70-6676 Getting Started- CoulArrayÂ® Data Station V3 - VTP UP

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Chapter 1• Compliant mode – Access to the system is password protected, operations arelimited to designated individuals, and an audit trail is automatically kept of alloperations that affect the acquisition and analytical treatment of data. Compliantmode is designed to help satisfy the requirements of the US Food and DrugAdministration (FDA) as described in 21 CFR Part 11.The key features of compliant mode include:a) Operation of the system is restricted to individuals who have beenauthorized by the system administrator. A user must log in with his/hername and password.b) A user can perform only those operations that have been permitted bythe system administrator.c) The integrity of the methods, and of the data that has been collectedand processed, is maintained and an audit trail is generated for methodsand chromatograms. Method files, study files and chromatogram filesare stored in a secure file (rather than as discrete files that can beviewed using Windows Explorer), and cannot be deleted directly.d) One or more electronic signatures can be appended to a chromatogramfile by any qualified user to certify its validity.NOTE: The installer must determine whether the system should beoperated in standard or compliant mode when the software is installed(Chapter 2). Once the system has been configured for compliant mode, it isnot readily converted to standard mode. For initial installation, it is highlyrecommended that standard (non-compliant) mode be installed, even if thecompliant mode feature has been purchased. This will greatly facilitate users’familiarization with the CoulArray ® software and instrumentation beforeimplementing features that address 21 CFR Part 11 compliance. Thesefeatures are easily added at a later time, as described in Section 2.7.1.4 For More InformationThe following documents should be used in conjunction with this manual:• CoulArray ® Data Station 3.00 Applications Software Manual (provided as a PDFfile on the installation CD-ROM).• CoulArray ® Operating Manual (Part Number 70-1793).• Windows documentation provided by Microsoft Corporation.2 CoulArray ® Data Station 3.00Getting Started Manual
2. Software Installation and Configuration2.1 OverviewThe CoulArray ® Data Station application software must be loaded onto the hard drive of thecomputer as part of the instrument installation. This chapter describes the installation processand the minimum computer configuration required for operation.2.2 The System ComputerThe minimum recommended computer configuration is:• Intel ® Pentium ® Microprocessor – 2.0 GHz• Operating System: Windows XP Professional (with SP1 or greater) or Windows2000 Professional• 512 MB RAM• 80 GB Hard Disk• 3.5” Floppy Disk Drive (1.44 MB) – optional• CD-ROM Drive• 17” Monitor - Minimum Display Resolution: 1024 x 768 Pixels• Mouse• 2 RS-232 COM Ports (9-Pin)The CoulArray ® application software should be used on a computer that is either supplied byESA Biosciences (or its local representative) or that has been approved by ESA Biosciences.If you are using a laptop computer, make certain that the power management feature isdisabled.NOTE: If you must use a computer that has been obtained from anoutside source, or for complete information about computer compatibilityissues, please contact your local ESA Biosciences Service Representative.For best results with the CoulArray ® Data Station software, a printer driver should beinstalled as part of the Windows configuration. Even if the computer system does not includea printer, installing any standard printer driver supplied with Microsoft ® Windows will allowfor print previewing of chromatogram reports and methods.CoulArray ® Data Station 3.00 3Getting Started Manual
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70-6676 Getting Started- CoulArrayÂ® Data Station V3 - VTP UP

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