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SoftMax Pro GxP
合规软件
SoftMax Pro GxP
合规软件

通过全套验证工具,符合 GMP/GLP 实验室的监管要求
符合 FDA 21 CFR 第 11 部分和 EudraLex 附件 11 针对软件验证的要求
SoftMax® Pro 7.1.2 GxP 软件是我们最新、最安全的一款软件,可实现完全符合 FDA 21 CFR 第 11 部分和 EudraLex 附件 11 要求,在保证数据完整性的同时还简化了工作流程。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。
了解 SoftMax Pro GxP 合规性软件如何符合 21 CFR 第 11 部分和欧盟 GMP 附件 11 的要求。
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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。
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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
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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。
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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。
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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。
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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。
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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。
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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。
满怀信心地确保数据完整性和合规性
我们提供了一整套经证明的 GMP/GLP 实验室合规性解决方案,可以帮助您快速、可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 FDA 21 CFR 第 11 部分和 EudraLex 附件 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

最新资源
SoftMax Pro 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
彩页
Support Plans for SoftMax Pro GxP Software
SoftMax Pro GxP 软件的支持计划
我们的客户支持团队是有关软件常见问题和任何事件报告的第一联系人。
由多区域团队......提供支持
宣传页
Sharing data between users has never been more secure
在用户之间以非常安全的方式共享数据
我们的 SoftMax® Pro GxP 软件套件可以从单台计算机扩展到全球网络环境。我们的专业服务团队将携手您的信息技术 (IT) 团队,以计划并……
电子书
The Ultimate Guide to Microplate Reader Solutions
微孔板读板机解决方案的最终指南
评价微孔板读板机的优劣并不复杂,首先,请考虑您的应用需求。如果预算适中,专用于主要应用的单模式读板机……
博客
FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs
FDA 21 CFR 第 11 部分和监管合规性在 GMP 和 GLP 实验室中的重要性
《美国联邦法规》在标题 21 下所述的食品和药品法规以及欧盟的 EudraLex 附件 11 对于确保安全......至关重要
宣传页
SoftMax Pro 7.1.2 GxP Software FDA guidance
SoftMax Pro 7.1.2 GxP 软件 FDA 指南
SoftMax® Pro 7.1.2 GxP 软件是可帮助您实现完全符合 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…宣传页
SMPCare GxP Support Plans
SMPCare GxP 支持计划
获得由最了解我们的微孔板读板机和 SoftMax® Pro GxP 软件的专家提供的远程博士级技术支持。仅 Molecular Devices SMPCare 可提供一站式支持…
白皮书
GxP regulated industry assessments of SoftMax Pro Software
SoftMax Pro 软件的 GxP 规范行业评估
本文件概述了对 21 CFR 第 11 部分以及 EudraLex 附录 11 的引用,及其在 SoftMax® Pro GxP 数据采集和分析软件于规范…下的实施中的应用。
白皮书
GxP regulated industry assessments of microplate readers
微孔板读板机的 GxP 规范行业评估
本文件概述了出于评估 Molecular Devices 微孔板读板机在规范环境下的实施而对 21 CFR 第 58、211 和 820 部分以及 EudraLex 附录 15 的引用…
宣传页
Instrument validation services
仪器验证服务
安装、操作资格、预防性维护
确保您的 Molecular Devices 微孔板读板机和洗板机持续合规,并准备好......以供审查彩页
GxP compliance solutions for GMP/GLP labs
适用于 GMP/GLP 实验室的 GxP 合规性解决方案
凭借微孔板检测系统和软件,Molecular Devices 成为综合合规性解决方案领域的领导者。通过结合验证服务和支持,我们的解决方案可......
信息图表
Streamline your compliance journey in GMP/GLP labs
简化您的 GMP/GLP 实验室合规历程
针对微孔板读板机和洗板机提供原始设备制造商 (OEM) 的全面操作认证和维修覆盖。
宣传页
Software validation service
软件验证服务
我们的 SoftMax® Pro GxP 软件现场验证服务支持 FDA 21 CFR Part 11 指南,并由我们经认证的现场服务工程师 (FSE) 进行。......中的每一步
宣传页
Service plans to maximize your productivity
可最大化您生产力的服务计划
各仪器的功能水平在其整个使用寿命周期内都会不断发展—随着实验室环境、检测条件、使用情况、在实验工作流程中的作用......而变化
宣传页
SoftMax Pro 7.1.2 GxP Software Suite - Purchase Guide
SoftMax Pro 7.1.2 GxP 软件套件——选购指南
SoftMax® Pro 7.1.2 GxP 软件套件可以从单台计算机扩大到多台计算机的网络环境。咨询您的 Molecular Devices 代表,并…
宣传页
SoftMax Pro 7.1.2 GxP Software - Comparison Sheet
SoftMax Pro 7.1.2 GxP 软件——对比表
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。每一个步骤都…
文献
Molecular Devices introduces enterprise-level SoftMax Pro 7.1 GxP Software
Molecular Devices 推出了企业级 SoftMax Pro 7.1 GxP 软件
基于当前业内领先的数据采集和分析软件,SoftMax Pro 7.1 GxP 软件可扩展其系统审计追踪功能,包括日期和时间戳;……
彩页
SoftMax Pro 7.1.2 GxP Data Acquisition and Analysis Software
SoftMax Pro 7.1.2 GxP 数据采集和分析软件
在 GMP/GLP 实验室中使用全套验证方案和工具以符合 FDA 要求。
电子书
Software compliance for GMP/GLP labs
GMP/GLP 实验室的软件合规性
SoftMax® Pro 7.1.2 GxP 软件是我们可帮助您实现完全符合 FDA 21 CFR 第 11 部分的最安全的软件,它具备简化的工作流程,可确保数据完整性。每一个步骤都…...
产品单页
Software Validation Package
软件验证包
对于在 GLP 或 GMP 实验室工作的研究人员,SoftMax® Pro 软件验证包可提供最全面的文件记录和工具,从而验证 GxP......
产品单页
SpectraTest Validation Packages
SpectraTest 验证包
多年来,Molecular Devices 的微孔板读板机旨在提供一致性能。在符合最佳做法的同时,读板机性能还应经过验证......
产品单页
SoftMax Pro 7.1.2 GxP Software
SoftMax Pro 7.1.2 GxP 软件
SoftMax Pro 7.1.2 GxP 采集和分析软件适用于合规实验室中的微孔板读板机。


在规范的 GxP 环境中维护数据完整性

适用于 GMP/GLP 实验室的 GxP 合规性解决方案

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
Number of Citations*: 76
Latest Citations: For a complete list, please click here .
*Source: https://scholar.google.com/
- Dated: Apr 23, 2021Publication 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 moreVirus 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
Go to article - Dated: Dec 15, 2020Publication 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 moreEnzyme 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
Go to article - Dated: Aug 19, 2020Publication 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 moreThere 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
Go to article - Dated: Nov 28, 2019Publication 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 moreSafety 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.
- Dated: Jul 12, 2019Publication 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 moreSelf-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
Go to article - Dated: Oct 01, 2018Publication 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 moreThe 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.
- Dated: Apr 04, 2001Publication 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 moreThe 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
Go to article
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 |