21 CFR 117.305 - General Requirements Applying to Records

What it says

Records required by 21 CFR Part 117 must contain the actual values and observations obtained during monitoring and, as appropriate, be accurate, indelible and legible. They must be created at the time the activity is performed and be as detailed as necessary to provide a history of the work. Each record must include the name and location of the plant, the date and time of the activity, the signature or initials of the person performing the activity and, where appropriate, the identity of the product and the production code.

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

What it means in practice

• The standard is actual values and observations, so recording a tick or the word OK in place of the measured value does not meet the requirement.
• Each record has to show who did the work and when, through the date and time and the signature or initials of the person performing the activity.
• Corrections should leave the original entry visible, which fits good data integrity practice for both paper and electronic records.

What FDA inspectors look for

• Whether records show the actual values observed and not only a pass or fail.
• Whether entries are dated, timed and initialed and were made when the activity was performed.
• Whether the correction of errors leaves the original entry legible.

Related regulations