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

Regulations last checked for updates: May 16, 2024

Title 21 - Food and Drugs last revised: May 06, 2024

View all text of Subpart M [§ 1.600 - § 1.725]

§ 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.

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; 42 U.S.C. 216,241,243,262,264,271

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

cite as: 21 CFR 1.694