Your records do not have to be in electronic format.
Records that are established or maintained for the Sanitary Transportation rule that meet the definition of electronic records in 21 CFR 11.3(b)(6) are exempt from the requirements of 21 CFR Part 11. However, records that satisfy the requirements of this rule, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11. (21 CFR 1.912(h))
