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    Since this is a medical app, one place worth looking under the third point is what is the scope of release validation. Are the SQL queries in the DB considered part of your release validation process, or is this a mechanism to enable logic changes in the field to bypass that by classing them as 'configuration' Commented Jul 28, 2024 at 18:18
  • If this is medical software, you also need to consider foreseeable error/risk. So classifying the SQL queries as "configuration" might not get you out of trouble. There likely needs to be some form of process around making any changes to this SQL, since errors could have catastrophic consequences. Commented Jul 29, 2024 at 8:46
  • @JonasH ideally yes. In practice, configuration is often significantly lighter weight approval since it only needs to work for one site, and if done by the site themselves often hits loopholes in regulation. Commented Jul 29, 2024 at 9:46
  • For example, there are no FDA regs around end user changes made to config in violation of documentation. Commented Jul 29, 2024 at 9:47