Simply put, Part 11 applies to your site if you’re relying on electronic records or electronic signatures to meet an FDA requirement. Additionally, you can’t outsource your regulatory compliance obligations, so you’re still on the hook. You’re still the one that has to answer to the FDA about whether your data is reliable. So, that means that you need to take due diligence and properly vet any potential vendor and ensure they can produce documentation of validation and Part 11 compliance.
