QMS-4-SME - Quality Management System / Non-Compliance & CAPA Management

This video provides an in-depth exploration of GxpManager's QMS-4-SME application, a software-as-a-service (SaaS) low-code platform designed for quality management in regulated companies. The primary focus is on demonstrating the platform's capabilities for handling non-compliance (deviations) and corrective and preventive actions (CAPA) workflows. The presenter meticulously walks through the entire lifecycle of a non-compliance event, from its initial declaration and analysis to the implementation of immediate actions, the creation and approval of CAPA plans, their execution, and ultimate closure, emphasizing the system's auditability and customization features.

The presentation highlights the GxpManager platform's user interface, which supports multi-factor authentication, single sign-on, and multiple languages, allowing users to select their environment and application. A key aspect is the customizable dashboard, featuring analytics and a pending list for assigned workflows and actions. The core of the demonstration revolves around the structured workflow for non-compliance, illustrating how different roles (initiator, Quality Assurance, action owner) interact with the system. This includes defining criticality, conducting root cause analysis using methods like 5M or QQOQCP (Who, What, Where, When, How, Why), and linking related actions.

Throughout the video, the speaker emphasizes the system's adherence to regulatory requirements, such as the ability to generate auditable reports in PDF or Microsoft Word, export data to Excel, and maintain electronic signatures for all approvals. The platform's flexibility is repeatedly stressed, with features like customizable forms, workflows, mandatory fields, and data display options. The comprehensive demonstration of linking immediate actions and CAPAs directly to the non-compliance record showcases an integrated approach to quality event management, ensuring traceability and accountability from discovery to resolution.

Key Takeaways:

• Integrated QMS Platform: GxpManager's QMS-4-SME is presented as a comprehensive, auditable, and customizable SaaS low-code application platform for managing quality events in regulated environments, accessible via any modern browser.
• Non-Compliance and CAPA Management: The core functionality demonstrated is the end-to-end management of non-compliance records and associated corrective and preventive actions (CAPA), crucial for maintaining quality and regulatory adherence.
• Customizable Workflows and Roles: The system supports fully customizable workflows with defined steps and roles (e.g., initiator, Quality Assurance, action owner), ensuring that only authorized personnel can perform specific actions at each stage.
• Data Integrity and Auditability: Features like mandatory fields, electronic signatures, version control, and the ability to publish records to PDF or Microsoft Word formats ensure data integrity and facilitate regulatory audits.
• Advanced Data Management: Users can leverage advanced search, filtering, and column customization options to personalize their view of data sets, making it easier to navigate and analyze quality records. Data can also be exported to Excel for further analysis.
• Integrated Analytics: The platform includes built-in analytics features, allowing users to create customizable graphs and dashboards from any data within the system, providing quick insights into quality trends and performance.
• Root Cause Analysis Tools: The system integrates tools for conducting root cause analysis, offering methods such as the 5M (Man, Machine, Material, Method, Measurement, Environment) or QQOQCP (Quoi, Qui, Où, Quand, Comment, Pourquoi - What, Who, Where, When, How, Why) to identify underlying issues.
• Action Linking and Traceability: Immediate actions and CAPA plans can be directly created and linked to specific non-compliance records, ensuring a clear audit trail and comprehensive management of all follow-up activities.
• Notification System: Assigned persons receive email notifications to review and act on pending workflows or records, streamlining communication and ensuring timely action within the quality process.
• Regulatory Compliance Focus: The platform is designed with regulated companies in mind, emphasizing features that support GxP requirements, audit trails, and the management of quality processes critical for industries like pharmaceutical and life sciences.
• Efficiency Monitoring: The system allows for efficiency monitoring of CAPAs, enabling organizations to track the effectiveness of their corrective and preventive measures post-implementation.

Tools/Resources Mentioned:

• GxpManager (QMS-4-SME application): The primary software platform demonstrated.
• Microsoft Word: For publishing records.
• Microsoft Excel: For exporting data.
• PDF: For publishing records.

Key Concepts:

• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Non-Compliance (NC) / Deviation: A failure to meet a specified requirement, procedure, or standard, often an incident or deviation from an expected outcome.
• Corrective and Preventive Action (CAPA): A system for investigating and correcting non-conformances (corrective actions) and preventing potential non-conformances (preventive actions).
• GxP: A general term for "Good x Practice" quality guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) applicable to life sciences industries.
• 5M Method: A root cause analysis technique that categorizes potential causes into five main categories: Manpower, Methods, Machines, Materials, and Measurement (sometimes including Environment).
• QQOQCP (Quoi, Qui, Où, Quand, Comment, Pourquoi): A French acronym for a systematic questioning method, equivalent to the 5W1H (What, Who, Where, When, How, Why) used for problem-solving and root cause analysis.
• Electronic Signature: A method of signing a document or record digitally, often with cryptographic security, to ensure authenticity and integrity, particularly important in regulated industries (e.g., 21 CFR Part 11).

Examples/Case Studies:

• Non-Compliance Scenario: A "procedure not respected" is used as a specific example of a non-compliance event.
• Criticality Justification: An example of justifying a "major criticality" due to an "ISO 27001 issue."
• Immediate Action: "Best practices were reminded to the operator" is cited as an immediate action taken to address a non-compliance.
• Root Cause Specification: A non-compliance stemming from a "method" root cause, specifically "non-respect of the procedure because it is too complex for the operations."