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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

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

Screenshots View All

No images available

Integrations

Microsoft Word Yes 

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 

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