What is gxp software
[PDF File] GxP compliance in cloud infrastructure - KPMG
https://assets.kpmg.com/content/dam/kpmg/in/pdf/2022/08/gxp-compliance-in-cloud-it-infrastructure.pdf
3. Compliance risks in cloud adoption. Life sciences organisations operating in GxP areas like research and development are still hesitant in embracing cloud technology. However, implementation of adequate controls and compliance checkpoints can mitigate data integrity and security risks and help stay compliant.
[PDF File] SoftMax Pro 7 GxP企业版软件
https://www.moleculardevices.com/sites/default/files/zh/assets/data-sheets/br/softmax-pro-gxp-software.pdf
SoftMax® Pro 7 GxP 是我们推出的第四代企业版软件并带有合规工具. 结合了超过1个世纪的开发经验和100多位相关领域和内部人员对硬件、应用和数据分析的透彻理解. 2004年至今,安装超过160,000个企业版软件账号. 荣获全球最大50家制药公司“最满意企业版软件 ”称号 ...
[PDF File] GxP Multi Computer Installation Guide - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/user-guide/br/softmax-pro-gxp-multi-computer-installation-guide-v7-1-1.pdf
Insert the SoftMax Pro 7.1.1 GxP Compliance Software Suite installation DVD into the computer DVD drive or use alternative media. Locate and double-click the SoftMax Pro 7.1.1 GxP - Multi Computer Installation Components.msi file to start the install. On the Welcome page: Click Next.
[PDF File] Software Validation Test Suite - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/flyer/br/software-validation-service.pdf
Our SoftMax Pro GxP Software Validation Test Suite provides the most comprehensive documentation available to validate GxP functionality that ensures data integrity and compliance to FDA 21 CFR Part 11 . and EudraLex Annex 11 and Annex 15. Each step in the process will be carefully planned and executed. Software Validation Test Suite:
[PDF File] SOCET GXP | Brochure
https://www.geospatialexploitationproducts.com/wp-content/uploads/2023/10/GXP-Brochure__SOCET-GXP.pdf
SOCET GXP software is an advanced geospatial intelligence solution that. utilizes imagery from satellite and aerial sources to identify, analyze, and extract. ground features, allowing for rapid product creation. Image analysis, advanced. photogrammetric techniques, remote sensing, and feature collection workflows.
[PDF File] SoftMax Pro 5 Software - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/brochures/br/softmax-pro-5-software.pdf
Simple and Customizable. Using SoftMax Pro 5 Software is as easy as 1, 2, 3! 1. Turn on the instrument and launch SoftMax Pro 5 Software. The software identifies the instrument and displays only appropriate control options. 2. Open one of the 120+ included protocols and enter template data. 3. Press the Read button, save the file, and print out ...
[PDF File] GxP Admin Software Version 2.1 Primary Administrator …
https://www.moleculardevices.com/sites/default/files/en/assets/user-guide/br/gxp-admin-software-v2-1-1.pdf
GxP Admin 2.1 to preserve license codes and user permission templates. GxP Admin Software Version 2.1.1 Software Release Notes Introduction The GxP Admin Software version 2.1.1 is a minor update release. The following are the change incorporated in this update as compared to version 2.1, the last general release of the GxP Admin Software.
[PDF File] DATA SHEET SoftMax Pro GxP Software - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/data-sheets/br/softmax-pro-gxp-software.pdf
SoftMax® Pro GxP Software is our latest generation software that supports 21 CFR Part 11 and Annex 11 compliance for GMP/GLP regulated labs. Satisfied customers include all 50 of the top 50 global pharmaceutical companies. Our global field and development teams have broad expertise in laboratory equipment, applications, and analysis.
[PDF File] SMPCare GxP Support Plans - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/flyer/br/smpcare-gxp-support-plans.pdf
SMPCare GxP Support Plans Get remote PhD level technical support from the experts that know our microplate readers and SoftMax® Pro GxP Software best. Only Molecular Devices SMPCare provides one-stop support from experts who can . resolve most issues in a single call. Additionally, we have consultative services to help with protocol and
[PDF File] GxP Toolkit in ZEISS ZEN core
https://asset-downloads.zeiss.com/catalogs/download/mic/31f45d9e-db77-48b8-8dc2-92ac9c4e2908/EN_product-flyer_GxP-Module-for-ZEN-2-core.pdf
Ready Software Module for Regulated Industries Imaging Software Simplified ZEN core is a powerful, yet easy to use, microscopy imaging software. You can set up individual workflows, from image acquisition all the way to a final report including analysis results. The user interface for the workflow is adaptive. That means, you can tailor it to your
[PDF File] Risk-Based Approach to Change Management of Validated …
https://www.veeva.com/wp-content/uploads/2021/01/NA_Whitepaper-_Risk-based_Approach_to_Change_Management_of_Validated_GxP_Systems.pdf
the principles and methodology can be applied to a wide range of GxP systems. Introduction The evolving nature of the life sciences industry demands a nimble approach to the steady state management of validated systems. Validation of GxP systems is required to assure they are fit for intended use and compliant with applicable regulations.
[PDF File] GXP Software Solutions for Targeting - Geospatial …
https://www.geospatialexploitationproducts.com/wp-content/uploads/2020/10/GXP-Solutions-for-Targeting.pdf
Both SOCET GXP Multiports and GXP Webview Cesium® based viewers support multiple views, raw imagery with rigorous sensor modeling, and multi-source image manipulation. Americas. Tel 800 316 9643 gxpsales@baesystems.com. Asia. Tel +603 2191 3000 gxpsales.asia@baesystems.com. Australia and New Zealand.
[PDF File] Powered by the GXP Xplorer Platform - Geospatial …
https://www.geospatialexploitationproducts.com/wp-content/uploads/2021/01/GXP_Brochure_2019_WEB_GXP-Platform.pdf
GXP Fusion software is designed for Department of Defense, Intelligence Community, and Law Enforcement personnel with big data challenges who want to gain insights via identification of hidden relationships and patterns in large volumes of data. GXP Fusion capabilities empower the
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN …
https://picscheme.org/docview/3444
4.9 Computerised systems may simplistically be considered to exist as three main application types, i.e.: process control systems, data processing systems, (including data collection/capture) and data record/ storage systems. There may be links between these three types of system, described as ‘interfaces’.
[PDF File] SOCET GXP | Brochure - Geospatial eXploitation Products
https://www.geospatialexploitationproducts.com/wp-content/uploads/2021/01/GXP_2019_Brochure_Web_SOCET-GXP.pdf
SOCET GXP software is an advanced geospatial intelligence solution that utilizes imagery from satellite and aerial sources to identify, analyze, and extract ground features, allowing for rapid product creation. Image analysis, advanced photogrammetric techniques, remote sensing, and feature collection workflows are seamlessly combined into one ...
[PDF File] SoftMax Pro 6 Microplate Data Acquisition & Analysis …
https://www.moleculardevices.com/sites/default/files/en/assets/brochures/br/softmax-pro-6-microplate-data-acquisition-and-analysis-software.pdf
SoftMax Pro is capable of analyzing more than just standard microplate data. Acquisition and image-based data analysis may be done with the full set of SoftMax Pro analysis tools. Easily acquire and analyze images generated from the SpectraMax® MiniMaxTM Imaging Cytometer. View data in lab notebook format.
[PDF File] SoftMax Pro Data Acquisition and Analysis Software Release …
https://www.moleculardevices.com/sites/default/files/en/assets/user-guide/br/softmax-pro-release-notes-7-1-2.pdf
The SoftMax Pro Software version 7.0 is a major release. The following is a summary of the changes incorporated in this revision as compared to version 6.5.1, the last general release of the SoftMax Pro Software. To obtain a copy of the release notes for versions older than 7.0, contact technical support.
[PDF File] GxP Risk Assessment for Computerized Systems - Egnyte
https://www.egnyte.com/sites/default/files/2020-03/GxPWhitepaper-RiskAssessmentComputerizedSystems.pdf
Approach. In this assessment, we enumerate specific workflows that a computerized system may be involved with. Based on each workflow, we have pre-estimated a ‘risk score’ associated with each. The higher the score, the higher likelihood you will need to validate the requisite system. Some workflows have high risk and almost always need to ...
[PDF File] SoftMax Pro 7 Data Acquisition and Analysis Software - VWR
https://us.vwr.com/assetsvc/asset/en_US/id/27822370/contents/tds-softmax-pro-software.pdf
Optional hardware and software validation tools are designed to speed and simplify the validation process by making it easier to demonstrate compliance of data collection and analysis. Available tools include: • All-inclusive software validation package for SoftMax Pro GxP Software • Instructions and worksheets for
SoftMax Pro Software User Guide - VWR
https://us.vwr.com/assetsvc/asset/en_US/id/6819551/contents/softmax-pro-5-software
SoftMax Pro GxP software is a special release that includes full user and permission control and audit trail generation in addition to all the data collection and analysis features found in the Standard edition. With the audit trail features …
[PDF File] GxP Admin Software User Guide - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/user-guide/br/gxp-admin-user-guide-v3-0-1.pdf
To restore the GxP Admin Software database from a backup: Click or locate and double-click GxPAdminBackupTool.exe to display the GxP Admin Backup Tool dialog. In the Restore area, in the Restore From field, either enter the path to the location of the. backup file or click to display the Browse For Folder dialog.
[PDF File] GXP Platform - BAE Systems
https://www.baesystems.com/en-media/uploadFile/20210404053944/1434615914703.pdf
GXP Platform ™ Providing the foundation for development of the most ... Geospatial eXploitation Products (GXP®) GXP develops powerful software tools used to deliver highly accurate geospatial and intelligence data. Based in San Diego, Calif., GXP provides direct worldwide sales and support. In some areas, this is done in conjunction with
[PDF File] Software compliance for GMP/GLP labs | Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/brochures/br/software-compliance-for-gmp-glp-labs.pdf
SoftMax® Pro 7.1.2 GxP Software is our most secure software to help you achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers. Our global professional services team will partner with you to install single- or ...
[PDF File] SoftMax Pro GxP Software Suite - Purchase Guide
https://www.moleculardevices.com/sites/default/files/en/assets/flyer/br/softmax-pro-gxp-software-suite-purchase-guide.pdf
• GxP Admin Software—Database and security backend application that you install on a dedicated, centrally located server with . a static IP address. This server must be accessible to all computers that run the GxP Admin Portal Software and the SoftMax Pro . GxP Software. • GxP Admin Portal Software —The user interface that you use to ...
[PDF File] GxP Admin User Guide - Molecular Devices
https://www.moleculardevices.com/sites/default/files/en/assets/user-guide/br/gxp-admin.pdf
You use GxP Admin Software to create and maintain User Accounts (.edb) files. SoftMax Pro GxP Software uses these User Accounts files to regulate user access to SoftMax Pro GxP Software and to provide traceability and accountability in electronic records. SoftMax Pro GxP Software users can be linked to a User Accounts file in one of two ways:
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