21 CFR 117 Subpart F - Requirements Applying to Records That Must Be Established and Maintained

What it says

Subpart F sets general rules for the records that 21 CFR Part 117 requires. Records must be accurate, legible, created when the activity is performed and detailed enough to show the work done. They must show the plant name and location, the date and time, the signature or initials of the person performing the activity and, where appropriate, the product identity and production code. The subpart also covers record retention, offsite storage, official review, public disclosure, use of existing records and written assurances. The food safety plan itself must be signed and dated upon initial completion and upon any modification.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Records are created when the activity is performed, so completing monitoring records at the end of a shift or week from memory does not meet the requirement.
• Existing records kept for other purposes can be used if they contain the required information, which can reduce duplication.
• Records must be kept for the periods the rule sets and be available for official review, which affects both paper and electronic record systems.

What FDA inspectors look for

• Whether records are complete, legible, concurrent, and signed or initialed and dated.
• Whether records can be produced promptly, including offsite and electronic records.
• Whether the food safety plan carries the required signature and date, including after changes.

Related regulations