Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
KOŚA DMS is a comprehensive cloud document management solution tailored for organizations in the pharmaceutical, biotechnology, medical device, and broader life sciences sectors. It facilitates the creation, evaluation, authorization, distribution, and revision tracking of controlled documents, incorporating workflows for standard operating procedures (SOPs), policies, forms, and other essential quality records. With the ability to manage role-specific access, electronic signatures, audit trails, and periodic reviews, teams can ensure that document histories remain traceable for regulated processes. Integration with Microsoft Word enhances the drafting process, allowing users to work within a familiar authoring environment, while connections to ERP and LIMS systems enable seamless documentation linkage with operational workflows. Designed specifically for quality assurance, quality control, regulatory affairs, and document control teams, this system streamlines the coordination of document lifecycle activities across various sites and functions, ensuring compliance with industry regulations. Furthermore, the platform's user-friendly interface allows teams to efficiently navigate and manage their document processes without unnecessary complications.
Description
A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.
API Access
Has API
Yes
API Access
Has API
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
Per user, Per month
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
KOŚA
Founded
2025
Country
India
Website
kosa-ai.com/pharmaceutical-document-management-system/
Vendor Details
Company Name
Court Square Group
Founded
1995
Country
United States
Website
www.regdocs365.com
Product Features
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
Yes
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No