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Average Ratings 0 Ratings

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features
design
support

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Write a Review

Description

Clearlane CAPA is an innovative app designed for Jira Cloud, specifically tailored for teams involved in quality and regulatory compliance within sectors such as medical devices, pharmaceuticals, and ISO 9001 manufacturing. It allows for the transformation of existing Jira work items—such as complaints, nonconformities, deviations, and audit findings—into CAPAs without the need for additional issue types, workflows, or fields. The application facilitates a structured process that encompasses containment measures, a Five Whys root-cause analysis, the formulation of a signed action plan, connections to Jira actions, and a scheduled effectiveness evaluation; if the effectiveness check is deemed insufficient, it loops back to the root-cause analysis phase. Users have the ability to review related CAPAs, utilize JQL for CAPA data searches, export information to CSV format, and create PDF documentation that includes workflow history, actions taken, signatures, and a comprehensive audit trail. Additionally, CAPAs can be initiated directly from requests made through Jira Service Management, and a read-only Rovo agent is available to field inquiries regarding CAPA records. Built upon the Atlassian Forge platform, this app ensures that all records are securely maintained within the customer’s Atlassian environment, providing a seamless integration experience. This unique approach enhances the efficiency and effectiveness of quality management processes for teams in regulated industries.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Atlassian Rovo Yes 
Confluence No 
Jira Yes 
Jira Service Management Yes 

Integrations

Atlassian Rovo Yes 
Confluence Yes 
Jira No 
Jira Service Management No 

Pricing Details

$10/month
Plans start at $10/month for up to 10 users. Larger teams pay per user, billed monthly or yearly through Atlassian Marketplace. A free trial is available with every plan. There is no setup fee.
Free Trial Yes 
Free Version No 

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 

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 No 
Live Rep (24/7) No 
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 No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Clearlane Apps

Founded

2026

Country

France

Website

clearlaneapps.com/capa/

Vendor Details

Company Name

Clearlane Apps

Founded

2026

Country

France

Website

clearlaneapps.com/controlled-documents/

Product Features

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management 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