Related Products
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About
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11.
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About
QbDVision is a structured, cloud-based Digital CMC platform designed to accelerate drug development by transforming dispersed scientific data into actionable process intelligence. It enables pharmaceutical and biotech teams to capture, organize, and connect product and manufacturing knowledge across the entire development lifecycle, replacing siloed spreadsheets and document-centric workflows with a unified, data-centric framework. Its multidimensional architecture provides visibility into every input, variable, and objective within development processes, allowing users to evaluate how changes may impact downstream outcomes and overall product quality. By structuring data with standardized vocabularies and contextual relationships, the platform supports risk-based decision making, improves collaboration, and strengthens regulatory readiness.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Clinical-operations, regulatory-affairs and quality-assurance teams searching for a tool to support studies, audits and global operations
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Audience
Pharmaceutical and biotech development teams interested in a platform to manage and optimize CMC data and workflows
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationAgatha
Founded: 2015
United States
en.agathalife.com
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Company InformationQbDVision
United States
www.qbdvision.com
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Categories |
Categories |
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Integrations
No info available.
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Integrations
No info available.
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