环境参数分布试验确认 维萨拉提供全面的参数分布试验确认解决方案,帮助您遵守 GDP (良好分销规范)法规,例如欧盟 GDP (2013/C 343/01) 和美国药典 36 版第 <1079> 以及即将出台的第 <1083 章>. 环境参数分布试验确认(在存储人用和研究药品的区域必须完成)由药品生产商、储存设施、批发分销商和 GxP 供应链中的其他利益相关者进行。查看维萨拉 IQOQ 协议样本 (PDF)。 观看系统概述视频 请参阅设备选择指南 查看库里的GxP监管条文 维萨拉环境分布试验确认包括: 分布试验套件:维萨拉数据记录仪,用于采集测量数据的 vLog 软件,以及根据联邦法规第 21 章第 11 款和附录 11 验证软件的 vLog IQ/OQ 协议。 世界级 参数分布试验服务 用于描述冷藏库、冷冻库、冷冻间、仓库、储藏区、配送中心、恒温箱或稳定室的温度和相对湿度动态。(服务范围包括欧洲、日本和中国) 可选的 自定义校准 以行业最佳准确性为目标 参数分布试验确认要求更加严格,提高了法规期望 过去几年中,良好分销规范(GDP)增加了监管重点。在很大程度上,是由加拿大卫生部门 (GUI-0069, 2011) 发起的,该机构是第一个提到温度分布试验的监管机构。全球监管机构很快就重申了这一方向,其中包括: 印度 CDSCO(中央药品标准控制组织) 中国国家药监局(中国食品与药品管理局) 欧洲 EMA(欧洲药品管理局) 这些组织先后发布了新的或更新的指导原则和文件。美国随后更新了美国药典第< 1079 >章“药品良好分销规范”。此后不久,出现了几个提供具体说明的指南。例如,国际制药工程学会的冷链管理出版物就分布试验确认传感器的放置提出了建议。美国注射剂协会的技术报告 58 讨论了如何进行与 GDP 相关的风险评估。药品检验合作计划发布了自己的 GDP 指南,紧扣欧盟的 GDP 法规。这是向全球标准化迈出的重要一步,因为 PIC/S 目前拥有 40 多个参与国。 温控供应链的行业变革迫切需要指导 同时,分销活动也在不断发展,分销链日益国际化。然而,这导致温度偏差风险增加。若得以良好执行,环境分布试验确认就是评估和消除偏差风险的理想方法。但是,良好执行分布试验确认都包括什么呢? 首先,在任何规定的药品进入冷藏区、仓库和温度控制室之前,应该始终进行分布研究。分布试验要在有代表性的条件下进行。在实践中,这意味着在冬季和夏季进行季节性分布研究。另外,分布试验要包括空载条件和装载条件。对一个区域或室进行分布试验确认后,就要根据温度波动最大的位置布置监测传感器,这些位置通常称为热点和冷点。 验证原则带来客观的确认结果 环境分布试验确认的最终目标可以总结如下: 证明温度(和湿度(需要时))的一致性。 识别不合适的存储区域。 确定有代表性的监测点 记住,参数分布研究确认不限于固定地点。对于配送链中的温度控制车辆,根据上述基本原则进行原始温度分布试验确认:装载和空载状态下具有代表性的条件下,根据研究结果,将区域排除在存储位置之外或对其进行连续监测。 有关维萨拉环境参数分布试验确认解决方案的更多信息,请参阅我们的手册,或联系您当地的服务中心。 资源 欧盟良好分销规范 GDP (2013/C 343/01) 2013 年 11 月 5 日关于人用药品良好分销规范的指导原则 美国药典 36 版 – 第 <1179> 章药品良好存储和分销规范 美国药典 36 版 – 第 <1083> 章良好分销规范(将在未来发布) 联邦法规第 21 章第 11 款电子记录/电子签名 联邦法规第 21 章第 11 款电子记录/电子签名 GUI- 0069 药品贮运中的温度控制指南,2011 年。 CDSCO 生物制品良好分销规范指导原则,2012 年。 中国国家食品药品监督管理局药品经营质量管理规范(GSP),卫生部令第 90 号,2013 年。 ISPE 良好实践指南:冷链管理,2011 年。 PDA: 技术报告 58 - 温度受控销售风险管理,2012 年。 PIC/S 良好药品分销规范指南,2014 年。 进一步阅读 法国标准 AFNOR NFx15-140 澳大利亚标准 AS2853-1986 德国标准 DIN 12880。 存储区域温度分布试验,世卫组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。 温度控制存储区域的确认,世界卫生组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。 相关产品 DL1000-1400 温度记录仪 用于受控环境温度监测与温湿度参数分布研究 维萨拉 DL1000-1400 是一款高准确度温度数据记录仪。DL1000-1400... Read more VaiNet 无线接入点 AP10 针对无线监测 VaiNet 无线连接点 AP10 是一款无线网路硬件设备,针对维萨拉的专有无线技术:VaiNet。AP10 最多可将... Read more VaiNet 无线数据记录器 RFL100 针对无线温度与湿度监测 RFL 系列数据记录器采用维萨拉的专有 VaiNet... Read more Wi-Fi 数据记录仪 HMT140 用于监控温度、相对湿度、电流、电压与门开关传感器 维萨拉 HMT140... Read more 以太网记录器接口连接的 vNet 电源 用于将 DL 系列数据记录仪连接至网络 以太网记录器接口连接的 vNet 电源是网络连接的托架,它将 DL... Read more 温湿度数据记录仪 DL2000 用于监测温度、湿度,具有可选择的模拟输入 维萨拉 DL2000... Read more 验证参数分布研究套件 对于 GxP 环境下温度和湿度的确认 ... Read more vLog VL 软件 为验证/参数分布研究 GxP 环境 该 vLog... Read more viewLinc 应用程序编程接口 将 viewLinc 与现有系统集成 维萨拉 viewLinc 监测系统测量工业和监控 GxP... Read more 采用 VaiNet 技术的无线监测系统 长距离无线通信 Read more TMP115 宽量程温度探头 适用于要求严苛的温控环境 TMP115 温度探头采用铂电阻 RTD... Read more 维萨拉数据记录仪的电缆 维萨拉电缆用于将维萨拉数据记录仪连接至标准 USB 端口和标准 RS-232 系列端口。 Read more 相关案例 博客 | Dec 17, 2020 Q&A on cybersecurity for GxP monitoring systems Welcome to another video question and answer from our webinar: "Cybersecurity in your GxP monitoring system." In this video, our Senior GxP... 了解更多 成功案例 Keeping temperature and humidity conditions under control at the Jusélius Mausoleum The mausoleum of Sigrid Jusélius is a significant cultural site in Pori, Finland. The mausoleum, built in 1901-03, is a masterpiece of the arts... 了解更多 成功案例 Easy and accurate validation system ensures competitive advantages to mapping service provider Since 1988, Performance Validation (PV) has provided validation, commissioning, and quality services to pharmaceutical, biotechnology and... 了解更多 博客 | Aug 14, 2020 Video Q&A: Guidance documents, references, and advice for warehouse mapping In this video, we answer questions we didn’t have time for during our June webinar “Continuous Mapping in Warehouses: Better Data, Better... 了解更多 博客 | Jul 14, 2020 Out-of-spec sensors, incubator hot/cold spots & 21 CFR Part 11 compliance Edited transcript below In this video interview, Vaisala Senior Regulatory Expert answers three questions from customers and industry contacts... 了解更多 博客 | Jun 18, 2020 视频问答:数据记录仪准确度和资源状况再验证 向下滚动以查看编辑的文字稿 在本视频采访中,维萨拉高级法规专家回答了来自客户和行业联系人的三个问题。如果您有后续问题,请随时在此页面上发表评论或给我们发送电子邮件。 {"preview_thumbnail":"/sites/default/files/styles/video_embed... 了解更多 博客 | May 16, 2020 Video Q&A: Switching monitoring system servers & mapping study know-how Scroll down to see the edited transcript {"preview_thumbnail":"/sites/default/files/styles/video_embed_wysiwyg_preview/public/video_thumbnails... 了解更多 博客 | Feb 26, 2020 基于风险的再验证 有关您风险分析问题的专家回答 我们的资深法规专家 Paul Daniel 很高兴通过电子邮件回答您的问题。这一周的博客出自 Paul 和一家生物制药公司的资深验证经理的电子邮件交流。 C 写到:Paul,下午好 我从事验证工作已有约 26 年... 了解更多 博客 | Nov 29, 2019 Our Most-Read Life Science Blogs of 2019 Once again we bring you a list of our most popular blogs on environmental monitoring from the last year. In case you missed them, and according... 了解更多 博客 | Nov 5, 2019 Monitoring System Integration: Q&A In our webinar "A Future-Proof Monitoring System: Ensuring Your System can Adapt to the Future of GxP" we answered several questions on how the... 了解更多 博客 | Oct 11, 2019 Dealing with Temperature Sensor Deviations We recently received a question from a reader who found an out-of-specification temperature sensor that had been monitoring a controlled... 了解更多 博客 | Aug 2, 2019 Creating SOPs for Continuous Monitoring Systems Dear Vaisala, We are hoping to save time in creating a Standard Operating Procedure for our viewLinc monitoring system. Does Vaisala offer any... 了解更多 博客 | May 13, 2019 Using Mapping Study Data to Select Monitoring Sensor Placement To be honest, I don’t recommend using the mapping data to select the location of your monitoring sensors. The entire idea is counter-intuitive... 了解更多 博客 | Apr 16, 2019 Answers from our Latest Mapping Webinar In this blog, we answer questions we received during our recent webinar “Mapping Made Easy.” If you have not seen it already, watch it now... 了解更多 博客 | Mar 9, 2019 Ready or Not, Bluetooth is coming… I’ve always loved Bluetooth for personal use. That’s not surprising because it was first designed as a tool for a PAN (Personal Area Network)... 了解更多 博客 | Jan 24, 2019 ERES Reminiscing: Thoughts on 21 CFR Part 11 Past, Present & Future I’d never heard of an Electronic Signature until 21 CFR Part 11 was first published in 1997. This iconic regulation had the uninspiring title... 了解更多 博客 | Dec 6, 2018 Temperature Mapping Worst-Case Scenarios in Refrigerators We recently received a question from a pharmaceutical customer on re-qualifying a refrigerator that had been repaired. This customer was... 了解更多 博客 | Nov 20, 2018 7 Data Integrity Hacks for GxP Compliance Last week we had a webinar on data integrity giving our Senior Regulatory Expert Paul Daniel the opportunity to answer questions on data... 了解更多 博客 | Apr 12, 2018 Q&A New VaiNet (LoRa-based) Wireless Data Loggers We had over 480 registrants for our webinar "VaiNet - a Wireless Technology that Rises Above the Crowd" Thank you to everyone who joined in, and... 了解更多 博客 | Mar 12, 2018 With Wireless Monitoring on the Rise, What Changes in Ensuring Compliance with 21 CFR Part 11? As wirelessly networked monitoring devices become more popular, many of our GxP-regulated customers ask about 21 CFR Part 11 and how it impacts... 了解更多 博客 | Feb 20, 2018 Data Base Transfers & Validation for Part 11 & Annex 11 Compliance We recently received these questions: “Are data base transfers part of software validation? If yes, how can we validate the transfer?” The... 了解更多 博客 | Feb 2, 2018 Thermal Damping of Temperature Probes: Monitoring yes, Mapping no (maybe) We receive a lot of questions on the use of thermal damping devices for temperature sensors. Mostly it depends on your application, but for... 了解更多 博客 | Jan 19, 2018 Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology... are there differences? Hello Paul... 了解更多 博客 | Jan 1, 2018 Our Most-Read Life Science Blogs in 2017 Happy New Year! Once again we bring you a list of our most popular blogs from the last year. In case you missed them, and according to our Web... 了解更多 博客 | Dec 14, 2017 Why Not Use Mean Kinetic Temperature in Cold Applications? Here’s why… Back for more on Mean Kinetic Temperature with a customer question: Hi Paul, I have reviewed Vaisala’s application note on mean kinetic... 了解更多 博客 | Nov 28, 2017 Trusting Fans for Temperature Uniformity Vs. Loading Styles & Mapping Studies We received this question from a customer performing mapping studies in fridges and cold rooms: Dear Paul, In mapping a cold chamber or room... 了解更多 博客 | Nov 2, 2017 Learn Three Keys to Data Integrity in this new Infographic 了解更多 博客 | Oct 20, 2017 What's your open door (mapping study) policy? In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door). Hi... 了解更多 博客 | Sep 29, 2017 When the mapping study says move the probe, do you need other criteria to relocate? In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are... 了解更多 博客 | Jun 29, 2017 5 Ways to Treat a Misbehaving Refrigerator Go high-end, Tune it up, Block it off, Worst-Case Scenario, Change the Set-point In this week's blog, Paul offers some advice on problem spots... 了解更多 有关 GxP 标准和法规的文章 访问我们的文章、白皮书、应用说明和电子书库...
维萨拉提供全面的参数分布试验确认解决方案,帮助您遵守 GDP (良好分销规范)法规,例如欧盟 GDP (2013/C 343/01) 和美国药典 36 版第 <1079> 以及即将出台的第 <1083 章>. 环境参数分布试验确认(在存储人用和研究药品的区域必须完成)由药品生产商、储存设施、批发分销商和 GxP 供应链中的其他利益相关者进行。查看维萨拉 IQOQ 协议样本 (PDF)。 观看系统概述视频 请参阅设备选择指南 查看库里的GxP监管条文 维萨拉环境分布试验确认包括: 分布试验套件:维萨拉数据记录仪,用于采集测量数据的 vLog 软件,以及根据联邦法规第 21 章第 11 款和附录 11 验证软件的 vLog IQ/OQ 协议。 世界级 参数分布试验服务 用于描述冷藏库、冷冻库、冷冻间、仓库、储藏区、配送中心、恒温箱或稳定室的温度和相对湿度动态。(服务范围包括欧洲、日本和中国) 可选的 自定义校准 以行业最佳准确性为目标 参数分布试验确认要求更加严格,提高了法规期望 过去几年中,良好分销规范(GDP)增加了监管重点。在很大程度上,是由加拿大卫生部门 (GUI-0069, 2011) 发起的,该机构是第一个提到温度分布试验的监管机构。全球监管机构很快就重申了这一方向,其中包括: 印度 CDSCO(中央药品标准控制组织) 中国国家药监局(中国食品与药品管理局) 欧洲 EMA(欧洲药品管理局) 这些组织先后发布了新的或更新的指导原则和文件。美国随后更新了美国药典第< 1079 >章“药品良好分销规范”。此后不久,出现了几个提供具体说明的指南。例如,国际制药工程学会的冷链管理出版物就分布试验确认传感器的放置提出了建议。美国注射剂协会的技术报告 58 讨论了如何进行与 GDP 相关的风险评估。药品检验合作计划发布了自己的 GDP 指南,紧扣欧盟的 GDP 法规。这是向全球标准化迈出的重要一步,因为 PIC/S 目前拥有 40 多个参与国。 温控供应链的行业变革迫切需要指导 同时,分销活动也在不断发展,分销链日益国际化。然而,这导致温度偏差风险增加。若得以良好执行,环境分布试验确认就是评估和消除偏差风险的理想方法。但是,良好执行分布试验确认都包括什么呢? 首先,在任何规定的药品进入冷藏区、仓库和温度控制室之前,应该始终进行分布研究。分布试验要在有代表性的条件下进行。在实践中,这意味着在冬季和夏季进行季节性分布研究。另外,分布试验要包括空载条件和装载条件。对一个区域或室进行分布试验确认后,就要根据温度波动最大的位置布置监测传感器,这些位置通常称为热点和冷点。 验证原则带来客观的确认结果 环境分布试验确认的最终目标可以总结如下: 证明温度(和湿度(需要时))的一致性。 识别不合适的存储区域。 确定有代表性的监测点 记住,参数分布研究确认不限于固定地点。对于配送链中的温度控制车辆,根据上述基本原则进行原始温度分布试验确认:装载和空载状态下具有代表性的条件下,根据研究结果,将区域排除在存储位置之外或对其进行连续监测。 有关维萨拉环境参数分布试验确认解决方案的更多信息,请参阅我们的手册,或联系您当地的服务中心。 资源 欧盟良好分销规范 GDP (2013/C 343/01) 2013 年 11 月 5 日关于人用药品良好分销规范的指导原则 美国药典 36 版 – 第 <1179> 章药品良好存储和分销规范 美国药典 36 版 – 第 <1083> 章良好分销规范(将在未来发布) 联邦法规第 21 章第 11 款电子记录/电子签名 联邦法规第 21 章第 11 款电子记录/电子签名 GUI- 0069 药品贮运中的温度控制指南,2011 年。 CDSCO 生物制品良好分销规范指导原则,2012 年。 中国国家食品药品监督管理局药品经营质量管理规范(GSP),卫生部令第 90 号,2013 年。 ISPE 良好实践指南:冷链管理,2011 年。 PDA: 技术报告 58 - 温度受控销售风险管理,2012 年。 PIC/S 良好药品分销规范指南,2014 年。 进一步阅读 法国标准 AFNOR NFx15-140 澳大利亚标准 AS2853-1986 德国标准 DIN 12880。 存储区域温度分布试验,世卫组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。 温度控制存储区域的确认,世界卫生组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。
相关产品 DL1000-1400 温度记录仪 用于受控环境温度监测与温湿度参数分布研究 维萨拉 DL1000-1400 是一款高准确度温度数据记录仪。DL1000-1400... Read more VaiNet 无线接入点 AP10 针对无线监测 VaiNet 无线连接点 AP10 是一款无线网路硬件设备,针对维萨拉的专有无线技术:VaiNet。AP10 最多可将... Read more VaiNet 无线数据记录器 RFL100 针对无线温度与湿度监测 RFL 系列数据记录器采用维萨拉的专有 VaiNet... Read more Wi-Fi 数据记录仪 HMT140 用于监控温度、相对湿度、电流、电压与门开关传感器 维萨拉 HMT140... Read more 以太网记录器接口连接的 vNet 电源 用于将 DL 系列数据记录仪连接至网络 以太网记录器接口连接的 vNet 电源是网络连接的托架,它将 DL... Read more 温湿度数据记录仪 DL2000 用于监测温度、湿度,具有可选择的模拟输入 维萨拉 DL2000... Read more 验证参数分布研究套件 对于 GxP 环境下温度和湿度的确认 ... Read more vLog VL 软件 为验证/参数分布研究 GxP 环境 该 vLog... Read more viewLinc 应用程序编程接口 将 viewLinc 与现有系统集成 维萨拉 viewLinc 监测系统测量工业和监控 GxP... Read more 采用 VaiNet 技术的无线监测系统 长距离无线通信 Read more TMP115 宽量程温度探头 适用于要求严苛的温控环境 TMP115 温度探头采用铂电阻 RTD... Read more 维萨拉数据记录仪的电缆 维萨拉电缆用于将维萨拉数据记录仪连接至标准 USB 端口和标准 RS-232 系列端口。 Read more
相关案例 博客 | Dec 17, 2020 Q&A on cybersecurity for GxP monitoring systems Welcome to another video question and answer from our webinar: "Cybersecurity in your GxP monitoring system." In this video, our Senior GxP... 了解更多 成功案例 Keeping temperature and humidity conditions under control at the Jusélius Mausoleum The mausoleum of Sigrid Jusélius is a significant cultural site in Pori, Finland. The mausoleum, built in 1901-03, is a masterpiece of the arts... 了解更多 成功案例 Easy and accurate validation system ensures competitive advantages to mapping service provider Since 1988, Performance Validation (PV) has provided validation, commissioning, and quality services to pharmaceutical, biotechnology and... 了解更多 博客 | Aug 14, 2020 Video Q&A: Guidance documents, references, and advice for warehouse mapping In this video, we answer questions we didn’t have time for during our June webinar “Continuous Mapping in Warehouses: Better Data, Better... 了解更多 博客 | Jul 14, 2020 Out-of-spec sensors, incubator hot/cold spots & 21 CFR Part 11 compliance Edited transcript below In this video interview, Vaisala Senior Regulatory Expert answers three questions from customers and industry contacts... 了解更多 博客 | Jun 18, 2020 视频问答:数据记录仪准确度和资源状况再验证 向下滚动以查看编辑的文字稿 在本视频采访中,维萨拉高级法规专家回答了来自客户和行业联系人的三个问题。如果您有后续问题,请随时在此页面上发表评论或给我们发送电子邮件。 {"preview_thumbnail":"/sites/default/files/styles/video_embed... 了解更多 博客 | May 16, 2020 Video Q&A: Switching monitoring system servers & mapping study know-how Scroll down to see the edited transcript {"preview_thumbnail":"/sites/default/files/styles/video_embed_wysiwyg_preview/public/video_thumbnails... 了解更多 博客 | Feb 26, 2020 基于风险的再验证 有关您风险分析问题的专家回答 我们的资深法规专家 Paul Daniel 很高兴通过电子邮件回答您的问题。这一周的博客出自 Paul 和一家生物制药公司的资深验证经理的电子邮件交流。 C 写到:Paul,下午好 我从事验证工作已有约 26 年... 了解更多 博客 | Nov 29, 2019 Our Most-Read Life Science Blogs of 2019 Once again we bring you a list of our most popular blogs on environmental monitoring from the last year. In case you missed them, and according... 了解更多 博客 | Nov 5, 2019 Monitoring System Integration: Q&A In our webinar "A Future-Proof Monitoring System: Ensuring Your System can Adapt to the Future of GxP" we answered several questions on how the... 了解更多 博客 | Oct 11, 2019 Dealing with Temperature Sensor Deviations We recently received a question from a reader who found an out-of-specification temperature sensor that had been monitoring a controlled... 了解更多 博客 | Aug 2, 2019 Creating SOPs for Continuous Monitoring Systems Dear Vaisala, We are hoping to save time in creating a Standard Operating Procedure for our viewLinc monitoring system. Does Vaisala offer any... 了解更多 博客 | May 13, 2019 Using Mapping Study Data to Select Monitoring Sensor Placement To be honest, I don’t recommend using the mapping data to select the location of your monitoring sensors. The entire idea is counter-intuitive... 了解更多 博客 | Apr 16, 2019 Answers from our Latest Mapping Webinar In this blog, we answer questions we received during our recent webinar “Mapping Made Easy.” If you have not seen it already, watch it now... 了解更多 博客 | Mar 9, 2019 Ready or Not, Bluetooth is coming… I’ve always loved Bluetooth for personal use. That’s not surprising because it was first designed as a tool for a PAN (Personal Area Network)... 了解更多 博客 | Jan 24, 2019 ERES Reminiscing: Thoughts on 21 CFR Part 11 Past, Present & Future I’d never heard of an Electronic Signature until 21 CFR Part 11 was first published in 1997. This iconic regulation had the uninspiring title... 了解更多 博客 | Dec 6, 2018 Temperature Mapping Worst-Case Scenarios in Refrigerators We recently received a question from a pharmaceutical customer on re-qualifying a refrigerator that had been repaired. This customer was... 了解更多 博客 | Nov 20, 2018 7 Data Integrity Hacks for GxP Compliance Last week we had a webinar on data integrity giving our Senior Regulatory Expert Paul Daniel the opportunity to answer questions on data... 了解更多 博客 | Apr 12, 2018 Q&A New VaiNet (LoRa-based) Wireless Data Loggers We had over 480 registrants for our webinar "VaiNet - a Wireless Technology that Rises Above the Crowd" Thank you to everyone who joined in, and... 了解更多 博客 | Mar 12, 2018 With Wireless Monitoring on the Rise, What Changes in Ensuring Compliance with 21 CFR Part 11? As wirelessly networked monitoring devices become more popular, many of our GxP-regulated customers ask about 21 CFR Part 11 and how it impacts... 了解更多 博客 | Feb 20, 2018 Data Base Transfers & Validation for Part 11 & Annex 11 Compliance We recently received these questions: “Are data base transfers part of software validation? If yes, how can we validate the transfer?” The... 了解更多 博客 | Feb 2, 2018 Thermal Damping of Temperature Probes: Monitoring yes, Mapping no (maybe) We receive a lot of questions on the use of thermal damping devices for temperature sensors. Mostly it depends on your application, but for... 了解更多 博客 | Jan 19, 2018 Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology... are there differences? Hello Paul... 了解更多 博客 | Jan 1, 2018 Our Most-Read Life Science Blogs in 2017 Happy New Year! Once again we bring you a list of our most popular blogs from the last year. In case you missed them, and according to our Web... 了解更多 博客 | Dec 14, 2017 Why Not Use Mean Kinetic Temperature in Cold Applications? Here’s why… Back for more on Mean Kinetic Temperature with a customer question: Hi Paul, I have reviewed Vaisala’s application note on mean kinetic... 了解更多 博客 | Nov 28, 2017 Trusting Fans for Temperature Uniformity Vs. Loading Styles & Mapping Studies We received this question from a customer performing mapping studies in fridges and cold rooms: Dear Paul, In mapping a cold chamber or room... 了解更多 博客 | Nov 2, 2017 Learn Three Keys to Data Integrity in this new Infographic 了解更多 博客 | Oct 20, 2017 What's your open door (mapping study) policy? In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door). Hi... 了解更多 博客 | Sep 29, 2017 When the mapping study says move the probe, do you need other criteria to relocate? In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are... 了解更多 博客 | Jun 29, 2017 5 Ways to Treat a Misbehaving Refrigerator Go high-end, Tune it up, Block it off, Worst-Case Scenario, Change the Set-point In this week's blog, Paul offers some advice on problem spots... 了解更多
博客 | Dec 17, 2020 Q&A on cybersecurity for GxP monitoring systems Welcome to another video question and answer from our webinar: "Cybersecurity in your GxP monitoring system." In this video, our Senior GxP... 了解更多
成功案例 Keeping temperature and humidity conditions under control at the Jusélius Mausoleum The mausoleum of Sigrid Jusélius is a significant cultural site in Pori, Finland. The mausoleum, built in 1901-03, is a masterpiece of the arts... 了解更多
成功案例 Easy and accurate validation system ensures competitive advantages to mapping service provider Since 1988, Performance Validation (PV) has provided validation, commissioning, and quality services to pharmaceutical, biotechnology and... 了解更多
博客 | Aug 14, 2020 Video Q&A: Guidance documents, references, and advice for warehouse mapping In this video, we answer questions we didn’t have time for during our June webinar “Continuous Mapping in Warehouses: Better Data, Better... 了解更多
博客 | Jul 14, 2020 Out-of-spec sensors, incubator hot/cold spots & 21 CFR Part 11 compliance Edited transcript below In this video interview, Vaisala Senior Regulatory Expert answers three questions from customers and industry contacts... 了解更多
博客 | Jun 18, 2020 视频问答:数据记录仪准确度和资源状况再验证 向下滚动以查看编辑的文字稿 在本视频采访中,维萨拉高级法规专家回答了来自客户和行业联系人的三个问题。如果您有后续问题,请随时在此页面上发表评论或给我们发送电子邮件。 {"preview_thumbnail":"/sites/default/files/styles/video_embed... 了解更多
博客 | May 16, 2020 Video Q&A: Switching monitoring system servers & mapping study know-how Scroll down to see the edited transcript {"preview_thumbnail":"/sites/default/files/styles/video_embed_wysiwyg_preview/public/video_thumbnails... 了解更多
博客 | Feb 26, 2020 基于风险的再验证 有关您风险分析问题的专家回答 我们的资深法规专家 Paul Daniel 很高兴通过电子邮件回答您的问题。这一周的博客出自 Paul 和一家生物制药公司的资深验证经理的电子邮件交流。 C 写到:Paul,下午好 我从事验证工作已有约 26 年... 了解更多
博客 | Nov 29, 2019 Our Most-Read Life Science Blogs of 2019 Once again we bring you a list of our most popular blogs on environmental monitoring from the last year. In case you missed them, and according... 了解更多
博客 | Nov 5, 2019 Monitoring System Integration: Q&A In our webinar "A Future-Proof Monitoring System: Ensuring Your System can Adapt to the Future of GxP" we answered several questions on how the... 了解更多
博客 | Oct 11, 2019 Dealing with Temperature Sensor Deviations We recently received a question from a reader who found an out-of-specification temperature sensor that had been monitoring a controlled... 了解更多
博客 | Aug 2, 2019 Creating SOPs for Continuous Monitoring Systems Dear Vaisala, We are hoping to save time in creating a Standard Operating Procedure for our viewLinc monitoring system. Does Vaisala offer any... 了解更多
博客 | May 13, 2019 Using Mapping Study Data to Select Monitoring Sensor Placement To be honest, I don’t recommend using the mapping data to select the location of your monitoring sensors. The entire idea is counter-intuitive... 了解更多
博客 | Apr 16, 2019 Answers from our Latest Mapping Webinar In this blog, we answer questions we received during our recent webinar “Mapping Made Easy.” If you have not seen it already, watch it now... 了解更多
博客 | Mar 9, 2019 Ready or Not, Bluetooth is coming… I’ve always loved Bluetooth for personal use. That’s not surprising because it was first designed as a tool for a PAN (Personal Area Network)... 了解更多
博客 | Jan 24, 2019 ERES Reminiscing: Thoughts on 21 CFR Part 11 Past, Present & Future I’d never heard of an Electronic Signature until 21 CFR Part 11 was first published in 1997. This iconic regulation had the uninspiring title... 了解更多
博客 | Dec 6, 2018 Temperature Mapping Worst-Case Scenarios in Refrigerators We recently received a question from a pharmaceutical customer on re-qualifying a refrigerator that had been repaired. This customer was... 了解更多
博客 | Nov 20, 2018 7 Data Integrity Hacks for GxP Compliance Last week we had a webinar on data integrity giving our Senior Regulatory Expert Paul Daniel the opportunity to answer questions on data... 了解更多
博客 | Apr 12, 2018 Q&A New VaiNet (LoRa-based) Wireless Data Loggers We had over 480 registrants for our webinar "VaiNet - a Wireless Technology that Rises Above the Crowd" Thank you to everyone who joined in, and... 了解更多
博客 | Mar 12, 2018 With Wireless Monitoring on the Rise, What Changes in Ensuring Compliance with 21 CFR Part 11? As wirelessly networked monitoring devices become more popular, many of our GxP-regulated customers ask about 21 CFR Part 11 and how it impacts... 了解更多
博客 | Feb 20, 2018 Data Base Transfers & Validation for Part 11 & Annex 11 Compliance We recently received these questions: “Are data base transfers part of software validation? If yes, how can we validate the transfer?” The... 了解更多
博客 | Feb 2, 2018 Thermal Damping of Temperature Probes: Monitoring yes, Mapping no (maybe) We receive a lot of questions on the use of thermal damping devices for temperature sensors. Mostly it depends on your application, but for... 了解更多
博客 | Jan 19, 2018 Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology... are there differences? Hello Paul... 了解更多
博客 | Jan 1, 2018 Our Most-Read Life Science Blogs in 2017 Happy New Year! Once again we bring you a list of our most popular blogs from the last year. In case you missed them, and according to our Web... 了解更多
博客 | Dec 14, 2017 Why Not Use Mean Kinetic Temperature in Cold Applications? Here’s why… Back for more on Mean Kinetic Temperature with a customer question: Hi Paul, I have reviewed Vaisala’s application note on mean kinetic... 了解更多
博客 | Nov 28, 2017 Trusting Fans for Temperature Uniformity Vs. Loading Styles & Mapping Studies We received this question from a customer performing mapping studies in fridges and cold rooms: Dear Paul, In mapping a cold chamber or room... 了解更多
博客 | Oct 20, 2017 What's your open door (mapping study) policy? In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door). Hi... 了解更多
博客 | Sep 29, 2017 When the mapping study says move the probe, do you need other criteria to relocate? In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are... 了解更多
博客 | Jun 29, 2017 5 Ways to Treat a Misbehaving Refrigerator Go high-end, Tune it up, Block it off, Worst-Case Scenario, Change the Set-point In this week's blog, Paul offers some advice on problem spots... 了解更多