Automated Control System Audits

Proper functioning of automated control systems is key to producing safe food or pharmaceutical products. Automated control systems can be used to produce electronic records or to control part of all aspects of a stabilization process, or both. IEH staff can evaluate if automated control systems are functioning properly for the selected unit operations, and IEH will evaluate if appropriate validation of automated systems as described in other sections of the brochure has taken place. For FDA food and pharmaceutical products, IEH can determine if electronic record keeping systems and procedures are in compliance with the 21 CFR Part 11 regulation.

IEH can evaluate validation plans, user requirement specifications, functional specifications, design specifications, system build procedures, installation qualification procedures, operational qualification procedures, performance qualification procedures, validation reports, standard operation procedures (SOPs), change control procedures, on-going maintenance and operation procedures, system security measures, and documentation procedures. The proper validation of automated control/record keeping systems will help clients when questions from FDA or USDA/FSIS arise.

After completion of the audit, IEH will issue a detailed report with comments and recommendations and follow up with a telephone call to discuss the findings and recommendations with the client.