FDA releases Part11 Guidance on electronic copies

On Nov 12, 2002 FDA released its 5th draft Part 11 guidance “Electronic Copies of Electronic Records”. The date in the document itself is August 2002. This draft is at the link provided.
It addressed content, format, and integrity requirements for provision of records in electronic form to FDA.It:
– allows that electronic copies do not need to be in the same file format as the original record.
– identifies the need to validate the process for making electronic copies if the file format differs from the original.
– asks that hyperlinked records be included in the copy to prevent problems with obsolete links.
– asks for database queries to be included in the copies
– asks that there be an authentication value in the copy to allow detection of corruption such as a digitial signature message digest or hash value.
– states that FDA will post on their website file formats and media that they will accept.

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