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What is Qsoft FRACAS?

The Failure Reporting, Analysis, and Corrective Action System (FRACAS) functions as an all-encompassing feedback tool that encourages cooperation between users and suppliers to collect, record, and assess failures associated with both hardware and software systems. In the early stages of design evolution, implementing corrective actions (CAR) is most efficient; however, as the design becomes more established, these implementations tend to incur higher costs and face greater limitations. This analytical framework identifies essential corrective actions that need to be executed and validated to prevent future failures. By promoting reliability improvements throughout the equipment's entire lifecycle, FRACAS can be utilized during numerous testing stages, including in-house laboratory assessments, field trials (both alpha and beta), and production processes, allowing stakeholders to pinpoint and rectify recurring issues within the equipment's design. Ultimately, this structured methodology not only boosts product reliability but also leads to a more streamlined approach for resolving problems effectively. In addition, the continuous use of FRACAS fosters a culture of proactive risk management that can significantly enhance the overall quality of products.

What is Clearlane CAPA?

Clearlane CAPA is a cutting-edge application designed for Jira Cloud, specifically aimed at teams working in quality and regulatory compliance across industries like medical devices, pharmaceuticals, and ISO 9001 manufacturing. This app enables teams to convert existing Jira work items—such as complaints, nonconformities, deviations, and audit findings—into CAPAs without requiring extra issue types, workflows, or fields. It streamlines a systematic approach that includes containment measures, a Five Whys root-cause analysis, the development of a signed action plan, links to Jira actions, and a planned effectiveness evaluation; if the effectiveness assessment is found lacking, it reverts to the root-cause analysis stage. Users can also examine associated CAPAs, leverage JQL for CAPA data inquiries, export data in CSV format, and generate PDF documentation that encompasses workflow history, actions taken, signatures, and a thorough audit trail. Moreover, CAPAs can be initiated directly from requests submitted via Jira Service Management, and a read-only Rovo agent is available to address questions about CAPA records. Built on the Atlassian Forge platform, this application guarantees that all records are securely housed within the customer's Atlassian environment, ensuring a seamless integration experience. By adopting this distinctive method, teams in regulated sectors can significantly boost the efficiency and effectiveness of their quality management processes, ultimately leading to improved compliance outcomes. The app's user-friendly interface further enhances its accessibility, making it a valuable tool for organizations striving to maintain high standards in quality assurance.

Media

Media

Integrations Supported

Integrations Supported

Atlassian Rovo
Jira
Jira Service Management

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

$59/month
$59/month up to 10 users, then per user; billed by the Atlassian Marketplace, monthly or annual; 30-day free trial
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub

Company Facts

Organization Name

Qsoft

Company Website

www.qsoft.cc/qsoft_website/FRACAS.aspx

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/capa/

Categories and Features

CAPA

Not specified

Categories and Features

CAPA

CAPA Planning
Nonconformance Tracking
Root Cause Analysis

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