This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
In one of the initial slides, you mentioned that documents attached to emails do not fall under 21 CFR Part 11. Could you elaborate a bit more?
The exception appears in Subpart A – General Provisions, Section 11.1 Scope, letter (b): However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
We understand this to be saying that Part 11 does not apply to any paper records, even if they are sent electronically (e.g., a scan of a paper record that is transmitted by email or fax). Now, if a file attached to an email were, say, a PDF report generated out of a 21 CFR Part 11 system, as opposed to a scanned piece of paper, the above exception would not apply.