Agilent G1732AA MSD Security ChemStation Manager Guide detector data only in combination with GC/MSD

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Transcript of Agilent G1732AA MSD Security ChemStation Manager Guide detector data only in combination with GC/MSD

  • Agilent G1732AA MSD Security ChemStation

    Manager Guide

    Agilent Technologies

  • 2 Manager Guide

    Notices © Agilent Technologies, Inc. 2004

    No part of this manual may be reproduced in any form or by any means (including elec- tronic storage and retrieval or translation into a foreign language) without prior agree- ment and written consent from Agilent Technologies, Inc. as governed by United States and international copyright laws.

    Manual Part Number G1732-90001

    Edition First edition, March 2004

    Printed in USA

    Agilent Technologies, Inc. 2850 Centerville Road Wilmington, DE 19808-1610 USA

    Warranty

    The material contained in this docu- ment is provided “as is,” and is sub- ject to being changed, without notice, in future editions. Further, to the max- imum extent permitted by applicable law, Agilent disclaims all warranties, either express or implied, with regard to this manual and any information contained herein, including but not limited to the implied warranties of merchantability and fitness for a par- ticular purpose. Agilent shall not be liable for errors or for incidental or consequential damages in connec- tion with the furnishing, use, or per- formance of this document or of any information contained herein. Should Agilent and the user have a separate written agreement with warranty terms covering the material in this document that conflict with these terms, the warranty terms in the sep- arate agreement shall control.

    Technology Licenses The hardware and/or software described in this document are furnished under a license and may be used or copied only in accor- dance with the terms of such license.

    Restricted Rights Legend If software is for use in the performance of a U.S. Government prime contract or subcon- tract, Software is delivered and licensed as “Commercial computer software” as defined in DFAR 252.227-7014 (June 1995), or as a “commercial item” as defined in FAR 2.101(a) or as “Restricted computer soft- ware” as defined in FAR 52.227-19 (June 1987) or any equivalent agency regulation or contract clause. Use, duplication or disclo- sure of Software is subject to Agilent Technologies’ standard commercial license terms, and non-DOD Departments and Agencies of the U.S. Government will

    receive no greater than Restricted Rights as defined in FAR 52.227-19(c)(1-2) (June 1987). U.S. Government users will receive no greater than Limited Rights as defined in FAR 52.227-14 (June 1987) or DFAR 252.227-7015 (b)(2) (November 1995), as applicable in any technical data.

    Safety Notices

    CAUTION

    A CAUTION notice denotes a haz- ard. It calls attention to an operat- ing procedure, practice, or the like that, if not correctly performed or adhered to, could result in damage to the product or loss of important data. Do not proceed beyond a CAUTION notice until the indicated conditions are fully understood and met.

    WARNING

    A WARNING notice denotes a hazard. It calls attention to an operating procedure, practice, or the like that, if not correctly per- formed or adhered to, could result in personal injury or death. Do not proceed beyond a WARNING notice until the indicated condi- tions are fully understood and met.

    Acknowledgements Microsoft®, Windows®, Windows 2000®, and Windows XP® are U.S. registered trademarks of Microsoft Corporation.

    InstallShield® is a registered US trademark of InstallShield Corporation.

    Software Revision This manual is valid for A.01.xx revisions of the Agilent G1732AA MSD Security Chem- Station software, where xx refers to minor revisions of the software that do not affect the technical accuracy of this manual.

  • In this guide. . . This Manager Guide contains information and procedures needed for the administration of the G1732AA MSD Security ChemStation.

    1 Introduction

    This chapter describes the purpose of the MSD Security ChemStation and provides brief descriptions of the other chapters.

    2 21 CFR Part 11 Compliance

    This chapter compares the requirements of the 21 CFR Part 11 regulations with the features of the Agilent G1732AA MSD Security ChemStation. It identifies those requirements that are satisfied by the software and those that are the responsibility of the users, system administrators, and the organization that employs them.

    3 Manager Tasks

    The final chapter contains procedures for the duties that a Manager must perform, including instrument configuration, user management, archive management, and related tasks.

    Manager Guide 3

  • 4 Manager Guide

  • Contents

    1 Introduction

    The Security ChemStation 10

    Capabilities and limitations 10 Hardware and communications 10 Product design 10 Security groups and users 11 The Windows Administrator 12 Electronic records and signatures 12 Audit trails 13 Archiving and restoration 13 Uninstalling 13

    Standard Operating Procedures 15

    2 21 CFR Part 11 Compliance

    Subpart A–General Provisions 18

    Subpart B–Electronic Records 21

    Subpart C–Electronic Signatures 26

    3 Manager Tasks

    Completing Installation (Configuring Instruments) 33

    Managing Users 37

    Creating a new user 37

    New user initial login 40 Electronic signatures 40 Disabling a user 41

    Manager Guide 5

  • Managing Passwords 42

    Password rules 42 Password aging 42 Account lockout 43 Good password practices 43 Final word 43

    Removing (Uninstalling) MSD Security ChemStation Software 44

    File and Directory Names 46

    Version files 46 Version file name syntax 46 Run directories 47

    Managing Archives 48

    Importing and Exporting Data and Methods from a Different ChemStation 49

    Import 49 Export 49

    The MSD Security Monitor 50

    The Default Printer 51

    Setting or changing the default printer 51

    Audit Trails 52

    Method, sequence, and data audit files 52 Event Viewer logs 52 Notes for users running Windows® 2000 60

    Unlocking Methods 62

    Set Data Path 63

    Predefined structure 64

    User-defined structure 64

    6 Manager Guide

  • To Save a Method in the \METHODS Directory 66

    Example: Adding a Quant database to a method using AutoQuant Setup 66

    To Reprocess a Sequence 67

    View Previously-Generated Reports 68

    Manager Guide 7

  • 8 Manager Guide

  • Agilent G1732AA MSD Security ChemStation Manager Guide

    1 Introduction

    The Security ChemStation 10

    Capabilities and limitations 10

    Hardware and communications 10

    Product design 10

    Security groups and users 11

    The Windows Administrator 12

    Electronic records and signatures 12

    Audit trails 13

    Archiving and restoration 13

    Uninstalling 13

    Standard Operating Procedures 15

    The Agilent “G1732AA MSD Security ChemStation” and the “G1742AA MSD Security ChemStation Upgrade” are designed to support the requirements of the U.S. Food and Drug Administration (FDA) regulations on the handling of electronic records and electronic signatures published as 21 CFR Part 11.

    The systems, hereafter referred to as the MSD Security ChemStation, acquire data from one Agilent 5973 Series Mass Selective Detector (MSD) mounted on an Agilent 6890 Series Gas Chromatograph (GC).

    NOTE The G1732AA MSD Security ChemStation is software that should be installed on a computer dedicated to this specific application. This software can support either GPIB or local LAN acquisition from one MSD instrument. Other applications and/or wide area network access should be performed on other computers.

    9Agilent Technologies

  • Introduction

    The Security ChemStation

    The Agilent G1732AA MSD Security ChemStation is a conventional MSD ChemStation with support for U.S. Food and Drug Administration (FDA) 21 CFR Part 11 regulations. These regulations govern the use of electronic records, electronic signatures, and auditability of systems used in regulated laboratories.

    Chapter 2 compares the FDA 21 CFR Part 11 text with the properties of the Agilent system.

    Chapter 3 describes the tasks that are performed by an MSD Security ChemStation Manager.

    Capabilities and limitations

    The MSD Security ChemStation supports the same hardware as the standard MSD Productivity ChemStation. However, it is focused on GC/MSD signal acquisition and will acquire GC detector data only in combination with GC/MSD data acquisition. It will also import and process existing GC/MSD files that contain GC data.

    Hardware and communications

    The ChemStation is designed for a system consisting of a personal computer (PC), a hub or bridge, a 6890 or 6890N gas chromatograph (GC), and a 5973 Mass Selective Detector (MSD). These components communicate either via an isolated local area network (LAN) or GPIB. Use on a site LAN is not supported.

    Product design

    The MSD Security ChemStation is a standalone application that addresses the requirements of 21 CFR Part 11 through a combination of operating system facilities and programmatic controls. It ships with Microsoft Windows operating system and takes advantage of its inherent user access security capabilities. File access privileges are defined on a per user basis for data

    10 Manager Guide

  • Introduction

    files, methods, sequences, and results. The operating sy