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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
Innovatum provides a thorough labeling and regulatory-data management solution tailored for companies in the life sciences sector, such as those involved in pharmaceuticals, medical devices, and biotechnology manufacturing. Central to their offering is the ROBAR platform, which acts as an enterprise-level label management system facilitating every phase of the label lifecycle, from master-data management (PIMS/MDM) and artwork/version control (with native capabilities for managing Adobe files) to regulatory-data submissions (including UDI/MDR/IVDR/Eudamed and GS1 data pool) and culminating in final label printing, print-inspection integration, and compliant archiving. The platform is designed to be configurable, allowing for enhancements to be added to the core product without necessitating rework during upgrades, and it can be deployed through on-premises, hosted, or single-tenant cloud/SaaS configurations, accommodating various IT infrastructure preferences. Additionally, Innovatum features an eLabeling (eIFU) module that connects products, their versions, and translations to electronic instructions for use, enhancing user accessibility and compliance. This comprehensive system not only streamlines processes but also ensures regulatory adherence for its users.
API Access
Has API
API Access
Has API
Integrations
Adobe Creative Cloud
HL7 FHIR
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
Innovatum
Founded
1993
Country
United States
Website
www.innovatum.com