Controls for closed systems—11​.10

"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. standard operating procedures, 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.