QEdgeSarjen Systems Pvt Ltd
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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
Sarjen's QEdge stands as a robust, risk-based enterprise Quality Management System, meticulously designed for the pharmaceutical manufacturing and broader life sciences industries. This comprehensive solution adeptly streamlines crucial quality processes, including Change Control, Deviation management, CAPA, efficient Document Management, and automated Training with SCORM-based eLearning. QEdge ensures stringent and full compliance with major regulatory standards such as FDA, EU-GMP, and ICH guidelines. By fostering operational excellence, maintaining impeccable data integrity, and guaranteeing audit-readiness in complex GxP environments, QEdge significantly enhances overall quality management. It provides essential process control and simplified vendor qualification, driving efficiency and superior quality across all operations.
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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
Companies searching for a solution to optimize the quality of various processes
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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 InformationSarjen Systems Pvt Ltd
Founded: 1998
India
qedge.sarjen.com
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Alternatives |
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Categories |
Categories |
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Quality Management Features
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
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Integrations
SAP Store
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