The FDA has answered this question explicitly and
implicitly in two different areas. First, they talk about data
retention requirements for pharmaceutical products, and the
requirement is to maintain pharmaceutical manufacturing
records for seven years after the expiration of the last
manufactured lot of a particular pharmaceutical product. So,
if after seven years production of a drug product is halted,
and the product has an expiry that’s 12 or 18 months out, then
seven years after that expiration date, it is acceptable to delete
data. Second, CFR Part 11 specifies that audit trails need to deal
with three things: they need to deal with creation of regulated
records, modification of regulated records, and the deletion of
records. However, pre-Part 11 in the mid-90s, the FDA found
that many companies, in their analytical laboratories, were
deciding that the final analytical report was the regulated
record, and companies were deleting the raw data.
