Clearlane Risk Register

Clearlane Risk Register

Clearlane Apps
FMEA Database

FMEA Database

Sunday Business Systems
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+

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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.

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.

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

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

Audience

Quality, risk and security teams at medical device manufacturers, NIS2 entities and ISO 27001 organizations using Jira Cloud.

Audience

Researchers and companies seeking a quality management system solution

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

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

Pricing

$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent users.
Free Version Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Company Information

Clearlane Apps
Founded: 2026
France
clearlaneapps.com/risk-register/

Company Information

Sunday Business Systems
Founded: 2004
United States
sundaybizsys.com/fmea-database/

Alternatives

Alternatives

DataLyzer FMEA

DataLyzer FMEA

DataLyzer International
SBS Quality Database

SBS Quality Database

Sunday Business Systems
Clearlane CRA

Clearlane CRA

Clearlane Apps
Rizzqo

Rizzqo

Rizzqo GmbH
SoftExpert FMEA

SoftExpert FMEA

SoftExpert

Categories

Risk Management Supported

Categories

FMEA Supported
ISO Compliance Supported
Risk Management Supported

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

Integrations

Azure SQL Database Not Supported
Jira Supported
Microsoft 365 Not Supported
Sunday Business Systems Not Supported

Integrations

Azure SQL Database Supported
Jira Not Supported
Microsoft 365 Supported
Sunday Business Systems Supported
Claim Clearlane Risk Register and update features and information
Claim Clearlane Risk Register and update features and information
Claim FMEA Database and update features and information
Claim FMEA Database and update features and information