Agilent Cary WinUV Pharma Revision 5.1.3 – Site Preparation Checklist
Souhrn
Význam tématu
Správná příprava místa instalace je klíčovým předpokladem pro spolehlivý a dlouhodobý provoz analytického systému Agilent Cary WinUV Pharma v souladu s požadavky farmaceutické regulace 21 CFR Part 11. Dokument definuje technické, prostorové, softwarové a síťové požadavky, které musí zákazník splnit před instalací.
Cíle a přehled dokumentu
Checklist slouží jako průvodce pro:
- Posouzení fyzických a síťových podmínek laboratoře
- Přípravu počítačového prostředí (hardware, operační systém, zálohování)
- Zajištění potřebných softwarových licencí a instalací (SQL Server, .NET Framework)
- Koordinaci s IT oddělením a zajistění dostupnosti administrátorů
Použitá metodika a instrumentace
Instalace a konfigurace vyžaduje:
- Spektrofotometr Agilent Cary 603 (verze firmwaru 6.4.0.141, anglická lokalizace)
- Software Cary WinUV Pharma verze 5.1.3.12421 s podporou 21 CFR Part 11
- Microsoft SQL Server 2014 Express
- Microsoft .NET Framework 3.5 SP1 nebo 4.5.1
- Windows 10 Pro/Enterprise 64-bit nebo Windows Server 2008 R2 / 2012 R2
Hlavní poznatky a diskuse
Dokument podrobně popisuje:
- Požadavky na výkon počítačů (quad-core CPU, min. 4 GB RAM, 250 GB HDD)
- Doporučené nastavení operačního systému (lokální administrátorské účty, vypnuté spořiče, firewall výjimky)
- Konfigurační scénáře: samostatné (standalone) i síťové instalace (s odděleným serverem SDA a SCM)
- Potřebu zálohování dat před migrací a upgradem
- Role IT specialisty při nasazení a validaci systému
Přínosy a praktické využití metody
Pečlivé dodržení specifikací:
- Zkracuje dobu a riziko neúspěšné instalace
- Umožňuje plné využití funkcí pro správu elektronických záznamů a auditních stop
- Zajišťuje kompatibilitu se všemi komponentami prostředí farmaceutické kvality
Budoucí trendy a možnosti využití
Systém Cary WinUV Pharma bude nadále integrovat cloudové zálohování a monitorování stavu zařízení v reálném čase. Rozvoj virtualizace serverů a přechod na novější SQL platformy rozšíří možnosti centralizované správy laboratoří ve více lokalitách.
Závěr
Dokument představuje komplexní návod pro přípravu laboratoře na instalaci Agilent Cary WinUV Pharma. Důsledné naplnění všech požadavků minimalizuje rizika při uvádění systému do provozu a podporuje plnou regulační shodu.
Reference
- Agilent Cary WinUV Pharma Software Installation Instructions for 21 CFR Part 11
- Spectroscopy Configuration Manager System Requirements
- Agilent Cary WinUV Version 5.1.3 Release Notes
Obsah byl automaticky vytvořen z originálního PDF dokumentu pomocí AI a může obsahovat nepřesnosti.
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 1 of 10
Thank you for purchasing an Agilent instrument. To get you started and to assure a successful and
timely installation of your Agilent Cary WinUV Pharma software, please refer to this specification and
set of requirements.
Correct site preparation is the key first step in ensuring that your instruments and software systems
operate reliably over an extended lifetime. This document is an information guide and checklist that
outlines the supplies, consumables, space and utility requirements for your equipment.
Customer Responsibilities
Make sure your site meets the following specifications before the installation date. For
details, see specific sections within this checklist, including:
❑ The computing environment and the necessary space is made available
❑ The number & location of electrical outlets for your computer systems and peripherals are planned
❑ That your site meets the software, hardware and networking specifications below
❑ Locate your sales order information, software authorization codes and/or software
licenses/certificates
❑ The necessary software media, disks etc. are available including upgrade/update disks
❑ That a suitable backup solution is identified for your software
❑ Availability of a system/network administrator as needed to connect to your network and configure
the system
❑ Please consult Other Requirements section below for other product-specific information.
If Agilent is delivering installation and familiarization services, users of the instrument
should be present throughout these services; otherwise, they will miss important
operational, maintenance and safety information.
❑ For more details about the installation requirements of Cary WinUV Pharma, please consult the
following documents for your version of Cary WinUV Pharma:
o Agilent Spectroscopy Configuration Manager System Requirements
o Agilent Cary WinUV Pharma Software Installation Instructions for 21 CFR Part 11
Environments
o And the Spectroscopy Configuration Manager (SCM) Software, 21 CFR Part 11
Compliance Booklet
o Agilent Cary WinUV version 5_1_3 Release Notes
o Agilent Cary UV Pharma SSB
o Agilent Cary WinUV SSB
❑ Additional, up-to-date information is available in the Agilent Cary WinUV Pharma SSB.
❑ These documents will be provided to you with the purchase of your Cary WinUV Pharma software
but please ask your Agilent representative to provide them to you for review before purchase or
arrival for installation by your Agilent representative.
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 2 of 10
Important Customer Information
1. If you have questions or problems in providing anything described as a Customer Responsibility
above, please contact your local Agilent or partner support/service organization for assistance
prior to delivery. In addition, Agilent and/or its partners reserve the right to reschedule the
installation dependent upon the readiness of your laboratory.
2. Should your site not be ready for whatever reasons, please contact Agilent as soon as possible to
re-arrange any services that have been purchased.
3. Other optional services such as additional training, operational qualification (OQ) and
consultation for user-specific applications may also be provided at the time of installation when
ordered with the system, but should be contracted separately.
4. You should ensure that all necessary operating supplies for the successful installation of
instruments and systems are available. Installation sites should be prepared in accordance with
the information outlined in this document.
Important Version and Hardware Information
1. Please refer to Table 1 for supported Cary WinUV and hardware configurations.
Table 1. Supported Hardware, Software and Firmware Combinations
Supported Cary WinUV Pharma and Instrument Configurations
Cary WinUV Version
Cary Pharma Version
Supported Instrument
Hardware
Comments
(if applicable)
5.1.3.1242
1
5.1.3
2
Agilent Cary 60
3
1. FW 6.4.0.141
2. English only
3. Cary 50 is not tested
or supported for this
release
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 3 of 10
Software Specifications for
Workstations, Clients, and Servers (Pharma)
Special Notes
1. Implement a backup strategy or backup all of your data before making any changes.
2. No other instrument control software must be installed.
3. A user logon with full administrative capabilities is required.
4. Upgrading from Cary WinUV Pharma version 5.0.0.1004 or earlier will require updates to the PC
or operating system. This means an upgrade cannot be installed over an existing installation.
5. If upgrading from Cary WinUV Pharma 5.0.0.1005 or later, Cary WinUV does not need to be
uninstalled butyou must manually uninstall both the SCM and SDA applications. Please follow
the upgrade instructions in the Agilent Cary WinUV Pharma Software Installation Instructions
for 21 CFR Part 11 manual. Failure to follow the instructions exactly may require the PC needing
to be reimaged.
6. Upgrading the Cary WinUV Pharma software requires backing up SCM settings and SDA
databases so they can be used for the new system. Make sure the instructions in the manual
above are followed otherwise data/setting loss will occur.
There are some administrative tasks that need to be performed before and after installation of
Cary WinUV Pharma - refer to Table 2 and the rest of this document and the Pharma software
installation booklet.
Table 2. Supported Operating Systems and Settings
Specification Description
Supported
Comments
(if applicable)
Operating system type(s),
versions
Windows 10 Professional1, 2, 3, 4
Windows 10 Enterprise1, 2, 3, 4
Windows Server 2008 R2 SP11, 3, 4
Windows Server 2012 R2 1, 3, 4
1. 64-bit only
2. Cary 60 only
3. English only for Pharma
4. Manual install of .NET
Framework 3.5 SP1 is
required
Account settings/privileges
Full Local Administrator Rights
Required for installation,
configuration, upgrade or
modification
Microsoft Windows Updates
Outstanding updates must be completed or
must not start before installing software
Disconnect the PC from the
network while performing the
installation and configuration
Power Saving
Not supported
Any PC power saving
functions should be disabled
SQL Server
Microsoft SQL Server 2014 Express Ed.
The Hardware and Software
Requirements for Installing
SQL Server 2014 must be met
Microsoft .Net
3.5
Must be installed before
installation of WinUV Pharma.
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 4 of 10
Cary WinUV Pharma Scenario Options
Special Notes
1. Cary WinUV Pharma allows for installation in different scenarios (Table 3)
2. The scenario chosen depends on the desired configuration for collection of data and control of
electronic records using the Pharma application.
3. Scenario 1 is for local computer installations (using local or domain users)
4. Scenario 2 and 3 is for installation over a network
5. You must decide on the scenario being used for your installation before your Agilent
representative arrives onsite.
6. For Scenarios 2 and 3, your IT support personnel must be present during the installation and
configuration. If they are not present, it is possible that installation cannot be completed in the
allotted time and this may result in extra charges.
7. Refer to the Table 3 for the Scenario options
8. Terminology:
a. The software used to run the instrument is known as the 'application software'.
b. Spectroscopy Configuration Manager (SCM) provides you with a tool to manage your 21
CFR Part 11 environment by allowing you to create, configure and maintain data in
relation to system security, user management and data paths.
c. Spectroscopy Database Administrator (SDA) provides a database environment to store
and maintain your data.
d. The IT Server (Scenario 2/3): is the computer where the data is stored
e. The Laboratory Management Computer (Scenario 2): is where the users, profiles and
privileges are managed
9. Installation outside of the instructions provided will require external IT support and independent
validation.
Table 3. Scenarios
Options
Scenario 1
• All software is installed on the computer connected directly to the instrument
Scenario 2
• Application software is installed on the instrument computer
• SCM is installed on the laboratory management computer
• SDA is installed on an IT server.
Scenario 3
• Application software is installed on the instrument computer
• SDA and SCM are installed on IT server.
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 5 of 10
Software Specifications for Cary WinUV Pharma (Standalone)
Special Notes
1. Implement a backup strategy or backup all of your data before making any changes.
2. Before you install your software, please check with your network administrator that the
computer has a unique name that will not be changed in the future. If the computer is to be
connected to a domain, please ensure that this is completed before installing your software.
3. Agilent strongly recommends that your software is installed while logged in as a domain user
with administrative privileges.
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 6 of 10
Software Specifications for Cary WinUV Pharma (Network)
Special Notes
1. Implement a backup strategy or backup all of your data before making any changes.
2. Before you install your software, please check with your network administrator that the
computer has a unique name that will not be changed in the future. If the computer is to be
connected to a domain, please ensure that this is completed before installing your software.
3. It is essential that support from an IT representative is available. They will need to assist in
allowing the required access to the domain, the creation of domain groups and the assignment of
users to their target groups if required. See Table 4 for more information.
4. A user with local administrator rights for the IT Server and for the Workstation is required so
configuration can take place.
5. A Domain user used for the installation must exist and the global groups to handle Cary WinUV
users must be available.
6. A global account for the Cary WinUV administration is required.
7. The target computers for the installation must be members of the Domain.
8. The domain server and the server for the data must be different machines.
9. Please review the document "Agilent Cary WinUV Pharma Software Installation Instructions for
21 CFR Part 11" for further information.
10. Having Cary WinUV operate within a Cary WinUV Pharma in a network environment, requires
some configuration tasks on the Cary WinUV Pharma Server.
Table 4. Important Network Requirements
Specification Description
Supported
Comments
(if applicable)
Agilent Spectroscopy
Configuration Manager System
Requirements
Microsoft Windows 2008 Active Directory
– Single Forest / Single Domain model
environment
Network Active Directory/Domain
Users
Yes1
1. Active Directory is required
if using network domain users
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 7 of 10
Required Configuration Items
Special Notes
1. Particularly in the case of network installations, several software services and applications must
not be prevented from running or getting access through the computer firewall.
2. Implement a backup strategy or backup all of your data before making any changes.
3. Before you install your software, please check with your network administrator that the
computer has a unique name that will not be changed in the future. Changes to this configuration
item after installation and configuration will result in a non-operational system. This is not
covered under any warranty services and extra costs may be involved if a site visit is required to
rectify this.
4. If the computer is to be connected to a domain, please ensure that this is completed before
installing your software.
5. Agilent requires that your software is installed while logged in as a domain user with
administrative privileges.
Table 5. Configuration Items
Specification Description
Supported
Comments
(if applicable)
Region and Language
settings/compatibility
English
Only English is supported for
Pharma
.Net Framework
Microsoft .NET Framework 3.5 or 4.5.1
Add as exceptions to the Windows
Firewall
• sqlservr.exe
• sqlbrowser.exe
• nxServer.exe
• configManager.exe
It may also be necessary to
open firewall ports: TCP 1433
and UDP 1434
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 8 of 10
Computer Hardware Specifications for
Workstations, Clients, and Servers
Special Notes
1. This is provided as a guide only.
2. The PC configuration must be listed in the Microsoft Windows Marketplace Tested Products List
Hardware section for each respective operating system. If your PC hardware is not tested, then
the system may not work with the supported operating system.
3. The software runs on systems with sufficient random access memory (RAM) installed.
Depending on the usage of the system and the desired data throughput, those systems may not
exhibit acceptable performance.
4. In all cases, an appropriate amount of virtual memory should be configured.
5. Some scheduled or background processes like virus checking or defragmenting may cause
instrument communication or other performance problems. To avoid these kinds of problems it
is required to disable any scheduled events and minimize or eliminate any background processes.
Table 6. Recommended Minimum PC
Specification
Description
Minimum
Recommended
(if applicable)
Comments
(if applicable)
Processor type & speed
3 GHz
Quad Core
RAM
4 GB (2 GB for Microsoft
Windows 7)
>4GB is recommended
Internal
Storage/devices/media
DVD-ROM Drive
Screen Resolution
Super VGA
800 x 600
>Super VGA
Video Graphics Adapter
16-bit colors, 1MB video RAM
Printing devices
Default Printer
No default printer could result
in reporting and other errors.
Pointing devices
Computer Mouse
Microsoft Compatible
Interface
USB 2.0 or greater
Required for Cary 60
instrument communication
Hard Disk
250 GB
>250 GB is recommended
LAN
100/1000 MBIT
Required for network
connectivity
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 9 of 10
Other Requirements
1. Important web links
Microsoft Hardware Compatibility Lists
http://www.microsoft.com/whdc/hcl/default.mspx
Links to specific O/S fixes, updates needed
http://support.microsoft.com/
2. For the Cary 60 there is no need to manually load the firmware onto the Cary 60 as this is
automatically done once the instrument is connected to the Cary WinUV software. This means
that the Cary 60 will always have the appropriate version of firmware that was used/tested with
the software.
3. Cary 50 is not tested or supported for this version of Cary WinUV
4. Cary WinUV Pharma for this release uses Microsoft SQL Server 2014 Express Edition and
Microsoft .NET Framework 3.5 or 4.5.1 (if they are not already installed on your computer).
Other versions of SQL Server may work but have not been tested or validated by Agilent.
5. The Software Status Bulletin, SSB, contain other important information for this release of Cary
WinUV.
6. For addition important information please read the Release Notes that come with your software.
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 10 of 10
Important Customer Web Links
❑ For additional information about our solutions, please visit our web site at
http://www.chem.agilent.com/en-US/Pages/HomePage.aspx
❑ Need to get information on your product?
Literature Library - http://www.agilent.com/chem/library
❑ Need to know more?
Customer Education – http://www.agilent.com/chem/education
❑ Need technical support, FAQs? – http://www.agilent.com/chem/techsupp
❑ Need supplies? – http://www.agilent.com/chem/supplies
Document part number: G6860-90011
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Agilent Cary WinUV Pharma Revision 5.1.3 – Site
Preparation Checklist
Issued: 12-April-2019, Revision: A.00.01
Copyright 2019
Agilent Technologies
Page 1 of 1
Do not include this section in the PDF version.
Print only the checklist for the PDF. Do not include this page. This page is NOT intended for customer
viewing. See the guidance instructions at the end of the template for more information.
Document Control Logs
Revision Log
Revision
Date
Reason For Update
Rev. A.00.01 12-April-2019
First release for Cary WinUV 5.1.3.1242
Approval Log
Revision
Approver
Title of Approver
Rev. A.00.01 Dennis Toce
Product Support Engineer
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