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
QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.
API Access
Has API
Yes
API Access
Has API
No
Screenshots View All
No images available
Integrations
Microsoft Word
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
$17/month/user
Free Trial
Yes
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
No
Live Rep (24/7)
No
Online Support
Yes
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
No
Vendor Details
Company Name
KOŚA
Founded
2025
Country
India
Website
kosa-ai.com/pharmaceutical-document-management-system/
Vendor Details
Company Name
QFacts
Founded
2024
Country
Belgium
Website
qfacts.be
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
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No