KOŚA DMS

KOŚA DMS

KOŚA
RegDocs365

RegDocs365

Court Square Group
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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.

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.

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

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

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.

Audience

Pharmaceutical, biotech, life science, medical device vendors, and more

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Not Supported

API

Offers API Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Supported

Pricing

Per user, Per month
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Not Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

KOŚA
Founded: 2025
India
kosa-ai.com/pharmaceutical-document-management-system/

Company Information

Court Square Group
Founded: 1995
United States
www.regdocs365.com

Alternatives

Interfacing Integrated Management System (IMS)

Interfacing Integrated Management System (IMS)

Interfacing Technologies Corporation

Alternatives

Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
Gavel

Gavel

Gavel.io
LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
cubeCTMS

cubeCTMS

CRScube

Categories

Categories

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

Integrations

Crow Canyon Contract Management Not Supported
Microsoft Word Supported

Integrations

Crow Canyon Contract Management Supported
Microsoft Word Not Supported
Claim KOŚA DMS and update features and information
Claim KOŚA DMS and update features and information
Claim RegDocs365 and update features and information
Claim RegDocs365 and update features and information