---
kind: "section"
citation: "21 C.F.R. § 121.305"
title: "21"
number: "121.305"
heading: "General requirements applying to records."
url: "https://uscodex.org/cfr/21/121.305"
---

# §121.305. General requirements applying to records.


Records must:

- (a) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records;
- (b) Contain the actual values and observations obtained during food defense monitoring;
- (c) Be accurate, indelible, and legible;
- (d) Be created concurrently with performance of the activity documented;
- (e) Be as detailed as necessary to provide history of work performed; and
- (f) **Include—**
  - (1) Information adequate to identify the facility (e.g., the name, and when necessary, the location of the facility);
  - (2) The date and, when appropriate, the time of the activity documented;
  - (3) The signature or initials of the person performing the activity; and
  - (4) Where appropriate, the identity of the product and the lot code, if any.
- (g) 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)](/cfr/21/11.3.md?p=b-6) of this chapter are exempt from the requirements of [part 11](/cfr/21/part11.md) 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](/cfr/21/part11.md) of this chapter.

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 350g, 350(i), 371, 374.

### Source

Source: 81 FR 34219, May 27, 2016, unless otherwise noted.