It is difficult to give specific advice because it depends on the regulated activities that you undertake and your planned use of the software. In general, a documented process for assessing and evaluating applications is a good idea. You can develop a worksheet or set of questions to evaluate the applicability and need for validation/part 11 compliance and document that assessment to provide during an audit. Some questions might include:
- Does the application store records electronically?
- Does it include electronic signatures?
- What records are being stored in the application?
- Will the application be the source for those records?
- Are the records considered required documentation under another FDA regulation?
- Are the studies being conducted and documented in the application under an IND or IDE?
