Yes
Cevinio
Yes
LivePreso
Yes
MishiPay
Yes
OpenText Core Share
Yes
Oracle Audience Segmentation
Yes
Oracle Digital Assistant
Yes
Oracle Subscription Management
Yes
Oracle Unity Customer Data Platform
Yes
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
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
No
Artificial Intelligence (AI)
No
Audit Management
No
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
No
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
No
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
No
Workflow / Process Automation
No