The qmsWrapper Quality System Manual Creator & GAP Report Tool

This video provides an in-depth exploration of qmsWrapper's Quality System Manual Creator and GAP Report Tool, designed specifically for the medical device industry. The presentation highlights the critical importance of regulatory compliance in med tech, emphasizing the stringent requirements from bodies like the FDA and EMA for achieving certifications such as CE mark or FDA 510 K clearance. The core message is that a robust Quality Manual is indispensable for any medical device company, and qmsWrapper offers an interactive, integrated solution to simplify its creation and maintenance, ensuring adherence to standards like ISO 13485:2016 and U.S.QSR (21CFR 820).

The video demonstrates how the qmsWrapper tool streamlines the process of developing a comprehensive Quality Manual. It showcases an intuitive interface where users can navigate through chapters covering different parts of the ISO 13485 standard. The tool allows for customization of paragraphs to fit specific company needs, providing hints, examples, and actionable information during the editing process. A key feature is the ability to mark and filter chapters as "applicable" or "not applicable," tailoring the manual to the company's unique operations. Furthermore, the Quality Manual is seamlessly connected to the company's business processes, allowing users to link predefined or custom-created processes directly within the manual, thereby integrating workflows with quality documentation.

Beyond manual creation, the video introduces the invaluable GAP Report Tool. This feature is designed to proactively identify discrepancies between current company practices and the requirements of compliant standards and the established Quality Manual. It provides a quick overview of items that are in progress, pending, missing, or require further attention within various processes. The video concludes by illustrating the workflow for approval, where the completed Quality Manual is sent through an automatic approval process to the CEO. Once approved, the QMS manager receives a task to review and place the locked, approved version in the QMS vault for future reference, with the capability to output the manual and gap report as a PDF for printing and easy updates.

Key Takeaways:

• Regulatory Imperative in Med Tech: The medical device industry is highly regulated, requiring strict adherence to standards from bodies like the FDA and EMA for market clearance (e.g., CE mark, FDA 510 K). A Quality Manual is a mandatory document for demonstrating compliance.
• Integrated Quality Manual Creation: qmsWrapper offers an interactive tool that helps companies create their Quality Manual, fully integrated with their Quality Management System (QMS) processes and workflows, ensuring alignment with ISO 13485:2016 and U.S.QSR (21CFR 820).
• Structured Manual Navigation and Customization: The tool organizes the Quality Manual into chapters based on ISO 13485, allowing for easy navigation. Users can tailor specific paragraphs to their company's unique needs with guided editing, examples, and actionable information.
• Contextual Filtering for Applicability: Companies can mark and filter chapters as "applicable" or "not applicable," ensuring the generated Quality Manual is precisely relevant to their operations and avoiding unnecessary sections.
• Seamless Process Integration: The Quality Manual is directly linked to the company's business processes. Users can either utilize predefined processes or create custom ones using a process editor and then link them within the manual, ensuring operational procedures align with quality documentation.
• Proactive GAP Analysis: The included GAP Report Tool is crucial for identifying missing reports, incomplete processes, or inconsistencies between current practices and compliant standards before external auditors do. This proactive approach helps prevent compliance issues.
• Comprehensive Compliance Overview: The GAP Report Tool provides a single-glance view of what is in progress, pending, missing, or needs attention across various processes, enabling quick identification of areas requiring improvement.
• Automated Approval Workflow: The system includes an automatic approval workflow, sending the completed Quality Manual to the CEO for approval, streamlining the documentation sign-off process.
• Controlled Document Management: After approval, the QMS manager is automatically tasked to review and place the approved Quality Manual in a secure QMS vault, where it is stored and locked for future reference, ensuring version control and data integrity.
• Flexible Editing and Output: The Quality Manual can be easily edited and updated at any time without needing to create an entirely new document for every change. Users can also output the Quality Manual and GAP Report as PDF files for printing and external sharing.
• Focus on Product-to-Market: By simplifying QMS and compliance documentation, the tool allows medical device companies to prioritize product development and market entry, reducing the administrative burden of regulatory adherence.

Tools/Resources Mentioned:

• qmsWrapper: The primary software platform discussed, offering the Quality System Manual Creator and GAP Report Tool.
• ISO 13485:2016: International standard for quality management systems for medical devices.
• U.S.QSR (21CFR 820): U.S. Quality System Regulation for medical devices, part of the Code of Federal Regulations.

Key Concepts:

• Quality Manual: A document that outlines a company's quality management system, its policies, procedures, and practices, demonstrating adherence to regulatory standards.
• QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• GAP Report: A tool or document used to identify the "gap" between current practices or documentation and required standards or desired states, highlighting areas of non-compliance or inefficiency.
• CE Mark: A certification mark indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
• FDA 510(k) Clearance: A premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.