MasterControl Whiteboard Quality Management System Overview

This video provides an in-depth exploration of MasterControl's Quality Management System (QMS), showcasing how it offers a closed-loop, connected platform to manage the entire product lifecycle in regulated industries. The presentation begins by highlighting the inefficiencies and errors inherent in traditional multi-system approaches to bringing a product to market. It then positions MasterControl as a unified solution that connects every phase, from initial project planning to regulatory approval, manufacturing, supplier management, and change control, thereby eliminating the need for disparate systems and paper-based processes.

The demonstration walks through the core functionalities of the MasterControl QMS, starting with its project management capabilities. Users can set up projects with specific tasks, monitor progress, track dependencies, and view task durations and assignments. A key feature is the collaboration workspace, which enables team members to share, edit, and approve documents seamlessly, ensuring that the project plan is automatically updated upon document completion and submission. This integrated approach aims to foster better teamwork and maintain real-time visibility across all project activities.

A significant portion of the video focuses on the system's robust regulatory management features, particularly for the pharmaceutical industry. It illustrates how MasterControl can structure and manage common technical documents (CTD), enabling easy monitoring of documentation approval and population into appropriate folders. When it's time for submission, the system can export all necessary documents in a format suitable for publishing tools, ready for submission to regulatory bodies like the FDA. Furthermore, the QMS facilitates comprehensive supplier documentation management, allowing internal managers to view all supplier-related information, corrective actions, and quality events, with the option to grant controlled access to suppliers themselves via a secure link.

Beyond documentation, the video details MasterControl's capabilities in operational quality and compliance. It demonstrates how the system manages employee training and certification, showing how manufacturing operators can access pending training tasks, study necessary procedures and materials, complete exams (multiple choice, true/false, etc.), and provide electronic signatures to create a compliant training record. The QMS also handles quality events, such as non-conforming material reports (NCMRs), allowing users to document occurrences, route them for review, and initiate appropriate actions. An integrated analytics dashboard provides quality managers with at-a-glance insights into collected events, enabling tracking, trending, and drill-down analysis into specific failure codes. The demonstration concludes by showcasing supplier audit management and the critical process of change control, which can be initiated from a CAPA (Corrective and Preventive Action) to propose, assess, implement, and verify changes, thus rounding out the comprehensive quality story.

Key Takeaways:

• Unified Quality Management System: MasterControl offers a single, connected QMS that integrates all phases of the product lifecycle, from project planning to manufacturing and regulatory approval, eliminating the inefficiencies and errors associated with multiple disparate systems.
• Streamlined Project Management: The system includes a projects module for setting up tasks, monitoring progress, tracking dependencies, and managing task durations and assignments, providing clear visibility into project status.
• Enhanced Collaboration: A dedicated collaboration workspace allows team members to securely share, edit, and approve documents, ensuring that project plans are automatically updated upon document completion and approval.
• Robust Regulatory Document Management: Specifically tailored for industries like pharmaceuticals, the QMS manages common technical documents (CTD) structures, facilitates monitoring of documentation approval, and prepares documents for submission to regulatory bodies like the FDA.
• Comprehensive Supplier Management: The system centralizes supplier documentation, quality events, and corrective actions, allowing internal managers to oversee supplier performance and providing controlled access to suppliers for relevant information.
• Compliant Training Management: MasterControl enables the management of employee training and certification, including access to procedures, study materials, exams, and the use of electronic signatures to create auditable training records for GxP compliance.
• Efficient Quality Event Handling: The QMS provides tools for documenting and managing various quality events, such as non-conforming material reports (NCMRs), routing them for appropriate review and action, and ensuring a closed-loop process.
• Data-Driven Quality Analytics: An integrated analytics dashboard offers quality managers real-time insights through charts and reports, allowing them to track and trend quality events, identify patterns, and drill down into specific failure codes for root cause analysis.
• Structured Supplier Audits: The system supports the entire supplier audit process, from task assignment for auditors to documenting observations, collecting supporting information, and generating formatted audit reports.
• Controlled Change Management: MasterControl facilitates a structured change control process, often initiated from a CAPA, allowing users to propose, assess, route for group review, implement, and verify changes, ensuring all modifications are documented and compliant.
• Accelerated Compliance and Time-to-Market: By connecting all quality processes and ensuring electronic record-keeping and regulatory adherence, the QMS helps companies improve overall quality and accelerate the time it takes to bring products to market.
• Electronic Signatures for Compliance: The system leverages electronic signatures for critical actions like training completion and document approvals, ensuring compliance with regulations like 21 CFR Part 11.

Tools/Resources Mentioned:

• MasterControl: The Quality Management System (QMS) itself, which is the subject of the overview.

Key Concepts:

• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Common Technical Document (CTD): A set of specifications for a dossier for the registration of medicines, designed to be used across Europe, Japan, and the United States.
• Non-Conforming Material Report (NCMR): A document used to record and track materials or products that do not meet specified quality standards.
• Corrective and Preventive Action (CAPA): A system for investigating and correcting identified nonconformities (corrective action) and preventing potential nonconformities (preventive action).
• Supplier Corrective Action Report (SCAR): A formal request to a supplier to investigate and correct a nonconformity related to their products or services.
• Change Control: A formal process used to manage changes to a product, system, or process, ensuring they are documented, assessed, approved, and verified.
• Electronic Signature: A method of signing a document or record electronically, often used in regulated industries to ensure authenticity and compliance with regulations like 21 CFR Part 11.
• FDA Submission: The process of submitting documentation to the U.S. Food and Drug Administration for approval of new drugs, medical devices, or other regulated products.