1、EmpowerEnterprise验证方案Empower SystemsQT for SoftwareThis protocol document describes the process for performing the Installation Qualification (IQ) and Operational Qualification (OQ) for Waters Empower SystemsQT for Software, with or without Method Validation Manager (MVM) software.Evaluate before qu
2、alification beginsThe owners management must review this protocol, the Empower SystemsQT for Software release notes (part number 716003298), the Waters Qualification Overview (part number 715511111), and Empower 3 software release notes: Empower 3 (base) Release Notes (part number 715002704) Service
3、 Release 1 Release Notes (part number 716003450)To perform the qualification, you must be running Empower 3 Feature Release 1, minimum. Feature Release 1 Release Notes (part number 716003561) Feature Release 2 Release Notes (part number 716003923) Feature Release 3 Release Notes (part number 7160046
4、89)Identify the scope: Personal, Workgroup, or Enterprise Considerations for IQ or OQ execution: Execution for the Citrix server requires it to be listed as a node. If the Citrix server is not listed as a node, login to the Citrix server and launch Empower. In Nodes, create a new node using the exac
5、t name of the Citrix server. Ensure computer connection to a printer, however each node does not require printer access. Enable the Run Empower SQT privilege for your User Type. If intending to use Electronic Signatures, perform the following:o Enable the Sign Off Results 1 for your User Type.o Chec
6、k the Result Sign Off tab in System Policies for Valid Sign Off 1 Reasons. Determine if Default Strings for Result Signoff i Meanings and Result Sign off 2 Meanings can be created. Create、Pass and Fail default strings if possible.In the Qualification Overview document, ensure that these forms are co
7、mpleted: Qualification Approval Identification of Performers and ReviewersWCltrS 715G05185, Revision ATHE SCIENC OF Empower, Millennium, NuGenesis, The Science of Whats .Possible, and Waters are registered trademarks,and ApexTrack, LAC/E, and SystemsQT are trademarks of Waters Corporation.Citrix is
8、a registered trademark of Citrix Systems, Inc. AH other trademarks are the sole property of their respective owners.Copyright 2016 .Waters Corporation March 2016OverviewThe Empower SystemsQT for Software is specific to the Empower 3 FR1 and above releases. The Empower SystemsQT uses a wizard to run
9、the software IQ and OQ. The reports can be signed off electronically or printed. Reports that display the method parameters used may contain blank fields because the parameters may not be enabled or populated in the method.The data set used for IQ is a blank injection and is used to create the IQ re
10、port and allows for electronic signature. The IQ data set was collected for Empower 3 FR3.The data set used for internal standard calculations is identical to that used in Empower 2154, Empower 1154, or Millennium32 v3.2, v3.05.01, or v3.05.The data set used for external standard calculations is ide
11、ntical to that used in Empower 2154, Empower 1154, or Millennium32 v4.0 or v3.2.The data set used for the method validation manager is identical to that used in Empower 2154 FR 3.You need not enable ApexTrack integration if your organization uses traditional integration.Installation qualification (I
12、Q)The IQ represents the installation qualification process for a Waters Empower 3 Personal, Workgroup, Enterprise, or LAC/E32 module software system consisting of software and associated hardware components.The purpose of the IQ portion of the qualification is to confirm these conditions: Personal,
13、Workgroup, Enterprise, and/or LAC/E32 module software components are properly installed. Empower 3 software is properly installed. Empower 3 files you installed on the system are not corrupted and remain identical to the flies shipped from Waters. Any Empower 3 software options are properly installe
14、d. The name of the operating system, build number, and all service packs apply. The total number of Empower 3 named user licenses and system licenses for Workgroup and Enterprise. Any Empower 3 service packs are properly installed and verified.Software file verificationDuring installation of the Emp
15、ower 3 software, the software automatically runs a file verification utility, which verifies that the disk files shipped from Waters were not corrupted during Installation. The file used for the comparison is in EmpowerSCRIPTDIR.CKS.The file verification focuses on these file attributes: Cyclic Redu
16、ndancy Checksum (CRC) File size File date and time stampIf the file verification utility detects a change in any file, the installation is aborted. You can rerun the utility anytime, to requaiify the installation.Rule: The software does not overwrite the original CHECKSUM.TXT file each time you run
17、the Verify Files utility. Instead, each subsequent CHECKSUM.TXT file name is annotated with the date and time: for example, EmpowerSCRIPTChecksum_il.01.2010_12.23.41.txt.Operational qualification (OQ) for Empower SystemsQT for Software onlyEvaluate and determine if traditional integration or ApexTra
18、ck integration will be used when executing the OQ.Restore the appropriate projects based upon the integration chosen: Traditional Integration 一 Restore the Valid_OQl project ApexTrack Integration - Restore the Valid_OQl and Valid_OQApex projectsEnsure all appropriate projects are restored. If all of
19、 the projects (Valid_OQl, Valid_OQApex, and Valid_OQMVM) are not restored the following message will appear when making requests from the SQT wizard:It is not required to restore all the projects, only those appropriate. If the appropriate projects are restored, click、No and continue.The projects pr
20、ovided by Waters are limited to verifying and documenting the ability of Empower 3 software to perform these tasks: Restore projects Process standards Process unknowns Perform peak integration Perform quantification Perform calibration Generate a printed report or save a result to the database Notes
21、: When the ApexTrack Integration option is enabled and both the Vaiid_OQl and ValidOQApex projects are restored, the result sets for the Internal Std Sample Set and External Std Sample Set will be available in both projects when an OQ request is initiated. The reports contain an Integration Algorith
22、m field that indicates whether traditional or ApexTrack integration was used.Operational qualification for Empower SystemsQT for Software with Method Validation ManagerIf you activated the Empower SystemsQT for Software MVM qualification, the OQ uses the Valid_OQMVM project.The Valid_OQMVM project i
23、s provided by Waters and limited to verifying and documenting the ability of the Empower 3 Method Validation Manager to perform these tasks: Restoring a validation working type project. Generating statistical validation results for all validation tests. Ensuring the correct value is generated during
24、 validation processing. Ensure you restore the appropriate project folders for Empower 3 Feature Release 3.The report includes method validation results and protocol for these method validation tests: Linearity Linearity comparison LDL/LQL Specificity Accuracy Repeatability Reproducibility Intermedi
25、ate precision Intermediate precision DOE Robustness Stability Filter validation System precisionNode PropertiesThe SQT license enables additional tabs in the node properties: IQ Info and IQ/OQ.1. In Configuration Manager, select Nodes and then select a node to update its properties.2. Right-click pr
26、operties.3. Select the IQ Info tab. Identify the computer components associated with this software IQ in the spaces provided. When you complete the Computer Components form, compare the information entered on it with the purchase order for the Empower 3 software system. When you install software as
27、part of a reloading operation or software support plan upgrade, the purchase order is sometimes unavailable. In such a case, type RELOAD or UPGRADE on the Purchase Order Number line of the Computer Component for that client.4. Identify the documentation information required for qualification. When y
28、ou complete the documentation Information, identify each document as follows: If the document was received, select Yes. If the document was not received, select No. If the document has a revision, enter the revision. If the document is missing or not applicable, enter that information in the comment
29、s.5. Identify the components and peripherals of the Empower 3 system associated with this software IQ. When you complete the Configuring the Computer and Peripherals section, select either Installed or、N/A on the line corresponding to each device you install. If any comments apply to the installatio
30、n, enter them in the comments section.Note: If the Empower 3 system was purchased from Waters, you need not verify the configuration. Instead, in the configuring components and peripherals section, certify that the computer was configured at the factory by selecting Yes.6. Click OK.Running the Empow
31、er SystemsQT for SoftwareTo run the Empower SystemsQT for Software, perform these tasks:1. Log in to Empower, using the Pro interface, as a designated user with a full name. Do not log in as one of the default users.2. Before the qualification begins, ensure these conditions are met:a. The owners ma
32、nagement reviewed the Qualification Overview, this protocol, and any applicable release notes.b. The Qualification Protocol Approval Form 1-1 and the Identifying Performers and Reviewers Form 1-2 (both available m the Qualification Overview document) are completed and signed.3. From the Empower Pro window, click Configure System, and then select Projects.
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