21 CFR 117.315 - Requirements for Record Retention

What it says

Records required by 21 CFR Part 117 must be kept for at least two years after the date they were prepared. Records relating to the general adequacy of the equipment or processes used by a facility, including scientific studies and evaluations, must be kept for at least two years after their use is discontinued. Records may be stored offsite if they can be retrieved and provided onsite within 24 hours of a request for official review, and electronic records are considered onsite if they are accessible from an onsite location.

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

What it means in practice

• The two year clock for most records runs from the date the record was prepared.
• For records about equipment or process adequacy, such as validation studies, the two years start only when the equipment or process is retired, so these records often have to be kept much longer.
• The 24 hour retrieval standard for offsite storage means archive vendors and electronic systems should be tested for how quickly records can actually be produced.

What FDA inspectors look for

• Whether the retention periods in the records procedure match or exceed the requirement for each type of record.
• Whether archived records can be produced within 24 hours of a request.
• Whether validation and process records are kept for as long as the process is in use plus the retention period.

Related regulations