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Beauty by Grace Group

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Vissarion Uvarov
Vissarion Uvarov

Intouch Wonderware Software 9.0

The final phase of Lifecycle Support covers product releases in the mature software life phase. The Mature Support phase follows the 5 years of coverage provided by Mainstream and Extended phases by offering on-going technical assistance to customers maintaining installed product. Mature Support includes:

Intouch Wonderware Software 9.0

Wonderware enforces the use of its products with a software license. After you install a Wonderware product, you must install a single license file, ARCHESTRA.LIC, which contains your customer information, product data, and software features. Until you apply your Wonderware license, you can run the InTouch HMI only in demonstration mode.

The DXF File Viewer allows users to view Autocad Release 12 and older DXF files (only these versions) within InTouch. This software has been designed for the special needs of the MMI environment, such as bulletproofing and friendly multitasking. Since DXF files are loaded from disk at runtime, the viewer displays the very latest drawings, which may have been modified since the InTouch application was created. User can zoom in and zoom out or scroll the drawing in any direction.

This software is designed for just viewing DXF files within WindowViewer. If you are interested in importing DXF files from into your InTouch application for animation and editing, then you may want to purchase the Silent Partner Wizard Library 2.0 (#41237103).

The PLC Data Monitor is a diagnostic and troubleshooting tool which can monitor and change data registers in a PLC. This program can be used to test communication between your DDE server and your PLC, without actually running your MMI software or PLC programming software. Setpoints and data in the PLC can be changed without creating tags in your MMI software. User can type in any address in the PLC and view or modify its contents. The PLC Data Monitor can also be used to help debug your InTouch application by allowing you to view or change the value of any tag "on-the-fly" without creating animation links. Requires a DDE server for communication to your PLC. (Visit for a large selection of DDE servers).

UpgradeThis issue has been addressed in Wonderware InTouch version 9 and later. Wonderware administrators with active support contracts who do not want to upgrade can get an updated version of Wonderware 8.0. Wonderware Tech Alert 98 contains information about obtaining fixed software. Wonderware administrators can also contact Wonderware for more information about obtaining updates.Please see the Systems Affected section below for information about other vendors.

The versiondog system supports the management of AVEVA (formerly Wonderware) InTouch HMI visualisation software and allows for the cyclical monitoring of devices using AVEVA (formerly Wonderware) InTouch

4 1. Before You Begin 1.1 About this Guide Wonderware prides itself in helping customers reduce the cost and time of application development. In going a step further, Wonderware 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 21 CFR Part 11 Deployment Guide for System Platform 3.1, InTouch 10.1, and Historian 9.0 offers information on System Platform, InTouch, and Wonderware Historian 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, Wonderware System Platform, InTouch, and Wonderware Historian products incorporate features and functionality designed to facilitate the development of applications for use in FDA regulated industries. Accordingly, Wonderware has developed this document to provide customers with a set of best practices in regards to certain Wonderware products and 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. However, please note that 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 Wonderware endorsed 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 3.1, InTouch 10.1 and Historian 9.0 are Wonderware s products for human-machine interface (HMI) software and a plant historian. They are based on Microsoft Windows and can be used to control and monitor processes in FDA-audited industries. Wonderware 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. Readers should note 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 the scope of this document. 1.2 Wonderware References & Documentation A PDF file for each of the following guides is typically available on the respective installation CD. You can easily print information from the PDF files. The documentation is also available as online help files through respective application interface or on the Wonderware Developer Network (a valid login is required) System Platform 3.1 The System Platform documentation set includes the following guides: System Platform Getting Started Guide. Application Server 3.1: Creating and Managing ArchestrA Graphics User s Guide Application Server 3.1: Application Server Scripting Guide Application Server 3.1: Platform Manager User s Guide The Platform Manager User s Guide provides information on performing runtime administrative tasks and diagnostics on ArchestrA Application Server platforms and engines. Application Server 3.1: Object Viewer User s Guide This guide describes the user interface and functions of the Object Viewer utility. Application Server 3.1: Wonderware Application Server User s Guide. Page 3

5 Application Server 3.1: Galaxy Database Manager User s Guide This guide describes the user interface and functions of the Galaxy Database Manager, a part of the ArchestrA System Management Console suite of utilities. Protocol Users Guide This guide provides background information on the main protocols used between components of Wonderware products. Wonderware FactorySuite A2 Deployment Guide (Updated) This Wonderware FactorySuite A2 Deployment Guide provides recommendations and best practice information so that you can effectively define architectures and design and implement projects in a Wonderware FactorySuite A2 environment. Industrial Application Server Installation Guide - Version 2.0 This document describes how to install one or more components of the Industrial Application Server infrastructure, including the main configuration tool, the Integrated Development Environment (or IDE), and the Galaxy Repository InTouch 10.1 The InTouch documentation set includes the following guides: Guide to InTouch HMI Documentation InTouch HMI Concepts and Capabilities Guide InTouch HMI Application Management and Extension Guide InTouch HMI Data Management Guide InTouch HMI Visualization Guide InTouch HMI SmartSymbols Guide InTouch HMI and ArchestrA Integration Guide InTouch HMI Alarms and Events Guide InTouch HMI Scripting and Logic Guide InTouch HMI Supplementary Components Guide InTouch HMI Getting Started Guide InTouch Protocol Guide Wonderware Historian 9.0 The Wonderware Historian documentation set includes the following guides: Wonderware Historian 9.0 Runtime Database Schema Wonderware Historian 9.0 Administration Guide This Wonderware Historian Administration Guide provides information on how to administer and maintain an installed Wonderware Historian. This guide describes the tools you will use to administer the Wonderware Historian, as well as how to configure the system to start storing plant data. This guide also describes administration tasks such as changing the default security, configuring system-wide parameters, and monitoring the system. Wonderware Historian 9.0 Concepts Guide This Wonderware Historian Concepts Guide provides information about the general architecture of the Wonderware Historian system and describes the different subsystems and components that make up the system. This guide can be used as a reference guide for all conceptual information regarding various Wonderware Historian components. Wonderware Historian 9.0 Database Reference. This Wonderware Historian Database Reference describes the database model of the Wonderware Historian system. Each database entity is described, and the relationships between the entities are defined. Wonderware Historian 9.0 Installation Guide. This IndustrialSQL Server Installation Guide provides information on installing Wonderware Historian, including hardware and software requirements and migration instructions. Wonderware Historian Glossary. This Wonderware Historian Glossary provides definitions used throughout the Wonderware Historian documentation set. Page 4

6 1.2.4 Notes on System Architecture Options Wonderware s software components can be used to design industrial IT systems using several architectures, according to the exact requirements of a customer. The choice of architecture can impact the best practices for designing an application to be validated. The Wonderware System Platform is a suite of products which provides a powerful and common framework for building industrial applications. System Platform integrates security, data quality, communications and alarming within an infrastructure of common services. System Platform also includes Wonderware Historian (formerly known as IndustrialSQL Server) for recording of historical data values, and Wonderware Information Server (formerly SuiteVoyager) as an information portal. InTouch can be used as a visualization client to the System Platform. InTouch can also be used in a stand-alone mode or as a managed application without System Platform, where the configuration data is stored in a tag database. Wonderware Historian is a component of System Platform, and can also be used in combination with InTouch tag based applications or in a stand-alone mode, for example when different HMI system(s) are already in place. Section 4 Technological Control describes Wonderware product features, according to the different architectural options, that support 21 CFR Part 11 compliance. 1.3 Other References & Documentation CFR Part 11 Documentation on 21 CFR Part 11 can be obtained from the following sources: Electronic Records; Electronic Signatures Final Rule, 62 Federal Register (March 20, 1997). This Code of Federal Regulation is the official rule on Electronic Records and Electronic Signatures management for FDA-audited industries. Risk-Based Approach to 21 CFR Part 11 (August 2003) The purpose of this ISPE White Paper is to describe how a risk-based approach to Part 11 could be used to benefit patient health while adversely impacting industry productivity. Guidance for Industry, Part 11, Electronic Records; Electronic Signatures Scope and Application (August 2003) The purpose of this guidance is to describe the FDA s re-examination of 21 CFR Part 11. Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures, Part 2 (September 2001) This document produced by ISPE and PDA was developed to provide a better understanding of 21 CFR Part 11. It aims to provide guidance for the industry on how to comply with the requirements. Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps (February 2002) The purpose of this draft guidance is to describe the FDA s current thinking regarding the time stamp requirements of 21 CFR Part Validation Good Automated Manufacturing Practice (GAMP) 5 This document is a guideline, used widely within FDA-regulated industries, for validation of computer systems. ISPE and the GAMP Forum produce the GAMP Guide. ( General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002). This guidance presents principles of software validation considered to be applicable by the FDA. ( guidance/938.html) Pharmaceutical cgmps for the 21st Century: A Risk-Based Approach; A science and risk-based approach to product quality regulation incorporating an integrated quality systems approach (2002). This describes the FDA s review of cgmps and defines specific immediate, intermediate, and long term steps for the FDA s review. ( FDA documents can be downloaded off the FDA s web site at and guides developed by ISPE can be bought through ISPE at Page 5


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