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
Amid escalating pharmaceutical supply chain regulations, manufacturers, distributors, and 3PLs face mounting costs and non-compliance risks threatening revenue. LighthouseAI™ leverages compliance automation to solve compliance challenges, while reducing your stress and workload. Compliance is achieved in minutes, not days, resulting in the protection of your revenue stream from any adverse actions. Generate immediate compliance assessments for your facilities and erase hours of manual research to focus on actionable items. Receive instant regulatory updates and notifications regarding new and changing requirements and legislation relevant to your facilities. Organize your data on a single platform to achieve transparency with a bird’s eye view of your compliance activities.
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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 businesses interested in a platform to solve compliance by leveraging AI
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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 InformationLighthouseAI
Founded: 2023
United States
lighthouseai.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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