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Average Ratings 0 Ratings

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features
design
support

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Write a Review

Description

Clearlane Controlled Documents integrates document control specifically designed for quality management systems within Confluence Cloud, effectively transforming standard pages like SOPs, work instructions, and policies into regulated documents. Each revision is authenticated by named approvers who utilize a unique personal signing password; the electronic signature is intricately linked to the content through a SHA-256 fingerprint, ensuring that any edits made during the review process invalidate the signature. Once the final signature is obtained, the revision is deemed effective and assigned a subsequent review date. Readers assure themselves of the current revision, periodic reviews activate reminder notifications, and a register maintains a record of all documents within each space. Users have the capability to create a comprehensive evidence PDF that includes signatures, revision history, read confirmations, and the audit trail. This application caters to teams in pharma, biotech, medtech, and ISO 9001 quality sectors, and it is available in English, French, and German languages. It also assists teams in adhering to regulations such as 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 standards. Developed on the Atlassian Forge platform, it securely stores data within the customer's own Atlassian environment, ensuring both compliance and data integrity. Additionally, it offers an intuitive interface that simplifies the management of controlled documents for users across various industries.

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.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Atlassian Rovo Yes 
Confluence Yes 
Microsoft Word No 

Integrations

Atlassian Rovo No 
Confluence No 
Microsoft Word Yes 

Pricing Details

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

Pricing Details

No price information available.
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 No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) No 
In Person Yes 

Vendor Details

Company Name

Clearlane Apps

Founded

2026

Country

France

Website

clearlaneapps.com/controlled-documents/

Vendor Details

Company Name

KOŚA

Founded

2025

Country

India

Website

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

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 

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 

Alternatives

No Alternatives

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