New
DPDP Act compliance check for companies
, core duties apply from 13 May 2027
Know more
Justis AI
Product
Solutions
Use cases
Resources
Pricing
Sign In
Book Now
US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 11 — ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart B — Electronic Records
Federal (United States) · Regulations
Subpart B — Electronic Records
4 sections
4 sections
21 C.F.R. § 11.10
Controls for closed systems.
21 C.F.R. § 11.30
Controls for open systems.
21 C.F.R. § 11.50
Signature manifestations.
21 C.F.R. § 11.70
Signature/record linking.
Subpart B — Electronic Records | Federal (United States) Regulations | Justis AI