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在规范的 GxP 环境中维护数据完整性

符合 FDA Part 11 关于合规软件的验证流程

SoftMax® Pro 7.1.2 GxP 软件是可实现完全符合 FDA 21 CFR 第 11 部分的最新、最安全的软件,它具备简化的工作流程,可确保数据完整性。每个步骤都经过优化,以简化分析流程和缩短报告时间,支持我们的微孔板读板机。

我们专业的技术团队将会协助您设置科研或企业版软件,利用我们的验证文件来提供 IQ OQ 服务,充分保障您微孔板读板机的合规性。重要数据的隐私和安全完善机制完全符合 GDPR 法规的最新要求。

请参阅 SoftMax Pro GxP 合规软件如何符合 21 CFR Part 11 和欧盟 GMP Annex /11 要求。

  • 追踪并记录所有变更

    追踪并记录所有变更

    系统审计追踪功能可记录所有信息的变更,包括日期和时间、用户名、用户 ID、评述、签名信息和检测结果。

  • 保持数据完整性

    保持数据完整性

    采用无纸化文档形式,系统通过控制电子签名和文档工作流程来维护数据完整性。项目团队可以在受控环境中追踪文档的创建、审核、发布和使用情况。

SoftMax Pro 7.1GxP 企业版软件

GxP 合规性软件功能

  • 实验步骤 图标

    Windows 活动目录

    在 Windows 活动目录中或通过 GxP Admin 软件进行用户管理,简化了对密码重置和更改周期的定义,降低了实验人员及 IT 的工作量。

  • 改进功能 图标

    改进自动保存功能

    实验前必须先将新文件保存才能对其进行修改,并且在检测前后文件会自动保存,以免数据丢失。

  • 改进签名 图标

    改进签名流程

    针对每个文件,用户均可添加评述并签名,保证其数据完整性。

  • 项目 图标

    定义项目

    创建项目团队,用户可以被分配到不同项目中使其具有不同的角色,但不能在同一个项目中具有多种角色。

  • 角色和权限 图标

    角色和权限

    根据每个项目对角色给予相应的权限分配,这种结构方式具有更稳定、更科学、更合规的优势。科学家、实验室管理员和实验室技术员这三种预定义角色适合最新文档发布的工作流程,从而让新用户能够快速上手。

  • 验证 图标

    数据自动导出功能

    数据导出至数据库外的位置,提供各种文件格式以支持导入到其他应用系统中,如实验室信息管理系统 (LIMS) 或科学数据管理系统 (SDMS)。支持 XML,以实现数据导出和自动导出。

经验证的 GxP 解决方案可确保数据完整性和合规性

我们为 GMP/GLP 实验室提供一整套经过验证的合规性解决方案,可以帮助您快速、自信地建立合规实验室。

  • 一流的微孔板读板机和洗板机可支持您的所有实验需求
  • IQ/OQ/PM 服务以数字化和合规格式保存仪器记录
  • 软件安装服务可验证并记录所需的组件是否按操作规范安装
  • 软件验证服务支持美国食品药品监督管理局 (FDA) 21 CFR Part 11 指南
  • 采用可追溯的验证板来检验您的微孔板读板机性能,帮助您得到可靠结果
适用于 GMP-GLP 实验室的 GxP 合规性解决方案

 

SoftMax Pro GxP 软件的应用

SoftMax Pro GxP 软件的技术参数和可选配置

 

温馨提示:

  • 为了防止数据丢失,请关闭硬盘、CPU 和 USB 接口的所有睡眠和休眠设置
  • 禁用 Windows 自动更新
  • 在软件不使用仪器时,手动更新 Windows;这些选项可在 Windows 控制面板中启用

注:不再支持在 Windows XP 操作系统上安装和使用 SoftMax Pro 软件。软件未在 Windows XP 上测试或验证。

SoftMax Pro GxP 软件的资源

报告内容
视频和网络研讨会
在规范的 GxP 环境中维护数据完整性

在规范的 GxP 环境中维护数据完整性

第 5 周视频略缩图

微孔板读板机的都市神话:读取-复制-粘贴-分析。重复...... 听起来很熟悉?

第 4 周视频略缩图

微孔板读板机的都市神话:超越基础 - 实时、分辨时间和转移能量

第 3 周视频略缩图

微孔板读板机的都市神话:“优化?但手册上说达到 490 nm 我就应该高兴了!”

 第 1 周视频略缩图

微孔板读板机的都市神话:OD、RFU 或 RLU - 它们究竟是什么,还有为什么越大并不总是越好!

第 2 周视频略缩图

微孔板读板机的都市神话:哪一款微孔板读板机?决策很重要,以及如何减少困惑!

适用于 GMP-GLP 实验室的 GxP 合规性解决方案

适用于 GMP/GLP 实验室的 GxP 合规性解决方案

全套软件和验证工具

适用于微孔板读板机的全套软件和验证工具如何能帮助 GMP/GLP 实验室符合 FDA 数据完整性指南

SoftMax Pro 7.1GxP 企业版软件

用于微孔读板机的SoftMax Pro GxP 软件验证流程

  • Citation
    Dated: Apr 23, 2021
    Publication Name: Nature Protocols

    Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays

    Virus neutralization assays measure neutralizing antibodies in serum and plasma, and the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of these antibodies for many viral diseases. We have developed procedures for the standard PRNT, microneutralization assay (MNA) and pseudotyped virus… View more

    Virus neutralization assays measure neutralizing antibodies in serum and plasma, and the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of these antibodies for many viral diseases. We have developed procedures for the standard PRNT, microneutralization assay (MNA) and pseudotyped virus neutralization assay (PNA) for severe acute respiratory syndrome coronavirus 2. The MNA offers advantages over the PRNT by reducing assay time, allowing increased throughput and reducing operator workload while remaining dependent upon the use of wild-type virus. This ensures that all severe acute respiratory syndrome coronavirus 2 antigens are present, but Biosafety Level 3 facilities are required. In addition to the advantages of MNA, PNA can be performed with lower biocontainment (Biosafety Level 2 facilities) and allows for further increases in throughput. For each new vaccine, it is critical to ensure good correlation of the neutralizing activity measured using PNA against the PRNT or MNA. These assays have been used in the development and licensure of the ChAdOx1 nCoV-19 (AstraZeneca; Oxford University) and Ad26.COV2.S (Janssen) coronavirus disease 2019 vaccines and are critical for demonstrating bioequivalence of future vaccines.

    Contributors: Kevin R. Bewley, Naomi S. Coombes, Luc Gagnon, Lorna McInroy, Natalie Baker, Imam Shaik, Julien R. St-Jean, Natalie St-Amant, Karen R. Buttigieg, Holly E. Humphries, Kerry J. Godwin, Emily Brunt, Lauren Allen, Stephanie Leung, Phillip J. Brown, Elizabeth J. Penn, Kelly Thomas, Greg Kulnis, Bassam Hallis, Miles Carroll, Simon Funnell & Sue Charlton  
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  • Citation
    Dated: Dec 15, 2020
    Publication Name: Vaccine

    Development and characterization of a standardized ELISA including a reference serum on each plate to detect antibodies induced by experimental malaria vaccines

    Enzyme linked immunosorbent assay (ELISA) has been widely used to measure antibody titers for evaluating the immunogenicity of a vaccine. However, there is as yet no generally accepted way of expressing the ELISA results in the case of experimental vaccines, since there is usually no uniform standard. Both end point and single dilution methods… View more

    Enzyme linked immunosorbent assay (ELISA) has been widely used to measure antibody titers for evaluating the immunogenicity of a vaccine. However, there is as yet no generally accepted way of expressing the ELISA results in the case of experimental vaccines, since there is usually no uniform standard. Both end point and single dilution methods have significant disadvantages. In this paper, we obtained reproducible data with fewer dilutions of samples by addition of serially diluted standard serum to each ELISA plate. Since this ELISA method gives reliable antibody titer with less labor than other methods, it can strongly support vaccine development.

    Contributors: Kazutoyo Miura, Andrew C. Orcutt, Olga V.Muratova, Louis H.Miller Allan, Saul, Carole A. Long  
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  • Citation
    Dated: Aug 19, 2020
    Publication Name: bioRxiv

    NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways 3 against SARS-CoV-2 challenge

    There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation. View more

    There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation.

    Contributors: Mimi Guebre-Xabier, Nita Patel, Jing-Hui Tian, Bin Zhou, Sonia Maciejewski, Kristal Lam, Alyse D. Portnoff, Michael J. Massare, Matthew B. Frieman, Pedro A. Piedra, Larry Ellingsworth, Gregory Glenn, Gale Smith  
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  • Citation
    Dated: Nov 28, 2019
    Publication Name: Springer

    Meeting technical challenges for protein characterization and surrogate equivalence studies that resulted from insecticidal protein co-expression in maize event MZIR098

    Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source. View more

    Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source.

    Contributors: Frederick S. Walters, Scott Young & Gerson Graser
     
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  • Citation
    Dated: Jul 12, 2019
    Publication Name: Nature

    Inside out: optimization of lipid nanoparticle formulations for exterior complexation and in vivo delivery of saRNA

    Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it… View more

    Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it requires a delivery vehicle for efficient cellular uptake and degradation protection.

    Contributors: Anna K. Blakney, Paul F. McKay, Bárbara Ibarzo Yus, Yoann Aldon & Robin J. Shattock
     
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  • Citation
    Dated: Oct 01, 2018
    Publication Name: Crop Protection

    Identification and characterization of abamectin resistance in Tetranychus urticae Koch populations from greenhouses in Turkey

    The two-spotted spider mite, Tetranychus urticae Koch is one of the most serious pests in greenhouses and has developed high resistance to many classes of acaricides rapidly. Three T. urticae populations were collected from vegetable greenhouses in Antalya and Muğla, Turkey. These populations showed high resistance levels to abamectin ranging… View more

    The two-spotted spider mite, Tetranychus urticae Koch is one of the most serious pests in greenhouses and has developed high resistance to many classes of acaricides rapidly. Three T. urticae populations were collected from vegetable greenhouses in Antalya and Muğla, Turkey. These populations showed high resistance levels to abamectin ranging between 223 and 404 fold compared to a susceptible population. The interaction of some synergists (piperonyl butoxide; PBO, diethyl maleate; DEM and S-benzyl O,O-diisopropyl phosphorothioate; IBP) with abamectin was analyzed showing possible implication of esterases in resistances in the three populations studied. The activities of esterase, glutathione S-transferase (GST) and cytochrome P450 (p450) was determined using α-naphthyl acetate, 1-chloro-2,4 dinitrobenzene (CDNB) and 7-ethoxycoumarin (7-EC) as substrates, respectively. In all field populations, esterase, glutathione S-transferase and P450 activities were higher, when compared to the susceptible population (GSS). The presence of known abamectin resistance target site mutations (G314D and G326E) on the glutamate gated chloride channels was also examined. However, no target site–resistance mutation was detected in all three populations. According to our results, detoxification enzymes, but no target site intensivity seem to play role in abamectin resistance in field T. urticae populations from Turkey.

    Contributors: Naciye Sena Çağatay, Pauline Menault, Maria Riga, John Vontas, Recep Ay  
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  • Citation
    Dated: Apr 04, 2001
    Publication Name: Journal of Investigative Dermatology

    An Alternative Approach to Depigmentation by Soybean Extracts via Inhibition of the PAR-2 Pathway

    The protease-activated receptor 2, expressed on keratinocytes but not on melanocytes, has been ascribed functional importance in the regulation of pigmentation by phagocytosis of melanosomes. Inhibition of protease-activated receptor 2 activation by synthetic serine protease inhibitors requires keratinocyte-melanocyte contact and results in… View more

    The protease-activated receptor 2, expressed on keratinocytes but not on melanocytes, has been ascribed functional importance in the regulation of pigmentation by phagocytosis of melanosomes. Inhibition of protease-activated receptor 2 activation by synthetic serine protease inhibitors requires keratinocyte-melanocyte contact and results in depigmentation of the dark skinned Yucatan swine, suggesting a new class of depigmenting mechanism and agents. We therefore examined natural agents that could exert their effect via the protease-activated receptor 2 pathway. Here we show that soymilk and the soybean-derived serine protease inhibitors soybean trypsin inhibitor and Bowman-Birk inhibitor inhibit protease-activated receptor 2 cleavage, affect cytoskeletal and cell surface organization, and reduce keratinocyte phagocytosis. The depigmenting activity of these agents and their capability to prevent ultraviolet-induced pigmentation are demonstrated both in vitro and in vivo. These results imply that inhibition of the protease-activated receptor 2 pathway by soymilk may be used as a natural alternative to skin lightening.

    Contributors: Christine Paine, Elizabeth Sharlow, Frank Liebel, Magdalena Eisinger, StanleyShapiro, MiriSeiberg  
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软件和安装服务

SoftMax® Pro GxP 软件:兼容 Windows 10

最新版本的 SoftMax Pro 7 GxP 软件套件包括:3 次软件安装(每个用户许可)、GxP 管理软件、软件 IQ/OQ 验证包 DVD、用户许可证、合格证书

单台计算机设置 多台计算机设置
部件号:SMP7X GXP 单台计算机 * 部件号:SMP7X GXP 服务器 *
安装服务
部件号:SMPGXP-INSTALL1COMP-OS ** 部件号:SMPGXP-INSTALLSVR-OS **
部件号:SMPGXP-INSTALLADVSVR-OS(对于定制服务器安装)
额外用户许可购买
部件号:SMP GXP ADD 部件号:SMP GXP SVR ADD
*需要购买至少 3 个许可
**仅适用于初次购买

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