Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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