Electronic records

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

Validation of systems to assist with accuracy,reliability, consistent intended performance, and the ability to discern invalid or altered records.

The system validation is a unique process and lies with the customer.

Rockwell Automation can provide validation services for any validation activity performed during the specific integration of the system.

The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding theability of the agency to perform such review and copying of the electronic records.

FactoryTalk Optix Studio can store data records for alarms, audits, and process data into an external database. Alternatively, data records can be stored into an internal (embedded) database, but consideration should be given as to database limitations.

For enhanced detectability, alarming and logic can be implemented to prevent the user from entering data in the event the network connection from FactoryTalk Optix Studio to the database is lost.