Clearlane CAPAClearlane Apps
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Sierra QMSSierra Labs
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Related Products
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About
Clearlane CAPA is a Jira Cloud app for quality and regulatory teams managing corrective and preventive actions in medical device, pharmaceutical and ISO 9001 manufacturing environments. Existing Jira work items—including complaints, nonconformities, deviations and audit findings—can become CAPAs without new issue types, workflows or fields. The guided process covers containment, Five Whys root-cause analysis, a signed action plan, linked Jira actions and a dated effectiveness check; an ineffective check returns to root-cause analysis. Teams can review similar CAPAs, search CAPA data with JQL, export CSV and generate a PDF evidence file with workflow history, actions, signatures and audit trail. CAPAs can also start from Jira Service Management requests. A read-only Rovo agent answers questions about CAPA records. Built on Atlassian Forge, the app keeps its records in the customer’s Atlassian site.
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About
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Quality, regulatory and CAPA owners at medical device, pharma and ISO 9001 manufacturers using Jira Cloud.
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Audience
Organizations in need of a healthcare and life science Quality Management system
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
$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 Version
Not Supported
Free Trial
Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Company InformationClearlane Apps
Founded: 2026
France
clearlaneapps.com/capa/
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Company InformationSierra Labs
United States
www.sierralabs.com/quality-management/
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Categories |
Categories |
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CAPA Features
Audit Management
Supported
CAPA Planning
Not Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Not Supported
Audit Management
Supported
Compliance Tracking
Supported
Controls Testing
Not Supported
Environmental Compliance
Supported
FDA Compliance
Supported
HIPAA Compliance
Not Supported
Incident Management
Supported
ISO Compliance
Supported
OSHA Compliance
Supported
Risk Management
Not Supported
Sarbanes-Oxley Compliance
Supported
Surveys & Feedback
Supported
Version Control
Supported
Workflow / Process Automation
Supported
Document Control Features
Archiving & Retention
Supported
Automated Routing
Supported
Change Management
Supported
Compliance Management
Supported
Electronic Signature
Supported
Escalation Management
Not Supported
Periodic Review
Supported
Version Control
Supported
Document Version Control Features
Access Controls/Permissions
Supported
Approval Process Control
Supported
Archiving & Retention
Supported
Audit Trail
Supported
Commenting / Notes
Supported
Document Check-in / Check-out
Supported
For Engineering Documents
Supported
Revision History
Supported
Version Comparison
Supported
Version Rollback
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Not Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Risk Management Features
Alerts/Notifications
Supported
Auditing
Not Supported
Business Process Control
Supported
Compliance Management
Supported
Corrective Actions (CAPA)
Supported
Dashboard
Not Supported
Exceptions Management
Supported
Internal Controls Management
Supported
IT Risk Management
Supported
Legal Risk Management
Not Supported
Mobile Access
Supported
Operational Risk Management
Supported
Predictive Analytics
Supported
Reputation Risk Management
Not Supported
Response Management
Supported
Risk Assessment
Supported
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Integrations
Atlassian Rovo
Supported
Jira
Supported
Jira Service Management
Supported
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Integrations
Atlassian Rovo
Not Supported
Jira
Not Supported
Jira Service Management
Not Supported
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