保管倉庫の計測とモニタリング 平均動態温度を適用する方法に関する6つの基本的な提案を見る 保管倉庫および物流拠点向けのヴァイサラのソリューションが、適正流通規範（GDP）遵守エリアでの規制違反や製品損失のリスクを低減します。 システム概要ビデオを見る デバイスセレクションガイドを見る GxP規則関連の記事ライブラリを見る ヴァイサラの viewLinc継続モニタリングシステムは以下を提供します。 有線、PoE、Wi-Fi または ヴァイサラ独自の無線技術 VaiNetを用いた容易な接続による低い所有コスト Good Distribution Practiceへのコンプライアンスに関する欠損のない保護されたデータ記録 SMS、Eメール、またはローカルアラートを介した年中無休のリモート アラーム 要求に応じて自動作成されEメールで配信されるユーザー設定によるレポート 通信量の多い保管倉庫環境およびアクセスしにくい棚向けの無線センサオプション 円滑な起動のための、迅速で簡単な据付時適格性評価（IQ）/運転時適格性評価（OQ）バリデーション文書または現場設置／検証サービス スポットチェックや変換器の現場校正向けにハンディタイプの温度湿度計も提供しています。 頑丈で高精度なデータロガーにより、同じ装置で マッピング/検証研究 が可能 データロガーは非常に安定しており、検証/マッピング研究に適しています。 ヴァイサラのマッピングキットを使用すると、保管場所を認定する時間とコストを節約できます。 倉庫検証 & 検証マスタープラン 検証マスタープランは、お客様の検証作業をオーガナイズし、施設の品質目標をサポートする方法を理解することに役立ちます。マスタープランは監査員にも喜ばれます。VMPの監査準備が整っていることを確実にするため、12のチェックポイントについて 「Validation Master Plan」のブログポスト 、ならびにFDAガイダンス、ICH品質ガイドライン、EMAドラフトガイドライン、および付録15の要件のリンクをお読みください。 倉庫モニタリング & 検証の詳細 viewLincモニタリングシステム マッピングキット ネットワーク接続オプション IQOQ文書サンプル サンプルレポート 保管倉庫に対する適正保管出荷基準 薬剤、生物製剤、医療機器の保存用または保管用のエリアには、適正保管出荷基準では、製品の純度・品質・安全性に影響を及ぼす恐れがある温度や湿度などの変数を制御する環境管理システムが求められます。 続きを読む 関連製品 viewLinc モニタリング、アラーム通知、レポート作成ソフトウェア 温度、湿度そしてその他のパラメータの継続監視システム（CMS） viewLinc Enterprise Server... Read more viewLinc モニタリングシステム Read more HMT330シリーズ 湿度温度変換器 厳しい環境での温湿度計測用 ... Read more HMT360シリーズ 本質安全防爆構造 湿度温度変換器 危険区域での湿度計測用 ヴァイサラ HUMICAP® HMT360シリーズ 本質安全防爆構造... Read more DMT340シリーズ 露点変換器 低露点計測用 DMT340シリーズ... Read more HMD60シリーズ 湿度温度変換器 要求の厳しい一般空調（HVAC）用途向けの校正証明書付き変換器、精度：±1.5%RH ヴァイサラ HUMICAP® HMD60シリーズ... Read more HMDW110シリーズ 湿度温度変換器 一般空調設備（HVAC）における高精度計測向け、精度±2%RHの変換器（校正証明書付き） ヴァイサラ... Read more HMDW80シリーズ 湿度温度変換器 標準的な一般空調設備（HVAC）用途向け、精度±3%RHの低メンテナンス変換器 ... Read more HMT120/130 湿度温度変換器 クリーンルームや軽工業用途向け、プローブ交換が可能な精度±1.5%RHの変換器 ヴァイサラ HUMICAP® HMT120/HMT130... Read more DL1000/1400 温度データロガー 厳しい環境下における温度モニタリング&マッピング向け ヴァイサラ... Read more DL1016/1416 温度データロガー 広範囲計測の温度モニタリング向け ヴァイサラの多用途温度データロガーは、超低温フリーザ... Read more DL2000 温湿度データロガー 温湿度モニタリング用（オプションでアナログ入力付き） ヴァイサラ DL2000... Read more HMT140 Wi-Fi データロガー 温度、相対湿度、電流、電圧のモニタリング用やドア接触センサに接続可能 ヴァイサラ HMT140... Read more vNet PoEデータロガーインターフェース DLシリーズデータロガーのネットワーク接続用 ヴァイサラ vNet PoE（Power over... Read more バリデーション/マッピングキット 適正規範 GxP 適用環境での温度と湿度の確認用 ... Read more vLog SP 温度&湿度のトレンディングおよび分析用 ヴァイサラ vLog SPは強力で使いやすいソフトウェアで、ヴァイサラ... Read more vLog VL ソフトウェア 適正規範 （GxP) 適用環境の検証/マッピング用 vLog... Read more viewLinc アプリケーションプログラミングインターフェース viewLinc と既存のシステムを統合するには ヴァイサラ viewLinc... Read more ヴァイサラ OPC UA サーバー データ収集とシステム制御向け Read more 環境モニタリングシステム（CMS）サービス CMSのサポート、トレーニング、サービス 当社ではヴァイサラ... Read more PTB330TS 気圧標準器 バッテリー電源でポータブル、データ機能付 PTB330TS 気圧標準器は、PTB330... Read more ヴァイサラ データロガー用ケーブル ... Read more 関連事例 Blog | 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... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む Blog | 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.... 続きを読む Blog | 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.... 続きを読む Blog | 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).... 続きを読む プレスリリース | Feb 27, 2019 Vaisala’s Wireless viewLinc Monitoring System Received Quality Innovation Award Vaisala Press Release February 27, 2019 Vaisala’s Wireless viewLinc... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む プレスリリース | Dec 4, 2018 Vaisala viewLinc Monitoring System Awarded by Laatukeskus Excellence Finland Vaisala Press Release December 4, 2018 Vaisala's viewLinc Monitoring System... 続きを読む Blog | 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... 続きを読む Blog | Sep 14, 2018 Mean Kinetic Humidity? Answers & Advice from our MKT Webinar These are a selection of questions that were answered in our recent webinar on Mean Kinetic Temperature . These questions are a sample, to hear... 続きを読む Blog | May 14, 2018 Notes from the Field: Installing a New Wireless Temperature & Humidity Monitoring System We recently made several software enhancements to our viewLinc 5.0 Enterprise Server software for continuous monitoring of controlled... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む プレスリリース | Feb 21, 2018 ヴァイサラ、交換可能な4種類の湿度温度プローブと温度プローブの販売を開始 ヴァイサラ株式会社は、厳しい要件が求められる産業用途向けに設計された交換が可能なインテリジェントプローブ5種類の販売を開始いたします。 続きを読む Success Story Keeping Pathogens at Bay Global mobility for people means mobility for pathogens, too. Vaisala provides a solution to ensuring vaporized hydrogen peroxide concentration... 続きを読む Blog | 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... 続きを読む Blog | Nov 2, 2017 Learn Three Keys to Data Integrity in this new Infographic 続きを読む Blog | Jul 14, 2017 Is the term Controlled Room Temperature Falling out of Fashion in Regulated Industry? Specificity Seems to be all the Rage this Season Hi Paul, I came across an article about, "stability data vs USP 36" on your website. I am... 続きを読む Success Story Vaisala Honorary In-kind Donator for New Children’s Hospital Vaisala will be contributing humidity, temperature, and carbon dioxide measurement instruments to the new children’s hospital to be constructed... 続きを読む Blog | May 2, 2017 Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides... 続きを読む Blog | Apr 10, 2017 Part 11 for Process Equipment, Audit Trail Reviewing, Requirements for Bulk Chemicals, And Cal Certs Without Pass/Fail This week we have five move post-webinar questions from the Data Integrity webinar. The questions are: Do we need to comply with Part 11 for a... 続きを読む Blog | Mar 28, 2017 Q&A from our Data Integrity Webinar (Plus - another Webinar!) This week we are sharing some of the post-webinar questions sent to us after our Data Integrity webinar. If you missed it, watch the recorded... 続きを読む Blog | Feb 25, 2017 Common questions on MKT answered: Trending, Interpreting Reports, & Default Activation Energy In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. Dear Paul, I have a couple... 続きを読む Blog | Feb 15, 2017 Three Questions you need to Answer for Monitoring Controlled-Temperature Chambers In PharmTech's recent publication Vol 9, Issue 12 Manufacturing Sector Editor Jennifer Markarian interviewed Vaisala Regulatory Expert Paul... 続きを読む Blog | Dec 17, 2016 Can you use Mean Kinetic Temperature to Account for Spikes in Accelerated Aging Chambers? In this week's blog, Paul Daniel has a little back and forth on a question he received from a webinar attendee on using mean kinetic temperature... 続きを読む Blog | Dec 6, 2016 Sensor Breakdown for Chambers Vs Room Monitoring: What Sensors are best for Your Application? Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much... 続きを読む Blog | Jun 15, 2016 Streamlining stability testing... Sample intervals 10 seconds Vs 10 minutes In this week's blog, Piritta Maunu answers a question she received after her recent webinar: Stability Studies & Monitoring . But first...... 続きを読む GxP基準規則の条項 記事、ホワイトペーパー、アプリケーションノート、Eブックなどを収めた当社の所蔵庫をご覧ください。
保管倉庫および物流拠点向けのヴァイサラのソリューションが、適正流通規範（GDP）遵守エリアでの規制違反や製品損失のリスクを低減します。 システム概要ビデオを見る デバイスセレクションガイドを見る GxP規則関連の記事ライブラリを見る ヴァイサラの viewLinc継続モニタリングシステムは以下を提供します。 有線、PoE、Wi-Fi または ヴァイサラ独自の無線技術 VaiNetを用いた容易な接続による低い所有コスト Good Distribution Practiceへのコンプライアンスに関する欠損のない保護されたデータ記録 SMS、Eメール、またはローカルアラートを介した年中無休のリモート アラーム 要求に応じて自動作成されEメールで配信されるユーザー設定によるレポート 通信量の多い保管倉庫環境およびアクセスしにくい棚向けの無線センサオプション 円滑な起動のための、迅速で簡単な据付時適格性評価（IQ）/運転時適格性評価（OQ）バリデーション文書または現場設置／検証サービス スポットチェックや変換器の現場校正向けにハンディタイプの温度湿度計も提供しています。 頑丈で高精度なデータロガーにより、同じ装置で マッピング/検証研究 が可能 データロガーは非常に安定しており、検証/マッピング研究に適しています。 ヴァイサラのマッピングキットを使用すると、保管場所を認定する時間とコストを節約できます。 倉庫検証 & 検証マスタープラン 検証マスタープランは、お客様の検証作業をオーガナイズし、施設の品質目標をサポートする方法を理解することに役立ちます。マスタープランは監査員にも喜ばれます。VMPの監査準備が整っていることを確実にするため、12のチェックポイントについて 「Validation Master Plan」のブログポスト 、ならびにFDAガイダンス、ICH品質ガイドライン、EMAドラフトガイドライン、および付録15の要件のリンクをお読みください。 倉庫モニタリング & 検証の詳細 viewLincモニタリングシステム マッピングキット ネットワーク接続オプション IQOQ文書サンプル サンプルレポート
保管倉庫に対する適正保管出荷基準 薬剤、生物製剤、医療機器の保存用または保管用のエリアには、適正保管出荷基準では、製品の純度・品質・安全性に影響を及ぼす恐れがある温度や湿度などの変数を制御する環境管理システムが求められます。 続きを読む
関連製品 viewLinc モニタリング、アラーム通知、レポート作成ソフトウェア 温度、湿度そしてその他のパラメータの継続監視システム（CMS） viewLinc Enterprise Server... Read more viewLinc モニタリングシステム Read more HMT330シリーズ 湿度温度変換器 厳しい環境での温湿度計測用 ... Read more HMT360シリーズ 本質安全防爆構造 湿度温度変換器 危険区域での湿度計測用 ヴァイサラ HUMICAP® HMT360シリーズ 本質安全防爆構造... Read more DMT340シリーズ 露点変換器 低露点計測用 DMT340シリーズ... Read more HMD60シリーズ 湿度温度変換器 要求の厳しい一般空調（HVAC）用途向けの校正証明書付き変換器、精度：±1.5%RH ヴァイサラ HUMICAP® HMD60シリーズ... Read more HMDW110シリーズ 湿度温度変換器 一般空調設備（HVAC）における高精度計測向け、精度±2%RHの変換器（校正証明書付き） ヴァイサラ... Read more HMDW80シリーズ 湿度温度変換器 標準的な一般空調設備（HVAC）用途向け、精度±3%RHの低メンテナンス変換器 ... Read more HMT120/130 湿度温度変換器 クリーンルームや軽工業用途向け、プローブ交換が可能な精度±1.5%RHの変換器 ヴァイサラ HUMICAP® HMT120/HMT130... Read more DL1000/1400 温度データロガー 厳しい環境下における温度モニタリング&マッピング向け ヴァイサラ... Read more DL1016/1416 温度データロガー 広範囲計測の温度モニタリング向け ヴァイサラの多用途温度データロガーは、超低温フリーザ... Read more DL2000 温湿度データロガー 温湿度モニタリング用（オプションでアナログ入力付き） ヴァイサラ DL2000... Read more HMT140 Wi-Fi データロガー 温度、相対湿度、電流、電圧のモニタリング用やドア接触センサに接続可能 ヴァイサラ HMT140... Read more vNet PoEデータロガーインターフェース DLシリーズデータロガーのネットワーク接続用 ヴァイサラ vNet PoE（Power over... Read more バリデーション/マッピングキット 適正規範 GxP 適用環境での温度と湿度の確認用 ... Read more vLog SP 温度&湿度のトレンディングおよび分析用 ヴァイサラ vLog SPは強力で使いやすいソフトウェアで、ヴァイサラ... Read more vLog VL ソフトウェア 適正規範 （GxP) 適用環境の検証/マッピング用 vLog... Read more viewLinc アプリケーションプログラミングインターフェース viewLinc と既存のシステムを統合するには ヴァイサラ viewLinc... Read more ヴァイサラ OPC UA サーバー データ収集とシステム制御向け Read more 環境モニタリングシステム（CMS）サービス CMSのサポート、トレーニング、サービス 当社ではヴァイサラ... Read more PTB330TS 気圧標準器 バッテリー電源でポータブル、データ機能付 PTB330TS 気圧標準器は、PTB330... Read more ヴァイサラ データロガー用ケーブル ... Read more
viewLinc モニタリング、アラーム通知、レポート作成ソフトウェア 温度、湿度そしてその他のパラメータの継続監視システム（CMS） viewLinc Enterprise Server... Read more
関連事例 Blog | 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... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む Blog | 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.... 続きを読む Blog | 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.... 続きを読む Blog | 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).... 続きを読む プレスリリース | Feb 27, 2019 Vaisala’s Wireless viewLinc Monitoring System Received Quality Innovation Award Vaisala Press Release February 27, 2019 Vaisala’s Wireless viewLinc... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む プレスリリース | Dec 4, 2018 Vaisala viewLinc Monitoring System Awarded by Laatukeskus Excellence Finland Vaisala Press Release December 4, 2018 Vaisala's viewLinc Monitoring System... 続きを読む Blog | 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... 続きを読む Blog | Sep 14, 2018 Mean Kinetic Humidity? Answers & Advice from our MKT Webinar These are a selection of questions that were answered in our recent webinar on Mean Kinetic Temperature . These questions are a sample, to hear... 続きを読む Blog | May 14, 2018 Notes from the Field: Installing a New Wireless Temperature & Humidity Monitoring System We recently made several software enhancements to our viewLinc 5.0 Enterprise Server software for continuous monitoring of controlled... 続きを読む Blog | 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... 続きを読む Blog | 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... 続きを読む プレスリリース | Feb 21, 2018 ヴァイサラ、交換可能な4種類の湿度温度プローブと温度プローブの販売を開始 ヴァイサラ株式会社は、厳しい要件が求められる産業用途向けに設計された交換が可能なインテリジェントプローブ5種類の販売を開始いたします。 続きを読む Success Story Keeping Pathogens at Bay Global mobility for people means mobility for pathogens, too. Vaisala provides a solution to ensuring vaporized hydrogen peroxide concentration... 続きを読む Blog | 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... 続きを読む Blog | Nov 2, 2017 Learn Three Keys to Data Integrity in this new Infographic 続きを読む Blog | Jul 14, 2017 Is the term Controlled Room Temperature Falling out of Fashion in Regulated Industry? Specificity Seems to be all the Rage this Season Hi Paul, I came across an article about, "stability data vs USP 36" on your website. I am... 続きを読む Success Story Vaisala Honorary In-kind Donator for New Children’s Hospital Vaisala will be contributing humidity, temperature, and carbon dioxide measurement instruments to the new children’s hospital to be constructed... 続きを読む Blog | May 2, 2017 Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides... 続きを読む Blog | Apr 10, 2017 Part 11 for Process Equipment, Audit Trail Reviewing, Requirements for Bulk Chemicals, And Cal Certs Without Pass/Fail This week we have five move post-webinar questions from the Data Integrity webinar. The questions are: Do we need to comply with Part 11 for a... 続きを読む Blog | Mar 28, 2017 Q&A from our Data Integrity Webinar (Plus - another Webinar!) This week we are sharing some of the post-webinar questions sent to us after our Data Integrity webinar. If you missed it, watch the recorded... 続きを読む Blog | Feb 25, 2017 Common questions on MKT answered: Trending, Interpreting Reports, & Default Activation Energy In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. Dear Paul, I have a couple... 続きを読む Blog | Feb 15, 2017 Three Questions you need to Answer for Monitoring Controlled-Temperature Chambers In PharmTech's recent publication Vol 9, Issue 12 Manufacturing Sector Editor Jennifer Markarian interviewed Vaisala Regulatory Expert Paul... 続きを読む Blog | Dec 17, 2016 Can you use Mean Kinetic Temperature to Account for Spikes in Accelerated Aging Chambers? In this week's blog, Paul Daniel has a little back and forth on a question he received from a webinar attendee on using mean kinetic temperature... 続きを読む Blog | Dec 6, 2016 Sensor Breakdown for Chambers Vs Room Monitoring: What Sensors are best for Your Application? Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much... 続きを読む Blog | Jun 15, 2016 Streamlining stability testing... Sample intervals 10 seconds Vs 10 minutes In this week's blog, Piritta Maunu answers a question she received after her recent webinar: Stability Studies & Monitoring . But first...... 続きを読む
Blog | 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... 続きを読む
Blog | 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... 続きを読む
Blog | 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... 続きを読む
Blog | 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... 続きを読む
Blog | 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.... 続きを読む
Blog | 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.... 続きを読む
Blog | 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).... 続きを読む
プレスリリース | Feb 27, 2019 Vaisala’s Wireless viewLinc Monitoring System Received Quality Innovation Award Vaisala Press Release February 27, 2019 Vaisala’s Wireless viewLinc... 続きを読む
Blog | 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... 続きを読む
Blog | 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... 続きを読む
プレスリリース | Dec 4, 2018 Vaisala viewLinc Monitoring System Awarded by Laatukeskus Excellence Finland Vaisala Press Release December 4, 2018 Vaisala's viewLinc Monitoring System... 続きを読む
Blog | 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... 続きを読む
Blog | Sep 14, 2018 Mean Kinetic Humidity? Answers & Advice from our MKT Webinar These are a selection of questions that were answered in our recent webinar on Mean Kinetic Temperature . These questions are a sample, to hear... 続きを読む
Blog | May 14, 2018 Notes from the Field: Installing a New Wireless Temperature & Humidity Monitoring System We recently made several software enhancements to our viewLinc 5.0 Enterprise Server software for continuous monitoring of controlled... 続きを読む
Blog | 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... 続きを読む
Blog | 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... 続きを読む
プレスリリース | Feb 21, 2018 ヴァイサラ、交換可能な4種類の湿度温度プローブと温度プローブの販売を開始 ヴァイサラ株式会社は、厳しい要件が求められる産業用途向けに設計された交換が可能なインテリジェントプローブ5種類の販売を開始いたします。 続きを読む
Success Story Keeping Pathogens at Bay Global mobility for people means mobility for pathogens, too. Vaisala provides a solution to ensuring vaporized hydrogen peroxide concentration... 続きを読む
Blog | 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... 続きを読む
Blog | Jul 14, 2017 Is the term Controlled Room Temperature Falling out of Fashion in Regulated Industry? Specificity Seems to be all the Rage this Season Hi Paul, I came across an article about, "stability data vs USP 36" on your website. I am... 続きを読む
Success Story Vaisala Honorary In-kind Donator for New Children’s Hospital Vaisala will be contributing humidity, temperature, and carbon dioxide measurement instruments to the new children’s hospital to be constructed... 続きを読む
Blog | May 2, 2017 Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides... 続きを読む
Blog | Apr 10, 2017 Part 11 for Process Equipment, Audit Trail Reviewing, Requirements for Bulk Chemicals, And Cal Certs Without Pass/Fail This week we have five move post-webinar questions from the Data Integrity webinar. The questions are: Do we need to comply with Part 11 for a... 続きを読む
Blog | Mar 28, 2017 Q&A from our Data Integrity Webinar (Plus - another Webinar!) This week we are sharing some of the post-webinar questions sent to us after our Data Integrity webinar. If you missed it, watch the recorded... 続きを読む
Blog | Feb 25, 2017 Common questions on MKT answered: Trending, Interpreting Reports, & Default Activation Energy In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. Dear Paul, I have a couple... 続きを読む
Blog | Feb 15, 2017 Three Questions you need to Answer for Monitoring Controlled-Temperature Chambers In PharmTech's recent publication Vol 9, Issue 12 Manufacturing Sector Editor Jennifer Markarian interviewed Vaisala Regulatory Expert Paul... 続きを読む
Blog | Dec 17, 2016 Can you use Mean Kinetic Temperature to Account for Spikes in Accelerated Aging Chambers? In this week's blog, Paul Daniel has a little back and forth on a question he received from a webinar attendee on using mean kinetic temperature... 続きを読む
Blog | Dec 6, 2016 Sensor Breakdown for Chambers Vs Room Monitoring: What Sensors are best for Your Application? Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much... 続きを読む
Blog | Jun 15, 2016 Streamlining stability testing... Sample intervals 10 seconds Vs 10 minutes In this week's blog, Piritta Maunu answers a question she received after her recent webinar: Stability Studies & Monitoring . But first...... 続きを読む
