Agilent OL ICM - Comprehensive System Validation Service Data Sheet
Contents
1. Agilent OL Instrument Control Manager Comprehensive System Validation Service Agilent OL Installation Qualification Service The Agilent OL Installation Qualification IQ Service validates that your system as purchased is installed as designed and specified The Agilent OL IQ Service documents that your system has been properly installed into your environment and that this environment is suitable for the proper operation of the system The purpose of the IQ is to ensure the following The products that you have purchased from Agilent Technologies have been received as purchased Your environment meets the environmental specifications as set by Agilent Technologies The software that you purchased is completely installed on the server and client computers The Agilent OL system functions properly in your environment All the equipment hardware and software that you purchased is documented Deliverables Agilent Technologies will prepare an IQ document that includes the configuration of the system being implemented and send it in electronic form for approval prior to the qualification As the customer you will review and approve the IQ protocol as assembled by Agilent Technologies Analytical Validation Services This protocol will reflect the current Agilent Technologies qualification procedures for the product Agilent personnel will execute an IQ with the predefined protocol prepared by Agilent Technologies Th2. an OQ for the server or servers and one client computer covered by the installation with the predefined protocol prepared by Agilent Technologies The OQ tests to ensure the components of the Agilent OL system are operating properly including depending on configuration e ECM e BPM e ECM Options e ICM e Instrument control options e ECM Desktop Client e Remediation Services e ECM Print Services e Agilent personnel will deliver the executed OQ documents to the customer upon completion of execution for review and approval All data collected by the Agilent representative will be signed and dated Acceptance criteria Acceptance of the entire Agilent OL OQ Service is complete when the OQ documentation is reviewed and signed by both responsible parties Limitations and assumptions The customer assumes responsibility for the review acceptance archiving and security of the delivered record of qualification Any requested modification to the OQ will be considered a change order to the project The Agilent OQ Service covers once instance of an Agilent OL system such as the Validation instance Additional instances can be validated for an extra fee The OQ for the acceptance and production systems covers one client computer Additional client computers can be validated for an extra fee Screen captures are not included in the OQ execution Customer obligations Responsible for maintaining all hardware software associate
3. aptation or translation without prior written permission is prohibited except as allowed under the copyright laws Published February 16 2007 Publication Number 5989 6359EN ra a Agilent Technologies
4. d with this system under change control management Agilent Instrument Controller 10 00 Service Agilent Technologies will install and run the IQ OQ for an Agilent Instrument Controller AIC using Agilent approved protocols This effort takes place on a pre defined schedule Deliverables e Installation and configuration of AICs For the number of instruments supported per AIC see the support matrix e An IQ AIC IQ report and OQ communications test of each AIC e Multiple onsite trips can be included for a phased implementation of the AIC instrument qualification in your laboratory This is based upon the project plan and services purchased Acceptance criteria Acceptance of the AIC IQ OQ Service is based upon successful execution of the AIC IQ and OQ Limitations and assumptions e All AICs will be installed and configured during one visit e AICs must be qualified in batches of at least five e The OQ communications test will be performed by Agilent personnel only for instruments made available at the time of the visit The customer performs the communications test for any instrument connections not performed by Agilent personnel at the time of the AIC qualification Customer obligations e Onsite visits beyond the planned seven visits require a change order e Rescheduling of services is per terms and conditions available on request Copyright 2007 Agilent Technologies All Rights Reserved Reproduction ad
5. e IQ tests to ensure the components of the Agilent OL system are installed properly including depending upon your specific configuration e Enterprise Content Management ECM e Business Process Management BPM e ECM Options e Instrument Control Manager ICM e Instrument control options e One ECM Desktop Client e Remediation Services e ECM Print Services Agilent Technologies will deliver the executed IQ paper document upon completion of the execution for final review and approval All data collected by the Agilent representative will be signed and dated as per the protocol instructions Acceptance criteria Acceptance of the entire Agilent OL IQ Service is complete when the IQ documentation is reviewed and signed by both responsible parties Limitations and assumptions The customer assumes responsibility for the review acceptance archiving and security of the delivered record of qualification Any requested modification to the IQ will be considered a change order to the project The customer plans to purchase IQ for the acceptance and production systems The Agilent IQ Service covers once instance of an Agilent OL system such as the Validation instance Additional instances can be validated for an extra fee The IQ for the acceptance and production systems covers one client computer Additional client computers can be validated for an extra fee Screen captures are not included in the IQ execution Custome
6. r obligations Responsible for maintaining all hardware software associated with this system under change control management Agilent OL Operational Qualification Service The Agilent OL Operational Qualification OQ Service validates that your system as purchased meets functional specifications as designed The Agilent OL OQ Service documents that your system both hardware and software as purchased meets functional specifications and performs as intended throughout representative or anticipated operating ranges The OQ protocol was developed using the methodology outlined below e The server and client functions were defined in advance e Test cases were developed with expected results and acceptance criteria by Agilent Technologies e The OQ protocol is jointly approved prior to the execution of the protocol e A certified Agilent representative will execute the tests e The results of each test will be compared with the expected results and the acceptance criteria e The resulting document will be jointly approved by the customer and Agilent Technologies Deliverables e Agilent Technologies will prepare an OQ document that is tailored to the configuration of the system being implemented e As the customer you will review and approve the OQ protocol as assembled by Agilent Technologies Analytical Validation Services This protocol will reflect the current OQ procedures for the product e Agilent personnel will execute
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Agilent OL ICM Comprehensive System Validation Service Data Sheet