21 CFR 117.305
§ 117.305 General requirements applying to records.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 117.305, § 117.305 General requirements applying to records, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84428
- Permanent ID
ys:prov:84428@1- SHA-256
c5d96b9ef3ea9dc9e94030278d54cd82c310e9ffc104545a6187bed31d5ae2aa
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
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 monitoring and, as appropriate, during verification activities;
(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 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.
(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) 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.