Computer System Assurance Self-Assessment by Administrator | Nov 3, 2023 | 0 comments Welcome to the Computer System Assurance Self-Assessment We appreciate your participation in our Computer System Assurance Self-Assessment. Your insights and feedback are invaluable in helping us ensure the integrity, quality, and regulatory compliance of our computer systems. Before you begin the assessment, here's some essential information: In this assessment, you will be presented with a series of statements regarding various aspects of our Computer System Assurance practices. You are kindly requested to rate each statement If you have any additional comments or remarks regarding the assessment or our Computer System Assurance practices, please feel free to include them. Thank you for your commitment to enhancing our CSA processes. Your participation is crucial in helping us continually improve our system assurance practices and maintain the highest standards of quality and compliance. Let's get started with the assessment. Click "Start" to begin. If you have any questions or encounter any issues, please don't hesitate to reach out to our support team. Thank you for your time and dedication! 1. Process Definition Are the new Computer Software Assurance (CSA) framework and procedures available and implemented? Not Implemented Partially Implemented Implemented None Hint 2. Process Definition Are the Computer System Validation (CSV) / Computer Software Assurance (CSA) SOPs and workflows available and up to date? Yes No None Hint 3. Process Definition Are Electronic Quality Management, Document Management and Test Management system available and implemented? Not Implemented Partially Implemented Implemented None Hint 4. Change Control Is the change control management process implemented and validated? Not Implemented Partially Implemented Implemented None Hint 5. GxP Regulatory Determination Risk Assessment Has a comprehensive risk-based approach (based on new CSA guidelines) been determined and applied to classify the computer software GxP criticality? Not Implemented Partially Implemented Implemented None Hint 6. GxP Regulatory Determination Risk Assessment Are risk assessments regularly reviewed and updated based on business or process changes? Yes No None Hint 7. GxP Regulatory Determination Risk Assessment Are the systems regularly assessed for regulatory compliance and Data Integrity requirements? Yes No None Hint 8. Assurance Activities Are the users assessed and trained on the respective roles properly? Yes No None Hint 9. Assurance Activities Has a comprehensive risk-based approach based on new CSA guidelines are determined and applied for Functional Risk Assessment? Not Implemented Partially Implemented Implemented None Hint 10. Assurance Activities Has an appropriate Assurance Activities (Scripted, Unscripted and Adhoc testing) been determined and implemented based on Functional Risk assessment (FRA)? Not Implemented Partially Implemented Implemented None Hint 11. Assurance Activities Has an approach to establishing the appropriate records for Assurance Activities been determine and implemented? Not Implemented Partially Implemented Implemented None Hint 12. Assurance Activities Is the utilization of Automation tools in the assurance activities identified and implemented? Not Implemented Partially Implemented Implemented None Hint 13. Maintenance Are the procedures for maintaining deviations, non-conformances and Corrective and preventive actions (CAPAs) available and implemented? Not Implemented Partially Implemented Implemented None Hint 14. Maintenance Are the procedures for periodic reviews of GxP systems available and implemented? Not Implemented Partially Implemented Implemented None Hint 15. OVERALL CSA MATURITY LEVEL Additional Comments/Remarks (if any) Thank You for Your Feedback! We truly appreciate your time and effort in completing Computer System Assurance Self-Assessment. Your valuable feedback is essential to help us improve and provide you with a better experience. Your input helps us understand your needs and preferences, allowing us to tailor our services to meet your expectations more effectively. We take your feedback seriously and will use it to make the necessary improvements. Thank you for being a part of our journey towards continuous enhancement and excellence. We look forward to serving you even better in the future. If you have any further comments or suggestions, please don't hesitate to reach out to us. Your opinions matter to us, and we're here to listen. Once again, thank you for your participation and your trust in us. Name Email Business Phone Time's up
