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Note however that there's a valid question, not substantively answered yet by the FDA as far as I know (and I've asked them directly), as to whether some form of electronic capture or recording of a signed document in a 21CFR Part 11 context may become a valid record in and of itself, including a record of the signature, sufficient to replace the original document for regulatory purposes so that it would be permissible to destroy the original document.
That for instance might consist of a record-batch scanning or photographing procedure, with a signature per batch by the scanning individual indicating that they had performed the scanning and that the records they had scanned were original, apparently unmodified and were physically signed and dated.
We've been told that such a process isn't acceptable at this time, but that it's being considered.
Such a process of course would be substantially different from transcription of data into a spreadsheet, which inherently does not capture the signature involved or allow any inspection of the nature of the data record.
That for instance might consist of a record-batch scanning or photographing procedure, with a signature per batch by the scanning individual indicating that they had performed the scanning and that the records they had scanned were original, apparently unmodified and were physically signed and dated.
We've been told that such a process isn't acceptable at this time, but that it's being considered.
Such a process of course would be substantially different from transcription of data into a spreadsheet, which inherently does not capture the signature involved or allow any inspection of the nature of the data record.