SoftMax® Pro 7.1.2 GxP 软件是我们全新、较安全的一款软件,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,可简化分析流程和缩短报告时间,以此来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。
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。
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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。
科学海报
基因编辑使我们能够使用多种工具通过缺失、添加或其他修饰来操控脱氧核糖核酸 (DNA)。有许多有效的策略可进行这些修饰……
应用文章
制药领域对更快高通量细胞系开发和更佳筛选的需求增加,这就促使研究机构和公司自动化……
文献
制药行业处于一个受到高度监管的环境。出于充分的理由。随着潜在药物进入开发过程 – 从体外发现阶段到……
博客
SLAS 欧洲2022,举办了许多关于新兴主题前沿研究的会议,以及专注于如何构建和成功......的会议和小组讨论
博客
近几十年来,遗传工程和合成生物学方面的进展使得诸多突破性技术成为可能。细胞系开发的重要性需要荣誉......
宣传页
SoftMax Pro GxP 软件是我们全新、较安全的一款软件,可实现完全符合美国食品药品监督管理局 (FDA) 联邦法规 (CFR) 第 21 章第 11 部分和 EudraLex 附件 11 的要求,同时具备简化的工作流程以确保数据完整性……
彩页
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
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
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
《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 软件是可帮助您实现完全符合 FDA 21 CFR 第 11 部分的全新、较安全的软件
,它具备简化的工作流程,可确保数据完整性…
宣传页
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
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
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
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
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引领者。通过结合验证服务和支持,我们的解决方案可......
信息图表
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
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
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 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 软件是可实现完全符合 FDA 21 CFR 第 11 部分的全新、较安全的软件,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
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
在 GMP/GLP 实验室中使用全套验证方案和工具以符合 FDA 要求。
彩页
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
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
多年来,Molecular Devices 的微孔板读板机旨在提供一致性能。在符合理想做法的同时,读板机性能还应经过验证......
应用文章
在平行线分析 (PLA) 的帮助下,可分析生物检测。PLA 常用于比较剂量反应曲线,其中未直接测量......
产品单页
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
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.
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.
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.
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.
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.
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.
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.
SoftMax® Pro GxP 软件:兼容 Windows 10
全新版本的 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 份许可证 **仅适用于初次购买 |