Does Part 11 apply if we’re keeping both electronic AND paper copies (i.e. wet ink copies are scanned and saved to our shared drive)?

Simply put, Part 11 applies to your site if you’re relying on electronic records or electronic signatures to meet an FDA requirement. The FDA’s draft guidance on 21 CFR Part 11 (Part 11) indicates that if “regulated entity intends to use an electronic copy in place of the paper source data (i.e., intends to destroy the paper source data), then part 11 regulations apply to the electronic system used to create the copy (see §§ 11.10 and 11.30)).