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
Safeguard your enterprise and adhere to country-specific drug serialization mandates and rapidly evolving regulations while effectively managing vast data quantities with smart solutions. Utilize the SAP Advanced Track and Trace for Pharmaceuticals application to ensure compliance with both international and local laws, as it features a comprehensive serialization repository, efficient serial number management, and robust regulatory reporting functions. Lower the costs associated with compliance for both current and future serialization obligations, including specific reporting requirements for various nations. Enhance your supply chain's productivity by gaining deeper insights into the movement of materials, all the way down to the sales-unit-item level. Efficiently manage extensive serialization data while staying agile enough to embrace new legislative changes. Maintain oversight of retail product serial numbers within a centralized corporate repository, ensuring that you meet all country-specific regulations when it comes to reporting these serial numbers. By implementing these strategies, your business can not only streamline operations but also stay ahead in a competitive market.
API Access
Has API
No
API Access
Has API
No
Integrations
APSentra
No
Nextbitt
No
SAP Joule
No
Streams.AI by PanTerra Networks
No
TrueCommerce
No
Integrations
APSentra
Yes
Nextbitt
Yes
SAP Joule
Yes
Streams.AI by PanTerra Networks
Yes
TrueCommerce
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
SAP
Founded
1972
Country
Germany
Website
www.sap.com/products/track-trace-pharmaceuticals.html