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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
From the viewpoint of managing cell production, organizations aim to oversee every aspect of the production process, including the collection of samples, procurement of raw and auxiliary materials, utilization of instruments and equipment, staffing, environmental conditions, and procedural elements, to optimize resource efficiency. This approach ensures that resources are neither in excess nor deficient, while also upholding the quality of production. Beyond addressing these management challenges, bio cellmes offers a comprehensive system for tracking products and managing the entire production workflow, which encompasses everything from initial job preparations and the production stages to final clearance processes. Additionally, the quality control aspect involves thorough inspections of both product and reagent quality, while quality assurance entails monitoring environmental factors, managing deviations, and conducting audits for the release of finished products, ensuring a robust and reliable production framework. Ultimately, this integrated system not only enhances operational efficiency but also contributes significantly to maintaining high standards in production quality.
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
Bio LIMS
Founded
2016
Website
www.biolims.net