Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • SBS Quality Management Software Reviews & Ratings
    7 Ratings
    Company Website
  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    66 Ratings
    Company Website
  • isoTracker Quality Management Reviews & Ratings
    19 Ratings
    Company Website
  • AlisQI Reviews & Ratings
    108 Ratings
    Company Website
  • Process Street Reviews & Ratings
    1,119 Ratings
    Company Website
  • Epsilon3 Reviews & Ratings
    265 Ratings
    Company Website
  • Propel Reviews & Ratings
    215 Ratings
    Company Website
  • Epicor Connected Process Control Reviews & Ratings
    4 Ratings
    Company Website
  • HSI Donesafe Reviews & Ratings
    176 Ratings
    Company Website
  • Mitti (by SafetyCulture) Reviews & Ratings
    869 Ratings
    Company Website

What is QFacts?

QFacts is an all-encompassing cloud-driven Quality Management System tailored for pharmacies, compounding facilities, and other regulated industries. It manages the full spectrum of the quality lifecycle, offering features such as controlled document management with versioning and approval processes, training and competency tracking aligned with specific curricula, and comprehensive event and complaint management that includes root cause analysis, CAPA management, and change control, all while maintaining detailed audit trails. Designed to meet GAMP 5 requirements, it also adheres to European GMP and GDP regulations, utilizing role-based access controls that integrate across various organizations, locations, and departments. Quality managers benefit from customizable review workflows, the ability to monitor due dates, and compliance oversight through real-time dashboards. Every action within the system is logged meticulously, ensuring a transparent accountability chain for inspectors and auditors, from document approval to training completion and the resolution of corrective measures. This thorough level of oversight not only boosts operational efficiency but also instills greater reliability within quality management processes. As a result, QFacts positions itself as an essential tool for organizations striving to maintain high standards of quality and compliance.

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

No images available

Media

Integrations Supported

Integrations Supported

Atlassian Rovo
Jira
Jira Service Management

API Availability

API Availability

Pricing Information

$17/month/user
Free Trial Offered?

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
Online Training

Training Options

Documentation Hub

Company Facts

Organization Name

QFacts

Date Founded

2024

Company Location

Belgium

Company Website

qfacts.be

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/capa/

Categories and Features

Quality Management

Not specified

Categories and Features

CAPA

Not specified

Popular Alternatives

Popular Alternatives

No Alternatives
Dot Compliance QMS Reviews & Ratings

Dot Compliance QMS

QMS for Life Sciences
QualityPro by TecWork Reviews & Ratings

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.