I have now a more precise request?.
Is there a document which shows that SPSS meets the FDA CFR 21 part 11 requirements?
This is an excerpt from a FDA document about the scope of application of CFR 21 part 11:
"Part 11 applies to records in electronic form that are created,26 modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules."
Does anybody have an answer to this question?