Electronic Records - Subpart B

Controls for Closed Systems - 11.10

21 CFR Part 11:

“Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:”

Companies need to define and execute a system with components (e.g. SOPs, processes, tools) that will ensure the closed system controls are properly established and maintained. Periodic verification, or auditing, of the controls should be performed to maintain the integrity of the controls, once established.

Validation - 11.10 (a)

21 CFR Part 11:

“(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”