---
kind: "section"
citation: "21 C.F.R. § 507.202"
title: "21"
number: "507.202"
heading: "General requirements applying to records."
url: "https://uscodex.org/cfr/21/507.202"
---

# §507.202. General requirements applying to records.

- (a) **Records must—**
  - (1) 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;
  - (2) Contain the actual values and observations obtained during monitoring and as appropriate, during verification activities;
  - (3) Be accurate, indelible, and legible;
  - (4) Be created concurrently with performance of the activity documented; and
  - (5) **Be as detailed as necessary to provide history of work performed.**
- (b) All records must include:
  - (1) Information adequate to identify the plant or facility (e.g., the name, and when necessary, the location of the plant or 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.
- (c) 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, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56337, Sept. 17, 2015, unless otherwise noted.