QMSCAPA Software for International and Quality Management Systems

The QMSCAPA single user license is FREE and sponsored by ABCI ISO Consultants

Download Files | Introduction | User Guide & Screen Shots | Multi-user License Prices

QMSCAPA stands for Quality Management System, Corrective Actions and Preventive Actions. QMSCAPA is a Microsoft Windows compatible computer application, which is designed to generate a CAPA log for a Quality Management System based upon the ISO 9001:2015 Standard, among others.

QMSCAPA includes measurement and monitoring tools, which includes Customer Satisfaction Surveys, On-time Delivery Log & Calculator, Internal Auditing reports, Management Review and more essentials.

Features in Version 2:

• Corrective Action Form & Log
• Custom CAPA form generator and CAPA report builder
• Customer Satisfaction Survey Log & Calculator
• Fault Tree software tool to assist with root cause analysis
• FDA 21 CFR 11 & 820 Compliance
• Five Why software tool to assist with root cause analysis;
• Graphical Charts for Quality Measurements, Key Performance Indicators, Customer Feed-back and CAPAs
• Internal Audit Plan and Internal Audit Report for multiple standards, including AS9100, AS9110, AS9120, IATF 16949, ISO 9001, ISO 13485, ISO 14001, ISO 17025, ISO 22716, ISO 27001, ISO 45001.
• Management System Dashboard for Measuring & Monitoring Over-all Performance and/or Quality
• Manufacturing & Production Quality Metrics Calculator
• Module for logging Corrective Actions and Preventive Actions
• Module for logging Customer Complaints and other feedback
• Module for maintaining a master document index and revision journal.
• Module for logging Non-Conforming Products
• Module for recording personnel competencies
• Module for evaluating outsources, suppliers and vendors
• Module for Employee Training Programs, Training Schedules and verification of training effectiveness
• Monitoring and Measuring Device Database
• Multilevel access security and control.
• On-time Delivery Log & Calculator
• Preventive Action Form & Log
• Purchasing Quality Metrics Calculator
• Risk Assessments and Management (Pre-mitigation & Post-mitigation)
• Sales Quality Metrics Calculator
• Support for multiple languages
• Support for multiple simultaneous users
• Much more ...

A Corrective Action Request and Preventative Action Request tracking software system is essential for any quality system. It is a regulatory requirement that the FDA and other international regulatory inspectors and ISO auditors consider mission critical. When implemented properly, a Corrective Action (CAPA) software system improves product quality and safety, increases customer satisfaction, and more importantly, contributes to FDA and ISO compliance.

Computer Requirements:

• Windows 7, Windows 8, Windows 10 or;
• Windows 2012, Windows 2016 and 2019 Server

ABCI recommends Windows 2016 Server, or higher with Remote Desktop Services (Remote Desktop Connections) for simultaneous multiple Remote Desktop Users.