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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
Validfor is a robust and secure digital validation platform that consolidates the entire validation process into a single, paperless system, specifically tailored for industries that are heavily regulated. This platform not only streamlines validation tasks but also guarantees adherence to critical standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11.
With capabilities for handling electronic records and advanced electronic signatures, Validfor ensures complete audit trails, role-specific workflows (including Author, Reviewer, and Approver), and thorough CSV compliance. It securely organizes all documentation and records within a centralized repository, meticulously tracking every modification to maintain data integrity and uphold Quality Assurance.
Additionally, Validfor provides integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, thereby facilitating smooth impact assessments, tracking of CAPA, Computer Software Assurance (CSA), and management of audit-ready lifecycles. This comprehensive approach not only enhances operational efficiency but also strengthens compliance across various validation activities.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
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
Validfor
Founded
2024
Country
Estonia
Website
validfor.com