【正文】 ? Detailed “As Is” of current processes, anization and systems ? Visioning session for “tobe” concepts ? System Configuration Design ? Installation of Development Environment ? Configure Prototype 1 ? Project Team Workshop1 ? Configure Prototype 2 Requirements / Configuration Design Validation / SOPs / Training Add additional Projects / enhance projects Prototyping / Finalize Configuration / Documentation ? Support application ? Enhance configuration ? Add additional project areas to support additional needs ? PQ ? Leverage Migrator for reduced validation ? Roll out phase Project Phases Post Release ? Install Production ? Execute and approve IQ ? Execute and approve OQ ? Execute and approve PQ ? Complete validation protocol ? Create Training Materials ? Revise SOPs ? Train Super Users ? Train Users ? Train Help Desk ? Roll out phase 23 weeks 48 weeks 68 weeks 4–6 weeks per project Go Live! Implementation Schedule 36 Conclusion Conclusion (cont.) ? QMS enpasses the overall process related to events / observations from multiple sources, as well as their investigations, and resolutions ? A “best practices” QMS system requires a single, scalable system, which uses a holistic approach ? Implementing a global QMS system may require your anization to change how it defines CAPA as well as it how it conducts the CAPA process ? Implementing a system can be successfully acplished by using established software, a harmonized approach, and an anized project structure 38 Q A 39 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH 。Implementing a Holistic Approach to your Quality Management System Steven R. Cagle . of Marketing Product Development Sparta Systems, Inc. Agenda ? Session Objectives ? Quality Management System Overview ? Traditional Challenges ? Redefining CAPA ? Implementing a Quality Management Software Solution ? Conclusion ? QA 2 Session Objective Discuss critical ponents of an effective Quality Management System (QMS), challenges with current systems, and solutions to overe these challenges by implementing a holistic Quality Management Software solution. 3 General Introduction Defining CAPA – ISO 13485:2023 ? Corrective Action – Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer plaints) b) determining the cause of nonconformities c) evaluating the need for action to ensure that nonconformities to not recur d) determining and implementing action needed, including, if appropriate, updating documentation e) recording of the results of any investigation and of action taken, and f) reviewing the corrective action taken and its effectiveness 5 Defining CAPA – ISO 13485:2023 ? Preventive action – The anization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. ? It is also determine potential nonconformities and their causes a) evaluating the need for action to prevent occurrence of nonconformities b) determining and implementing action needed c) recording of the results of any investigations and of action taken, and d) reviewing preventive action taken and its effectiveness 6 Quality Regulation 21 CFR ? . Food and Drug Administration’s regulation governing medical device manufacturers quality systems: (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action