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  • Secure Workstation for OpenLAB CDS ChemStation Edition

    User's GuideSecure Workstation for OpenLAB CDS ChemStation Edition User's Guide

    Agilent Technologies

  • Notices Agilent Technologies, Inc. 2014-2017No part of this manual may be reproduced in any form or by any means (including electronic storage and retrieval or transla-tion into a foreign language) without prior agreement and written consent from Agi-lent Technologies, Inc. as governed by United States and international copyright laws.

    Manual Part NumberM8313-90014

    Edition09/2017Printed in GermanyAgilent TechnologiesHewlett-Packard-Strasse 8 76337 Waldbronn

    WarrantyThe 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 connection with the furnishing, use, or perfor-mance 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 accordance with the terms of such license.

    Restricted Rights LegendIf software is for use in the performance of a U.S. Government prime contract or sub-contract, 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 software as defined in FAR 52.227-19 (June 1987) or any equivalent agency regu-lation or contract clause. Use, duplication or disclosure of Software is subject to Agi-lent 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 hazard. It calls attention to an operating procedure, practice, or the like that, if not correctly per-formed 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 condi-tions 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 performed or adhered to, could result in personal injury or death. Do not proceed beyond a WARNING notice until the indi-cated conditions are fully understood and met.

    Software RevisionThis guide is valid for Secure Workstation for OpenLAB CDS ChemStation Edition C.01.08.

    Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide

  • In This Guide ...

    In This Guide ...

    This guide contains information on working with the Secure Workstation for OpenLAB CDS ChemStation Edition. It describes the settings required by 21 CFR Part 11, and provides information on the workflows using the Secure Workstation.

    Table 1 Terms and abbreviations used in this document

    Term Description

    CDS Chromatography Data System

    ChemStation OpenLAB CDS ChemStation Edition

    Secure Workstation Secure Workstation for OpenLAB CDS ChemStation Edition

    Data Store OpenLAB Data Store; as of rev. 2.1, the product name is OpenLAB Server

    OpenLAB Server Data Storage product, formerly known as OpenLAB Data Store.

    Content Management Data storage component provided as part of OpenLAB Server

    ECM OpenLAB Enterprise Content Manager

    AIC Agilent Instrument Controller

    Control Panel OpenLAB Control Panel

    Microsoft Control Panel Part of the Microsoft Windows operating system

    Shared Services Set of components and services for licensing, users and roles, instrument configuration, security policy and more.Installed on all computers; accessed via the OpenLAB Control Panel.

    OpenLAB CDS Shared Services Server Server running the Shared Services.Formerly known as OpenLAB Shared Services Server.

    Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide 3

  • In This Guide ...

    1 IntroductionThis chapter introduces Secure Workstation for OpenLAB CDS ChemStation Edition. It also describes the requirements of 21 CFR Part 11.

    2 Basic ConceptsThis chapter describes how to log in to Secure Workstation for OpenLAB CDS ChemStation Edition, explains the user interface items and toolbars related to Content Management, and describes the main preference settings.

    3 Working with Secure WorkstationThis chapter describes the basic workflows for Secure Workstation for OpenLAB CDS ChemStation Edition. There are four data-related workflows and two workflows for methods, sequence templates, or report templates.

    4 Administration Regarding 21 CFR Part 11 ComplianceThis chapter explains the purpose of 21 CFR Part 11 and how Secure Workstation for OpenLAB CDS ChemStation Edition addresses the requirements of 21 CFR Part 11.

    5 Filter and Search OptionsThis chapter provides an overview of the filter and search options for ChemStation data in the Content Management system.

    6 Troubleshooting

    The chapter gives some troubleshooting hints.

    4 Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide

  • Contents

    Contents

    1 Introduction 7What is Secure Workstation? 8Using Secure Workstation 9Storage Model 1521 CFR Part 11 Compliance 16

    2 Basic Concepts 17License Management 18Login and Lock Options 20User Interface in ChemStation Related to Content Management 22Preferences 27Remote Data Path as Sequence Parameter 38Compressed ChemStation File Formats 40

    3 Working with Secure Workstation 41Transferring Data to or from the Repository 42Data-related workflows 43Workflows for Methods and Templates 53

    4 Administration Regarding 21 CFR Part 11 Compliance 63Introduction to 21 CFR Part 11 65Overview of Configuration Steps Required for Part 11 68Audit Trails and Logbooks 69Security Policy 75Users/Groups/Roles Configuration 79ChemStation Administration Tool 84Electronic Signature 93

    5 Filter and Search Options 95Using the Advanced Search 96

    Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide 5

  • Contents

    6 Troubleshooting 97Error messages at OpenLAB Control Panel Startup 98Alerts and Error Messages at ChemStation Startup 99Content Management is not available after login 100Error Messages in the Queue Management 101Other Error Messages 103

    7 Appendix 105Privileges in OpenLAB Control Panel 106

    6 Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide

  • Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide

    1IntroductionWhat is Secure Workstation? 8Using Secure Workstation 9

    Overview of data-related workflows 11Overview of workflows for methods/sequence templates/report templates 13

    Storage Model 1521 CFR Part 11 Compliance 16

    This chapter introduces Secure Workstation for OpenLAB CDS ChemStation Edition. It also describes the requirements of 21 CFR Part 11.

    7Agilent Technologies

  • 1 IntroductionWhat is Secure Workstation?

    What is Secure Workstation?

    Secure Workstation for OpenLAB CDS ChemStation Edition combines ChemStation Workstation and Content Management on one PC. It provides secure data storage for one LC/MSD, one CE/MSD, or up to two LC, GC, A/D, CE or SFC instruments.

    Content Management allows you to easily store, organize, search, and review your ChemStation data. It automatically extracts searchable metadata from files, and provides powerful search capabilities.

    In this document, the term repository refers to the Content Management database.

    8 Secure Workstation for OpenLAB CDS ChemStation Edition User's Guide

  • Introduction 1Using Secure Workstation

    Using Secure Workstation

    Secure Workstation for OpenLAB CDS ChemStation Edition enables you to acquire, analyze, and securely store analytical data and reports on a single machine. It provides the full Content Management functionality of the Agilent OpenLAB Server solution. You can store all your ChemStation files in the data repository:

    Methods (*.m)

    Sequence templates (*.s)

    Data files (*.d)

    Report templates for Intelligent Reporting (*.rdl)

    Reports (*.pdf, *.xls, *.doc, or *.txt)

    Library files (*.uvl)

    Column databases (*.mdb)

    Easy Sequence templates (*.est)

    Classic report templates (*.frp)

    The storage of ChemStation data can be either automatic (that is, at the end of a single run or sequence) or manual. A manual storage is possible only when you already have a version in the system. The data can be downloaded later to ChemStation for review or reprocessing at any time.

    Furthermore, Secure Workstation for OpenLAB CDS ChemStation Edition offers features that enable users to comply with 21 CFR Part 11 and similar regulations for electronic records and electronic signatures:

    Mandatory login

    Configurable session locking

    Configurable ChemStation user roles and privileges

    Full data tra