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What is KOŚA DMS?

KOŚA DMS is an all-encompassing cloud-based document management system designed for organizations operating in the pharmaceutical, biotechnology, medical device, and wider life sciences industries. It supports the development, review, approval, distribution, and tracking of controlled documents, while also incorporating workflows for standard operating procedures (SOPs), policies, forms, and vital quality records. The solution offers role-based access control, electronic signatures, audit trails, and periodic review features, enabling teams to maintain a clear and compliant document history for regulated activities. Its integration with Microsoft Word simplifies the drafting process, allowing users to create documents in an environment they are already comfortable with, while links to ERP and LIMS systems provide seamless connections to operational workflows. Tailored for teams in quality assurance, quality control, regulatory affairs, and document control, KOŚA DMS effectively coordinates document lifecycle management across multiple locations and functions, fostering adherence to industry regulations. Moreover, the intuitive interface enhances user experience, enabling teams to manage their document processes with ease and efficiency, thereby minimizing potential disruptions. This comprehensive approach not only streamlines operations but also promotes organizational efficiency and compliance.

What is Clearlane Controlled Documents?

Clearlane Controlled Documents provides a specialized document control system tailored for quality management frameworks within Confluence Cloud, effectively converting standard documentation such as SOPs, work instructions, and policies into regulated entries. Each document revision is verified by designated approvers who employ a distinctive personal signing password; this electronic signature is meticulously connected to the document content via a SHA-256 fingerprint, guaranteeing that any modifications during the review process will render the signature invalid. Upon securing the final signature, the revision is recognized as effective and is assigned a future review date. Readers can confirm that they are viewing the latest revision, and regular reviews trigger reminder notifications, while a comprehensive register tracks all documents within each designated space. Users can also generate a detailed evidence PDF, which encompasses signatures, revision histories, read confirmations, and an audit trail. This solution is ideal for teams operating in the pharmaceutical, biotech, medtech, and ISO 9001 quality sectors, and it is offered in English, French, and German. Furthermore, it supports compliance with regulations such as 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 standards. Built on the Atlassian Forge platform, it ensures that data is securely stored within the client’s Atlassian environment, thus maintaining both compliance and data integrity. The application also features a user-friendly interface that facilitates the management of controlled documents for users in a variety of industries, making it an invaluable tool for maintaining regulatory standards and improving organizational efficiency.

Media

Media

Integrations Supported

Microsoft Word

Integrations Supported

Atlassian Rovo
Confluence

API Availability

Has API

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

$0
Free for up to 10 users. Larger teams pay per user, billed by Atlassian through the Marketplace.
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

KOŚA

Date Founded

2025

Company Location

India

Company Website

kosa-ai.com/pharmaceutical-document-management-system/

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/controlled-documents/

Categories and Features

Document Control

Not specified

Document Management

Not specified

Document Workflow

Not specified

Categories and Features

Document Control

Not specified

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