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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 Risk Register is a comprehensive risk-management tool designed for Jira Cloud, enabling teams to document, evaluate, manage, review, and archive evidence pertaining to project risks directly within the Jira platform. The app features a scoring system based on a 5 × 5 matrix, allowing for assessments to be conducted both prior to and following treatment, while also offering templates that comply with various standards such as ISO 14971, FMEA, ISO 27001, NIS2, CRA, and DORA workflows. Treatment strategies and subsequent actions are meticulously tracked as Jira work items, each assigned an owner, status, and due date for effective management. Teams benefit from scheduled review intervals, reminder alerts, and signed reviews that support maintaining an auditable trail, while PDF files are utilized to compile all assessment and treatment details. This application is specifically designed for quality assurance, product safety, risk management, and security teams utilizing Jira Cloud, catering particularly to medical-device companies and groups addressing security and regulatory risk frameworks. Additionally, the tool enhances collaboration among team members by streamlining the risk management process within their existing project workflows.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Jira Yes 
Atlassian Rovo Yes 
Jira Service Management Yes 

Integrations

Jira Yes 
Atlassian Rovo 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.
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/risk-register/

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

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment No