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21 CFR § 1.694 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?

---
identifier: "/us/cfr/t21/s1.694"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.694 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.694"
section_name: "Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---

# 1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?

Records that are established or maintained to satisfy the requirements of this subpart 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 subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.