KOŚA DMSKOŚA
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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
KOŚA DMS is a cloud-based document management system for pharmaceutical, biotechnology, medical-device and other life-sciences organizations. It supports controlled document creation, review, approval, release, distribution and revision tracking, with workflows for SOPs, policies, forms and other quality records. Teams can manage role-based access, electronic signatures, audit trails, periodic reviews and controlled copies to maintain traceable document histories for regulated processes. Microsoft Word integration supports document drafting within familiar authoring workflows, while ERP and LIMS connections can link documentation with operational systems. The system is intended for quality assurance, quality control, regulatory affairs and document-control teams that need to coordinate document lifecycle activities across sites, functions and regulated operations.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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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 manufacturers, biotechnology companies, medical device manufacturers, contract manufacturing organizations (CMOs), CDMOs, clinical research organizations (CROs), laboratories, and life sciences companies. Ideal for Quality Assurance, Quality Control, Regulatory Affairs, Compliance, and Document Control teams.
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Support
Phone Support
Not Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Not Supported
In Person
Supported
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Company InformationAgatha
Founded: 2015
United States
en.agathalife.com
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Company InformationKOŚA
Founded: 2025
India
kosa-ai.com/pharmaceutical-document-management-system/
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Categories |
Categories |
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Integrations
Microsoft Word
Not Supported
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