Clearlane Risk RegisterClearlane Apps
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FMEA DatabaseSunday Business Systems
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Related Products
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About
Clearlane Risk Register is a risk-management app for Jira Cloud that lets teams record, assess, treat, review and retain evidence for project risks within Jira. Risks can be scored on a 5 × 5 map, with assessments before and after treatment, and templates support ISO 14971, FMEA, ISO 27001, NIS2, CRA and DORA workflows. Treatment decisions and follow-up actions are tracked as Jira work items with owners, statuses and due dates. Review intervals, reminders, signed reviews and a history help teams maintain an auditable record, while PDF evidence files collect assessment and treatment information. The app is built for quality, product-safety, risk and security teams using Jira Cloud, including medical-device organizations and teams working with security and regulatory risk frameworks.
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About
Build a simple and efficient Quality Management System (QMS). Install on your local server or leverage our Cloud QMS solution. Implement risk based thinking required by ISO 9001:2015. Risk Assessment: Failure Modes and Effects Analysis (FMEA). Implement risk based strategies for ISO 9001:2015, ISO 14971. Identify failure modes for each process or item. Identify effects and severity. Identify causes and frequency. Identify current controls and detection levels. Develop multiple actions associated with this failure mode. Assign owners and due dates. Establish verification and validation criteria. Electronic signature for management approval. User login: define user passwords and privileges. Rich set of reports. Track open actions and delinquent due dates. Free runtime version of Access is available from Microsoft. Export data to Excel for further analysis. Common, convenient software platform.
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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
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Quality, risk and security teams at medical device manufacturers, NIS2 entities and ISO 27001 organizations using Jira Cloud.
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Audience
Researchers and companies seeking a quality management system solution
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Not 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
$0
Free for up to 10 users.
Free Version
Supported
Free Trial
Supported
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Pricing
$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent users.
Free Version
Supported
Free Trial
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
Supported
Live Online
Supported
In Person
Not Supported
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Company InformationClearlane Apps
Founded: 2026
France
clearlaneapps.com/risk-register/
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Company InformationSunday Business Systems
Founded: 2004
United States
sundaybizsys.com/fmea-database/
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Alternatives |
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Categories |
Categories |
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Risk Management Features
Alerts/Notifications
Not Supported
Auditing
Not Supported
Business Process Control
Not Supported
Compliance Management
Supported
Corrective Actions (CAPA)
Supported
Dashboard
Not Supported
Exceptions Management
Not Supported
Internal Controls Management
Supported
IT Risk Management
Not Supported
Legal Risk Management
Supported
Mobile Access
Not Supported
Operational Risk Management
Supported
Predictive Analytics
Not Supported
Reputation Risk Management
Supported
Response Management
Supported
Risk Assessment
Supported
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Integrations
Azure SQL Database
Not Supported
Jira
Supported
Microsoft 365
Not Supported
Sunday Business Systems
Not Supported
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Integrations
Azure SQL Database
Supported
Jira
Not Supported
Microsoft 365
Supported
Sunday Business Systems
Supported
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