蔡司 ZEN core GxP模块
实现显微镜软件可追溯工作流程的解决方案
保证显微镜操作过程安全合规
ZEN core成像软件中的GxP模块支持可追溯工作流程，与蔡司显微镜硬件和软件无缝衔接，能够满足具有监管要求的行业（如食品行业，药品行业等）的需求。
GxP模块可以协助：
- 质检经理获得可重复的检验结果，以及安全的测试过程；
- 测试工程师检验显微镜测试结果；
- 实验室管理人员记录显微镜操作过程；
- IT经理实现备份/数据恢复功能以及归档/数据库功能；
- 制药公司实施符合FDA 21 CFR Part 11要求的测试规范。
优势
审核（Audit Trail）
用户管理 /用户角色
![与作业模式功能相结合的用户管理]({"small":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_9752/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.s.1527042221947.png/user-management_gxp-module-zen2-core.png","large":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_9752/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.l.1527042221947.png/user-management_gxp-module-zen2-core.png","medium":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_9752/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.m.1527042221947.png/user-management_gxp-module-zen2-core.png","full":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_9752/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.f.1527042221947.png/user-management_gxp-module-zen2-core.png"} "与作业模式功能相结合的用户管理")
发布工作流程
![验证电子签名]({"small":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column/columnpar/visibilitycontainer/wrapperpar/image_ffb6/image.pic.s.1527042362057.png/electronic-signature-verification_gxp-module-zen2-core.png","large":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column/columnpar/visibilitycontainer/wrapperpar/image_ffb6/image.pic.l.1527042362057.png/electronic-signature-verification_gxp-module-zen2-core.png","medium":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column/columnpar/visibilitycontainer/wrapperpar/image_ffb6/image.pic.m.1527042362057.png/electronic-signature-verification_gxp-module-zen2-core.png","full":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column/columnpar/visibilitycontainer/wrapperpar/image_ffb6/image.pic.f.1527042362057.png/electronic-signature-verification_gxp-module-zen2-core.png"} "验证电子签名")
GxP使用定义好的步骤来发布工作流。使用校验和（checksum）及电子签名确保工作流一经发布就不可更改。
数据的校验和（checksum）保护
工作流程、作业模板和结果数据使用电子签名，并且之后的任何修改都会使用校验和（checksum）保护。
数据恢复
![备份和恢复功能]({"small":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.s.1544617385397.png/backup-and-restore.png","large":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.l.1544617385397.png/backup-and-restore.png","medium":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.m.1544617385397.png/backup-and-restore.png","full":"/microscopy/products/microscope-software/gxp/j/m/section_c800/sectionpar/column_control_1e15/column0/columnpar/visibilitycontainer_/wrapperpar/image_ffb6/image.pic.f.1544617385397.png/backup-and-restore.png"} "备份和恢复功能")
万一发生硬件故障，IT经理将受益于定期对软件的备份，以及软件提供的恢复功能，确保系统能快速回复到正常工作状态。
下载
ZEISS ZEN core
Software Suite for Connected Microscopy in Material Laboratories
页: 33
文件大小: 14957 kB
GxP Module in ZEISS ZEN core
Your Software Module for Regulated Industries.
页: 2
文件大小: 1029 kB
Application of GxP principles to routine metallography
ZEISS ZEN core Module GxP for auditability and data integrity in the metals industries
页: 15
文件大小: 5246 kB
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