More and more, today's manufacturers are challenged with complying with the increasing regulation of their processes. The importance of ensuring that only authorized persons are able to modify the process, and that every modification be reliably recorded in a way that protects it against manipulation, cannot be understated. Before any product can be sold, a production plant and/or process must be validated and authorized by inspectors to make certain that the plant complies in every way.

Previously, all documents and signatures had to be committed to paper; today, after fulfilling specific prerequisites, data can be electronically collected and stored to fulfill the conditions required for validation. The U.S. Food and Drug Administration (FDA) define these prerequisites in the FDA 21 CFR Part 11 regulation.

The Siemens HMI SCADA software, SIMATIC WinCC supports compliance with these regulations for electronic records and signatures. Quickly and easily implemented, this system optimizes the manufacturing process and improves quality.

FDA 21 CFR Part 11 describes the use of electronic records and electronic signatures. It defines time-stamped data via access control, electronic signature, audit trail, change control and archiving.

The SIMATIC WinCC V6 SCADA system in combination with the Audit and SIMATIC Logon options makes your application "ready for validation." This benefits not only manufacturers, but also system integrators and the machine builders. Full compliance with FDA 21 CFR Part 11 is achieved, along with additional administrative and procedural controls.

Today, process optimization and simultaneous compliance with FDA regulations is the main requirement in the pharmaceutical industry, with increasing presence in other industries. The use of electronic records and electronic signatures to FDA 21 CFR Part 11 serves this objective.