CSA Questionnaire Submit Your Details Full Name* Organization Name* Email Address* 1. What is your organization’s primary goal of Computer System Validation (CSV)? To provide documented evidence to auditors To detect as many software errors as possible before go-live A combination of both but dominated by securing evidence for auditors For testing and detecting as many software errors as possible – documentation is an afterthought. 2. Does your organization follow a risk based Computer System Validation approach for non-product GxP computerized systems? Yes No We generate a functional risk assessment – but it is primarily used as a documentation exercise. Our testing is not commensurate with risk levels. 3. If yes to previous question, is the risk approach based on FMEA (Failure Mode Effect Analysis) methodology? Yes No 4. Does it feel like your organization classifies most requirements as High risk? Yes No 5. Do you currently write click level, detailed test steps for requirements of all risk levels (High/Medium/Low)? Yes No We write click level instructions for High and Medium risk but now low risk 6. Do you currently write click level, detailed test steps for all types of test cases (IQ/OQ/PQ)? Yes No Click level for IQ/OQ but not PQ 7. Do you currently test Out of box functional requirements for commercially off the shelf, industry standard systems (e.g. SAP, Salesforce, Veeva, PLM, ALM, MES)? Yes No 8. Do you currently encounter a lot of test script and test execution errors? Yes – most defects during validation are documentation related defects No – most defects we encounter are system errors It’s a 50-50 mix 9. Do you continue to encounter bugs in your systems post go-live? Yes No 10. Are Systems categorized by Risk Level (i.e. into High / Medium / Low risk systems)? Yes No 11. Is CSV life-cycle documentation commensurate with the system’s Risk Level? Yes No 12. Does your CSV SOP include guidance for validating Cloud based SaaS systems? Yes No 13. Would You Like a complimentary assessment with one of our Subject Matter Experts? Yes No Submit Now Talk to our expert