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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
Our platform is designed to guarantee that all employees adhere to the Standard Operating Procedures (SOPs) and relevant internal documents associated with their roles. With SOPTracker, it becomes effortless to assign SOPs and other important documents to any team member within your organization. Compliance among employees can be monitored with just a few clicks, all while maintaining the confidentiality and security of your company's sensitive information. Finally, there's a simple and cost-effective solution for tracking employee compliance. SOPTracker efficiently generates reports on employee adherence, safeguarding your proprietary information at the same time. By using SOPTracker, you can relax and let the platform streamline your compliance management process. In the modern workplace, where individuals often juggle diverse roles and responsibilities across various projects, maintaining compliance with SOPs can seem overwhelming; however, SOPTracker effectively addresses this challenge and simplifies the entire process.
API Access
Has API
API Access
Has API
Integrations
Microsoft Azure
Microsoft Entra ID
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$1000 per year
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
Information Management Services (IMS)
Founded
1973
Country
United States
Website
www.soptracker.com/about/