FDA 21 CFR Part 11

21 CFR Part 11, standard from US Food & Drug Administration
Applying to pharmaceutical industry, medical operations and cosmetics, it specifies the way documents and electronic data should be correctly used in order to certify the reliability and safety of a system. The standard was set up to minimize risks related to electronic processing of data.

Key-rules are precisely defined in terms of system validation and safety, audit trail, operational control, documentation management, electronic signature and education.
 
CALYS 75 / 100 / 150 compliance:
  • Audit trails trace all actions and events during a qualification
  • Access rights are managed by the Administrator
  • Access is authorized through password and user ID given by the Administrator
  • All records are protected in a native format and shall not be corrupted
  • Electronic signature is required for every action into the system
  • Training is provided by the manufacturer