My question is regarding SPL submissions via EGS and other software used to submit electronic files to the FDA.
Would making an SPL then sending it through the portal require any validation under Part 11?
Additionally if we have software, for example, that we use to send CBE-30s to the FDA would that require validation?
In my opinion based on Part 11 Section 11.1 (b) yes it would.
“This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.”
Any insight into this would be greatly appreciated.