About this guide

This 21 CFR Part 11 Deployment Guide provides information about features relevant to the 21 CFR Part 11 requirements of the U.S. Food and Drug Administration (FDA) for the following products:

• AVEVA™ System Platform

• AVEVA™ Application Server

• AVEVA™ Operations Management Interface (OMI)

• AVEVA™ InTouch HMI

• AVEVA™ Historian

This document helps customers reduce the cost and time of application development. In going a step further, it provides customers from Food and Drug Administration (FDA) audited industries with a set of best practices in regards to the 21 CFR Part 11 requirements.

While not directly subject to regulation under 21 CFR Part 11, System Platform, InTouch HMI, AVEVA OMI, and Historian products incorporate features and functionality designed to facilitate the development of applications for use in FDA-regulated industries. Accordingly, this document to provides customers with a set of "best practices" in regards to certain products and the 21 CFR Part 11 requirements.

Note: The methods described in this document represent general guidance and may require adaptation or modification depending on the needs of your specific system implementation. For optimum results, before applying the advice contained in this guide, consult our systems integrator.

Auditing and security functions are tightly integrated with Microsoft products, and working knowledge of both Microsoft SQL Server and the Microsoft Windows operating system is required. It is assumed that you are familiar with administering a Microsoft SQL Server and using the administrative tools provided with the Microsoft Windows Server or Advanced Server operating system.

For more information on Microsoft SQL Server or the Microsoft Windows operating system, see your Microsoft documentation.

System Platform, InTouch HMI, AVEVA OMI, and Historian are AVEVA products for human-machine interface (HMI) software plus a plant historian. They are based on Microsoft Windows and can be used to control and monitor processes in FDA-audited industries. Historian is closely linked to Microsoft SQL Server. System Platform, InTouch, Historian, and procedural controls can be used to implement systems that comply with the FDA's 21 CFR Part 11 regulation.

This deployment guide is designed for closed systems. Closed systems are defined as systems where access is controlled by the people responsible for the content of the electronic records. Open systems are not addressed in this document.