Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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.

Description

Create a simple, efficient Quality Management System (QMS). You can install on your local server, or use our Cloud QMS solution. ISO 9001:2015 requires risk-based thinking. Risk Assessment: Failure Modes Analysis (FMEA) Implement risk-based strategies for ISO 9001, ISO 14971. Identify failure modes for each item or process. Identify the effects and severity. Identify the causes and frequency. Identify current controls and detection levels. Multiple actions should be taken in response to this failure mode. Assign owners and due dates. Establish verification and validation criteria. Management approval can be obtained by electronic signature. User login: Define passwords and privileges. Rich set of reports. Track open actions and delinquent due date. Microsoft Access is free to download. To further analyze the data, export it to Excel. Common, easy-to-use software platform

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Azure SQL Database No 
Jira Yes 
Microsoft 365 No 
Sunday Business Systems No 

Integrations

Azure SQL Database Yes 
Jira No 
Microsoft 365 Yes 
Sunday Business Systems Yes 

Pricing Details

$0
Free for up to 10 users.
Free Trial Yes 
Free Version Yes 

Pricing Details

$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent 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 Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Clearlane Apps

Founded

2026

Country

France

Website

clearlaneapps.com/risk-register/

Vendor Details

Company Name

Sunday Business Systems

Founded

2004

Country

United States

Website

sundaybizsys.com/fmea-database/

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 

Product Features

Risk Management

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

Alternatives

No Alternatives

Alternatives

SBS Quality Database Reviews

SBS Quality Database

Sunday Business Systems
DataLyzer FMEA Reviews

DataLyzer FMEA

DataLyzer International