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Average Ratings 0 Ratings

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features
design
support

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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

QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

Atlassian Rovo Yes 
Jira Yes 
Jira Service Management Yes 

Integrations

Atlassian Rovo No 
Jira No 
Jira Service Management No 

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/month/user
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 No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

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

Customer Support

Business Hours No 
Live Rep (24/7) No 
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

QFacts

Founded

2024

Country

Belgium

Website

qfacts.be

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

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Alternatives

No Alternatives
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