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What is Sierra QMS?

Workflows are meticulously designed to aid in the preparation of all essential elements needed for a 510(k) submission, while also guaranteeing adherence to the quality record standards outlined in 21 CFR Part 820 as you get ready to launch your device. These workflows are equipped with tools that simplify the creation of vital policies, procedures, and work instructions. In addition, you can keep track of non-conformances, deviations, and CAPAs with custom quality management reports. As your processes develop and improve, automatic training updates ensure your team remains informed. The system also streamlines validation testing for devices, applications, websites, and bespoke software tailored to meet your business requirements. This automation greatly diminishes the time and resources typically needed for comprehensive testing, reporting, and approval tasks. Moreover, you can consolidate all your policies, procedures, and artifacts into standardized documents, making them easily accessible for audit assessments. This solution not only simplifies compliance and validation procedures but also significantly boosts operational efficiency. By integrating such advanced workflows, organizations can enhance their overall productivity and adaptability in a competitive market.

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

$10/month
Plans start at $10/month for up to 10 users. Larger teams pay per user, billed monthly or yearly through Atlassian Marketplace. A free trial is available with every plan. There is no setup fee.
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

Sierra Labs

Company Location

United States

Company Website

www.sierralabs.com/quality-management/

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/capa/

Categories and Features

CAPA

Audit Management
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Periodic Review
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

Alerts/Notifications
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Exceptions Management
IT Risk Management
Internal Controls Management
Mobile Access
Operational Risk Management
Predictive Analytics
Response Management
Risk Assessment

Categories and Features

CAPA

Not specified

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