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What is FMEA Database?

SBS FMEA Database is affordable risk and opportunity management software designed to support ISO 9001 risk-based thinking and help organizations prepare for the ISO 9001:2026 requirements. Create and manage FMEAs to identify failure modes, causes and effects, assess risk, calculate Risk Priority Numbers (RPNs), assign actions, and track risk reduction. Integrated SWOT analysis helps organizations evaluate strengths, weaknesses, opportunities, and threats and document strategic risks and opportunities. Centralized records improve traceability, consistency, collaboration, and reporting compared with spreadsheets. SBS FMEA Database helps manufacturers and other quality-focused organizations integrate FMEA, SWOT, risk management, and continual improvement into their QMS.

What is Clearlane Risk Register?

Clearlane Risk Register serves as a robust tool for risk management tailored for Jira Cloud, empowering teams to systematically document, assess, handle, review, and archive project risk-related evidence right within the Jira interface. It incorporates a scoring mechanism based on a 5 × 5 matrix, facilitating evaluations both before and after implementing treatment, while also providing templates aligned with standards such as ISO 14971, FMEA, ISO 27001, NIS2, CRA, and DORA workflows. The application meticulously tracks treatment strategies and follow-up actions as Jira work items, assigning each a designated owner, status, and due date to ensure effective oversight. Additionally, teams benefit from scheduled review periods, reminder notifications, and documented reviews to maintain a clear audit trail, with PDF files compiling all assessment and treatment information. Specifically designed for teams in quality assurance, product safety, risk management, and security within Jira Cloud, it is particularly beneficial for medical-device companies and those navigating security and regulatory frameworks. Furthermore, the tool fosters improved collaboration among team members by optimizing the risk management process and integrating it smoothly into their existing project workflows, ultimately enhancing overall project efficiency.

Media

Media

Integrations Supported

Azure SQL Database
Microsoft 365
Sunday Business Systems

Integrations Supported

Jira

API Availability

API Availability

Pricing Information

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

Pricing Information

$0
Free for up to 10 users.
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Standard Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub

Company Facts

Organization Name

Sunday Business Systems

Date Founded

2004

Company Location

United States

Company Website

sundaybizsys.com/fmea-database/

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/risk-register/

Categories and Features

FMEA

Not specified

ISO Compliance

Not specified

Risk Management

Compliance Management
Corrective Actions (CAPA)
Internal Controls Management
Legal Risk Management
Operational Risk Management
Reputation Risk Management
Response Management
Risk Assessment

Categories and Features

Risk Management

Not specified

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