ISO Management System Software

 

QMSCAPA everywhere you need it

QMSCAPA Online User Guidance, 2.23.8* | What's new in QMSCAPA?

 

Adding an effective software tool like QMSCAPA™ to your quality and ISO management systems is a great way to improve quality, and other management systems, through the efficient accumulation and analysis of information. If you are implementing a ISO management system then you will quickly learn how QMSCAPA can make the work of implementation easier and faster.

 

The single-user version of QMSCAPA™ is *License FREE

Join our user-group and Download QMSCAPA License FREE

 

*License free means, free to use and free to share.

 

QMSCAPA™ stands for Quality Management System, Corrective Actions and Preventive Actions (CAPA). However, QMSCAPA™ provides many of the tools necessary to maintain an excellent quality management system and other International Management Systems.

 

QMSCAPA™ is designed by a user group of Quality Managers, Environmental Compliance Managers, Information Security Managers, Occupational Health & Safety Professionals, including assessors, auditors, consultants and compliance managers for management systems.

 

If you have not joined our QMSCAPA user group, we encourage your joining and welcome your input on how we can improve QMSCAPA.

 

QMSCAPA™ includes tools for Nonconformance and Corrective Actions

QMSCAPA™ includes tools for electronic approval and control of documented information.

QMSCAPA™ includes tools for accessing documented information at the distributed point of use.

QMSCAPA™ provides tools for collecting and management Customer Feed-back, including complaints, RMAs and recalls.

QMSCAPA™ provides tools for conducting Customer Satisfaction Surveys and evaluations, including survey forms, data collection and analysis.

QMSCAPA™ provides tools for conducting supplier surveys, supplier evaluations and supplier report card (aka score cards).

QMSCAPA™ provides tools for constructing, and maintaining documents (Rich Text Format).

QMSCAPA™ provides tools for risk assessments, managing risk and opportunities.

QMSCAPA™ provides tools for monitoring and measuring Objectives and Processes, including trend analysis charts and reports.

QMSCAPA™ provides two tools for root cause analysis, which use the "5 Why" and "Fault-tree" methods.

 

QMSCAPA™ is a Microsoft Windows compatible software relational database application, which is designed to generate CAPA forms and a log for a International and Quality Management Systems. In addition, QMSCAPA provides a method to flow information into the CAPA log from the Customer Feed-back log, Non-conformance log and findings from external and internal audits.

Summary of QMSCAPA Features and Modules

Action Task List for Corrective Action Teams

Alert Notices from Quality, Environmental, Health & Safety Systems

Audit Planning and Audit Reporting

Configuration Management for assembly and packaging

Customer Feed-back (including complaints and satisfaction)

Customer Satisfaction Survey Designer

Customer Table

Document Control Management

Document Management and Control Tree

Document Text Editor (RTF) for document generation and modifying report text fields

Document Version Control

Electronic approval support for Documents & Records

Employee Initiatives & Opportunity for Improvement

External Audits

FDA Title 21, Sub-Chapter A, Part 11 Compliance

Fault Tree Analysis for Corrective Actions

Five Why Analysis for Corrective Actions

Links from the Document Control Index to Google Docs

Integration with gDocs (plus other web based documentation systems)

Internal Audit Planning & Results

Job Titles, Descriptions, Competency and Training

Journal for Review of Quotes, Contracts and Orders

Key Performance Tracking

Methods for Management Review

Monitoring & Measuring Device Schedules for Calibration and Maintenance

Nonconforming Output Controls

Non-conformance Reports

Performance Dashboard

Personnel Training Records

Process Interactions

Quality and Management System Objectives

Records Control Index Module

Risk Assessment and Management Tools & Reports for Business Continuity, Environmental, Information Security, Quality, Safety and Other Security

Relevant Interested Parties Module

Risk Assessments and Management Controls for support of 'Risk-based thinking'

Risk Mitigation and Treatment Planning

Supplier Evaluations

Supplier Quality Report Cards

Supplier Survey Questionnaires

Training Programs and

Training Schedules

A Corrective Action Request and Preventive Action Request tracking software system is essential for any quality system. It is a regulatory requirement that FDA / global 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, ensures continual improvement.

 

Features in Version 2.23.8:

Alert Notices for Initiatives and Non-conformance Reports

Checklist Designer and Generator

Corrective Action Module

CAPA Graphical Charts

CAPA Search & Query tool for CAPA data analysis

CAPA Task List

Custom CAPA form generator and report builder

Customer Satisfaction Survey & Calculator

Module for logging Corrective Actions to address nonconforming outputs.

Database module for logging Alerts, Initiatives, Messages and Non-conformance for matters related to the Environment, Health, Quality and Safety.

Database module for logging Customer Feed-back

Directory of Management Personnel/Resources

Dashboard for Monitoring Quality

Database module for maintaining a master document index

Database module for recording calibrations and maintenance of monitoring and measuring devices

Database module for recording personnel that are associated with the QMS

Database module for recording personnel training records, includes a method for verifying training effectiveness.

Document Control Index Viewer

Document Manager and RTF Editor

Document Revisions and Approval records made be Locked

Dynamic CAPA Query & Search feature for CAPA analysis

Email Assist for distribution of Customer Feed-back, Non-conformance Reports and Corrective Actions

Export to Excel options

Fault Tree Analysis

Five "Why" Analysis

Graphical Charts for Key Performance Indicators and

Graphical and Digital Charts for Quality Objectives.

Email Assistant for the Windows default email client.

Import from Excel Wizard

Internal Audit Checklist

Interested Parties Journal with expectations, objectives and requirements

Internal Audit Results Log for Management Review

Internal Audit Schedule for One or More Standards/System

Key Performance Indicator (KPI) Reports

Manufacturing & Production Quality Metrics Calculator

Microsoft Outlook TASK links from the QMSCAPA Task Table

Multilevel Multi-level_Security and control.

Multilingual support for Editing Window Field Names

Multilingual support for User-defined Help

On-Time Delivery Calculator

On-time Delivery logs

Optional database for managing external documents

OSHA Hazard Communication Standard for Safety Data Sheets (SDS)

Purchasing Quality Metrics Calculator

Preventive Action (CAPA) Module

Process & Standard Element Interaction Reports

Product Configuration Management

Product Life Cycle Planning and Evaluations

Quality Key Performance Indicators Database

Records Approved may be Locked

Report Builder for End-user Developed Reports

Records Control Index

Report to an RTF output files

Risk Assessment and Mitigation Module

Risk Assessment Reports

Risk Assessment Templates

Safety Data Sheets

Sales Quality Metrics Calculator

Save most reports as an Excel compatible file

Support for electronic signatures

Support for multiple simultaneous users

Supply Chain Management module

Supplier/Vendor Evaluation module

Supplier/Vendor Quality Surveys

Training Programs

Training Schedules

Training Results

Vendor database with approval, status and tier levels

 

The CAPA Fault Tree Analysis window is graphical display of fault tree cause analysis of a single CAPA and may be accessed from the CAPA Browse Table.

Compatible with International Managements Systems:

Many users have reported QMSCAPA to be suitable for International Management Systems based upon the ISO 9001 Standard, AS9003, AS9100, AS9110, AS9120, e-Stewards, IATF 16949, ISO 9001, ISO 13485, ISO 14001, IATF 16949, ISO 17025, ISO 18001, ISO 22000 FSMS, ISO 22716 cGMP, ISO 22301, ISO 27001, ISO 45001, NIST 800-171, R2v3 and TL9000.

PDCA Process Model

PDCA Process Model

Learn what's new and what's planned for QMSCAPA software

 

Computer Requirements:

32 or 64 bit CPU

Windows 8.1, Windows 10, 11 or;

Windows 2012 Server

Windows 2016 Server

Windows 2019 Server

Support for Apple OS devices through Remote Desktop Services

 

For QMSCAPA installations with multiple users, ABCI recommends Windows 2019 Server, or higher with Remote Desktop Services (formerly Terminal Services) for simultaneous multiple Remote Desktop Users.

 

*The current application may be later than this publication.

 

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