21 CFR § 112.165 - What formats are acceptable for the records I keep?

§ 112.165 What formats are acceptable for the records I keep?

You must keep records as:

(a) Original records;

(b) True copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records); or

(c) Electronic records. Records that are established or maintained to satisfy the requirements of this part and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this part, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.