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Description

Clearlane CAPA is an innovative app designed for Jira Cloud, specifically tailored for teams involved in quality and regulatory compliance within sectors such as medical devices, pharmaceuticals, and ISO 9001 manufacturing. It allows for the transformation of existing Jira work items—such as complaints, nonconformities, deviations, and audit findings—into CAPAs without the need for additional issue types, workflows, or fields. The application facilitates a structured process that encompasses containment measures, a Five Whys root-cause analysis, the formulation of a signed action plan, connections to Jira actions, and a scheduled effectiveness evaluation; if the effectiveness check is deemed insufficient, it loops back to the root-cause analysis phase. Users have the ability to review related CAPAs, utilize JQL for CAPA data searches, export information to CSV format, and create PDF documentation that includes workflow history, actions taken, signatures, and a comprehensive audit trail. Additionally, CAPAs can be initiated directly from requests made through Jira Service Management, and a read-only Rovo agent is available to field inquiries regarding CAPA records. Built upon the Atlassian Forge platform, this app ensures that all records are securely maintained within the customer’s Atlassian environment, providing a seamless integration experience. This unique approach enhances the efficiency and effectiveness of quality management processes for teams in regulated industries.

Description

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes. The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records. Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards. Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes: • Audit-proven insights • Guidance from compliance specialists • Continuous system validation • User training • 24/7 global support • Smooth implementation and data migration • Dedicated Customer Success Experts With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Atlassian Rovo Yes 
Jira Yes 
Jira Service Management Yes 
Microsoft 365 No 
Microsoft Entra ID No 

Integrations

Atlassian Rovo No 
Jira No 
Jira Service Management No 
Microsoft 365 Yes 
Microsoft Entra ID Yes 

Pricing Details

$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 Yes 
Free Version No 

Pricing Details

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Clearlane Apps

Founded

2026

Country

France

Website

clearlaneapps.com/capa/

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management No 
Forms Management Yes 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning No 
Risk Assessment Yes 
Workflow Management Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis No 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

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

Quality Management

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

Alternatives

No Alternatives

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