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

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Chapter 2NOTE: Certain programs (e.g., Fast Find in Microsoft ® Office ® ) operatepersistently in the background. If a program that operates in the backgrounduses significant resources while data acquisition is being performed, it ispossible that the integrity of the data acquisition procedure may becompromised. This may manifest itself in a check sum error, causing theData Station program to issue an error message. If this is observed, turn offall unnecessary programs that may be running in the background.NOTE: The system computer should be configured to not use any ofthe Windows power management features, especially automatic shut downof the hard drive or monitor during periods of inactivity. In addition, it isstrongly recommended that screen savers not be used.2.3 Before Installing the SoftwareVersion 3.00 of the CoulArray ® Data Station software introduces these new features to thesystem:• Optional support for 21 CFR Part 11 compliant operation (requires special license).• Integrated acquisition and processing modules (no longer separate programs).• Dual sampling rate support – standard 2 Hz, and new 10 Hz for fast chromatography.2.3.1 Compliant Mode OperationAs a specially licensed option from ESA Biosciences, the new Data Station software wasdesigned to offer integrated support for maintaining compliance with the Food and DrugAdministration’s regulations for electronic records and electronic signatures, as specified inTitle 21 of the Code of Federal Regulations (21 CFR Part 11). During initial installation ofthe software, a decision must be made whether or not to include 21 CFR Part 11 compliancesupport in the operation of the program (compliant mode operation). This decision must notbe taken lightly, since it has significant consequences (see below).For initial installation, it is highly recommended that 21 CFR Part 11 compliancesupport be postponed until after users have had an opportunity to become familiar withthe CoulArray ® software and instrumentation.In this manual, operation of the system with support for 21 CFR Part 11 compliance isreferred to as Compliant Mode operation. Operation that does not include 21 CFR Part 11support is referred to as Standard Mode operation.Although it is possible to convert the system back from compliant mode to standard modeoperation, studies and chromatograms acquired in compliant mode cannot be readilyconverted to non-compliant form (requires archiving in compliant mode, and restoring in4 CoulArray ® Data Station 3.00Getting Started Manual
Software Installation and Configurationstandard mode), and methods created in compliant mode cannot be accessed at all on astandard (non-compliant) system.Likewise, chromatogram files that are acquired in standard (non-compliant) mode cannot betreated as compliant in a compliant system, and method files created in standard modecannot be accessed by a compliant system.These considerations should be weighed before deciding whether to install the software instandard (non-compliant) or compliant mode. For a complete description of the extrarequirements imposed by compliant mode systems, please refer to Chapter 3 of theApplications Software Manual.IMPORTANT: During the installation process, the decision to operatethe CoulArray ® software in either compliant mode or standard mode must bemade. For initial installation, it is highly recommended that standard (noncompliant)mode be installed, even if the compliant mode feature has beenpurchased. This will greatly facilitate users’ familiarization with theCoulArray ® software and instrumentation before implementing features thataddress 21 CFR Part 11 compliance. For a complete description of the extrarequirements imposed by compliant mode systems, please refer to Chapter 3of the Applications Software Manual.CoulArray ® Data Station 3.00 5Getting Started Manual
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70-6676 Getting Started- CoulArrayÂ® Data Station V3 - VTP UP

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