About This Guide

AVEVA prides itself in helping customers reduce the cost and time of application development. In going a step further, AVEVA wants to provide customers from Food and Drug Administration (FDA) audited industries with a set of best practices in regards to the 21 CFR Part 11 requirements.

This AVEVA Batch Management 21 CFR Part 11 Deployment Guide offers information on AVEVA Batch Management features relevant to the 21 CFR Part 11 requirements of the U.S. Food and Drug Administration (FDA).

While not directly subject to regulation under 21 CFR Part 11, the AVEVA Batch Management product incorporates features and functionality designed to facilitate the development of applications for use in FDA-regulated industries. Accordingly, AVEVA has developed this document to provide customers with a set of "best practices" in regards to the 21 CFR Part 11 requirements.

Best practices suggested in this deployment guide, in conjunction with properly designed and implemented external procedural controls, should reduce cost of development, validation, and re-qualification of applications.

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 a AVEVA endorsed System 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 DBMS and using the administrative tools provided with the Microsoft Windows Server operating system.

For more information on Microsoft SQL Server or the Microsoft Windows operating system, please refer to the relevant Microsoft user documentation.

AVEVA Batch Management uses Microsoft Windows Server Operating Systems and can be configured so that it manages and monitors processes used in FDA-regulated industries. AVEVA Batch Management Historian uses Microsoft SQL Server as its database management system/ DBMS

AVEVA Batch Management is a flexible batch management software designed to model and automate batch processes. It is typically used in combination with AVEVA System Platform, InTouch, AVEVA Historian, the AVEVA Alarm System and procedural controls to implement systems that comply with the FDA's 21 CFR Part 11 regulation.

A separate “System Platform Deployment Guide (Section 21_CFR_Part11) contains recommendations for using AVEVA System Platform, InTouch, AVEVA Historian and the AVEVA Alarm System in FDA-regulated industries. You can also refer to online documentation.

Important: This deployment guide is designed for closed systems only.

Note: Closed systems are defined as systems where access is controlled by the people responsible for the content of the electronic records. This document does not address Open Systems.

The AVEVA Batch Management CFR 21 Part 11 Deployment Guide describes the 21 CRF Part 11 Regulation in section 2. The regulation can be met using a combination of procedural controls that are described in section 3 and technological controls that are described in section 4.