One practical question: where does FDA guidance discuss backup records, and which requirement does it cite?
FDA · Guidance for industry · December 2018
Follow the source
Questions and Answers
December 2018
An FDA guidance document can lead you to the requirements it cites. This example follows the reference to computer systems and backup records.
This is a source-based illustration. The page location was checked manually; it is not a claim of automatic locator completeness across the database.
Step 1 · FDA guidance
An FDA guidance document can lead you to the requirements it cites. This example follows the reference to computer systems and backup records.
Location: Section II · Printed page 2
Read FDA guidanceStep 2 · Cited requirement
Continue to the cited regulation and review the requirement in its own context. The current eCFR text may differ from the edition referenced by a historical guidance.
Location: Paragraph (b)
Read the regulationStep 3 · Original passage
“backup data are exact and complete”The phrase appears in the FDA guidance’s discussion of § 211.68. Open the original publication to read the surrounding discussion.
Location: Section II · Printed page 2 / PDF page 6
Open the source passageThe guidance is dated December 2018. The eCFR link opens the current regulation. Check the edition and applicability for your review.
A reference connection does not establish compliance or an effect on your SOP.