KOŚA DMSKOŚA
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RegDocs365Court Square Group
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Related Products
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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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About
Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.
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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
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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Audience
Pharmaceutical, biotech, life science, medical device vendors, and more
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Not Supported
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API
Offers API
Supported
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API
Offers API
Not 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
Supported
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PricingPer user, Per month
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Supported
Live Online
Not Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Company InformationKOŚA
Founded: 2025
India
kosa-ai.com/pharmaceutical-document-management-system/
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Company InformationCourt Square Group
Founded: 1995
United States
www.regdocs365.com
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Alternatives |
Alternatives |
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Categories |
Categories |
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Clinical Trial Management Features
21 CFR Part 11 Compliance
Supported
Document Management
Supported
Electronic Data Capture
Supported
Enrollment Management
Not Supported
HIPAA Compliant
Supported
Monitoring
Not Supported
Patient Database
Not Supported
Recruiting Management
Not Supported
Scheduling
Not Supported
Study Planning
Not Supported
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Integrations
Crow Canyon Contract Management
Not Supported
Microsoft Word
Supported
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Integrations
Crow Canyon Contract Management
Supported
Microsoft Word
Not Supported
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