Clearlane CAPA

Clearlane CAPA

Clearlane Apps
Sierra QMS

Sierra QMS

Sierra Labs
+
+

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About

Clearlane CAPA is a Jira Cloud app for quality and regulatory teams managing corrective and preventive actions in medical device, pharmaceutical and ISO 9001 manufacturing environments. Existing Jira work items—including complaints, nonconformities, deviations and audit findings—can become CAPAs without new issue types, workflows or fields. The guided process covers containment, Five Whys root-cause analysis, a signed action plan, linked Jira actions and a dated effectiveness check; an ineffective check returns to root-cause analysis. Teams can review similar CAPAs, search CAPA data with JQL, export CSV and generate a PDF evidence file with workflow history, actions, signatures and audit trail. CAPAs can also start from Jira Service Management requests. A read-only Rovo agent answers questions about CAPA records. Built on Atlassian Forge, the app keeps its records in the customer’s Atlassian site.

About

Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.

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 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

Audience

Quality, regulatory and CAPA owners at medical device, pharma and ISO 9001 manufacturers using Jira Cloud.

Audience

Organizations in need of a healthcare and life science Quality Management system

Support

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

Support

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

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$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 Version Not Supported
Free Trial Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

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:

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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 Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

Clearlane Apps
Founded: 2026
France
clearlaneapps.com/capa/

Company Information

Sierra Labs
United States
www.sierralabs.com/quality-management/

Alternatives

CAPA Manager

CAPA Manager

Adaptive Business Management Systems

Alternatives

Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS

QT9 QMS

QT9 Software
SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems
Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

CAPA Supported

Categories

CAPA Supported
Compliance Supported
Document Control Supported
Quality Management Supported
Risk Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Not Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Supported
Training Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Not Supported
Sarbanes-Oxley Compliance Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Not Supported
Periodic Review Supported
Version Control Supported

Document Version Control Features

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

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Not Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Risk Management Features

Alerts/Notifications Supported
Auditing Not Supported
Business Process Control Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Not Supported
Exceptions Management Supported
Internal Controls Management Supported
IT Risk Management Supported
Legal Risk Management Not Supported
Mobile Access Supported
Operational Risk Management Supported
Predictive Analytics Supported
Reputation Risk Management Not Supported
Response Management Supported
Risk Assessment Supported

Integrations

Atlassian Rovo Supported
Jira Supported
Jira Service Management Supported

Integrations

Atlassian Rovo Not Supported
Jira Not Supported
Jira Service Management Not Supported
Claim Clearlane CAPA and update features and information
Claim Clearlane CAPA and update features and information
Claim Sierra QMS and update features and information
Claim Sierra QMS and update features and information