Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become clear that the agency is quite clear in what it expects from companies when it comes to the kind of records they need to keep and how long they should hold onto them.“The regulations are specific about record retention,” notes Keith Benze, a consultant and compliance expert with SEC Associates and a co-author of The ‘New’ Part 11 and Drug Development: A Q&A Reference Guide (Barnett International, 2004). The FDA focuses on maintaining records for a certain period of time after an event. “For example, one year past the expiration of date of drug products,” Benze adds.

In other cases, that period is usually a year or two after the last distribution of the product or approval for the IND.  For example, Part 11’s section 820.140 states, "All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer."

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