冷蔵庫/フリーザーの温度モニタリング Vaisala fridge and freezer monitoring, alarming, and reporting solutions reduce the risk of lost product and regulatory non-compliance in life science cold storage applications. 有線・無線を含む複数の接続オプションにより、フリーザーの温度モニタリングに最適な、設定が簡単で使いやすいシステムです。 システム概要ビデオを見る データロガー選択ガイドを参照 規制記事のライブラリを見る 冷蔵庫・フリーザーの温度のモニタリングのメリット 既存のネットワークへの簡単な接続、モニタリングされた冷蔵庫・フリーザーへのリモートアクセス、最大数千までのモニタリング場所の拡張性によって、所有コストを低減 USP797、21 CFR Part 11(連邦規則第21条第11章)をはじめとする主要な規制基準を遵守した欠損のない保護されたデータ記録 SMS、Eメール、現地の警告などによる、フリーザー温度やドアの24時間365日のリモートアラーム... 時間設定または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 円滑な稼働および高い生産性のための、迅速で簡単な据付時適格性評価(IQ)/運転時適格性評価(OQ)バリデーションおよび現場設置サービス 特長 完全なオーディットトレイルによる欠損のないデータ記録。電池駆動のロガーはネットワークの故障や停電の影響を受けません。電池の寿命は10年です。 冷蔵庫・フリーザーの24時間のアラーム機能は、テキストメッセージ、Eメール、現地の警報、ダイヤルアウトなどを通して、簡単に設定できます。 冷蔵庫・フリーザーに有線・無線どちらでも接続できるので、迅速で簡単に設置できます。 スケーラブルなリモートモニタリング – 一台の冷蔵庫やフリーザー、低温室から複数の施設にいたるまで、世界中のどこでも設置できます。 既存のネットワークに簡単に接続できるので、ITおよび設置コストを軽減します。 -90°C(-130°F)までのフリーザー用の温度データロガーを含む、超低温用オプションが選択できます。 GxPに準拠するための冷蔵庫フリーザー温度モニタリング、アラームレポート作成 関連製品 See a wide selection of monitoring devices 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 viewLinc Enterprise Server ソフトウェアは、温度、相対湿度、CO2、差圧、高低差、ドア接点など、多数のパラメータのモニタリングが可能で、既存ネットワークへの接続の容易性、リモートアクセス性、モニタリングポイントを数千まで追加できる拡張性によって、機器の所有コストを低減させています。 続きを読む RFL100 VaiNet ワイヤレス温度湿度データロガー RFL100 データロガーでは、ヴァイサラ独自の VaiNet ワイヤレステクノロジーが使用されており、倉庫から、製造現場、クリーンルーム、そして研究所に至るまでさまざまな環境をモニタリングできます。 続きを読む DL1016/1416 温度データロガー ヴァイサラの多用途温度データロガーは、超低温フリーザー、冷凍・冷蔵庫、インキュベータの 4 用途の温度を 1 台でモニタリングします。 続きを読む DL1000/1400 温度データロガー ヴァイサラ DL1000/1400は高精度の温度データロガーです。DL1000/1400 温度データロガーは、超低温冷凍庫、冷蔵庫、コールドルームなどの規制対象となる環境下に理想的で、安定し、信頼のできる計測値を提供します。 続きを読む Contact us 関連事例 事例 GMP monitoring system brings peace of mind to drug manufacturer The quality of manufactured or processed products at cleanroom facilities are protected by applicable good manufacturing practices (GMP) that... 続きを読む ブログ | Sep 5, 2023 GxP Temperature Mapping: Acceptance Criteria & Reporting In this blog, Vaisala Senior GxP Regulatory Expert Paul Daniel and validation/commissioning expert Nathan Roman answer questions on validation... 続きを読む ブログ | Aug 15, 2023 Managing GxP Monitoring System Alarms In this video blog, two validation experts answer questions on best practices for managing alarm functions for monitoring systems in GxP... 続きを読む 事例 Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health In April 2023, Cyto-Facto Inc. (CF), a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing... 続きを読む ブログ | Jul 19, 2023 Temperature Mapping Study Design, Duration & Intervals In this video blog, two validation experts answer questions on best practices for mapping study design, including sensor placement, study... 続きを読む ブログ | Jun 23, 2023 Can you safely copy GxP data? After watching our webinar "GxP data integrity: What you don't know may make you non-compliant", we received an interesting question about... 続きを読む 事例 Accurate environmental measurements in microbiology: Neutral Bioassay Co., Ltd. virus clearance process validation In recent years, a wide range of biological products have been used to create new drugs and therapies. However, the production processes for... 続きを読む ブログ | May 24, 2023 Intrinsically safe measurements in pharmaceutical hazardous environments Ono Pharmaceutical Co., Ltd. is one of Japan’s largest pharmaceutical companies. Their history goes back to 1717 Osaka and has been known as Ono... 続きを読む ブログ | May 15, 2023 World Metrology Day 2023: An interview with Heather Wade In this blog, Vaisala Boston Service Center Manager Alberto Benitez interviews Heather Wade, of Heather Wade Group LLC about her recent work as... 続きを読む ブログ | Mar 18, 2023 Are PDFs secure enough for GxP? This is a question that came up during our webinar on Data Integrity. In this blog, we answer at length. This is a common concern because, with... 続きを読む ブログ | Mar 8, 2023 Spot-checking measurements of environmental conditions Field spot-checking is a common way to determine the measurement accuracy of a fixed measurement instrument between calibration intervals... 続きを読む ブログ | Feb 4, 2023 Data Integrity & ALCOA++ principles in GxP continuous monitoring In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we received many questions. Vaisala Senior GxP... 続きを読む ブログ | Dec 2, 2022 How to time periodic audit trail reviews In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we had over 480 registrants. With so much interest in... 続きを読む 事例 Science-based skincare benefits from continuous monitoring & efficient validation PDF Established in 2000, Crown Laboratories is a global company that researches, develops, and manufactures skincare products ranging from over... 続きを読む ブログ | Aug 17, 2022 Part 3 – Final Q&A on controlled temperature chamber validation In this third and final video blog, Paul Daniel and Nathan Roman answer more questions, this time focusing on loaded chamber mapping with empty... 続きを読む ブログ | Jul 20, 2022 Part 2 - Q&A from our controlled temperature chamber validation webinar In this video blog, Vaisala's Paul Daniel and Nathan Roman of Genesis AEC continue to answer questions on how to validate temperature-controlled... 続きを読む ブログ | Jul 13, 2022 You asked, we answered - Another validation webinar Q&A In this blog, we present questions we didn't have time to answer during our "Ask Me Anything on Validation" webinar. If you haven't yet watched... 続きを読む 事例 Vaisala supports the Sorbonne in environmental research on pesticides Since 2016, the Institute of Ecology and Environmental Sciences (IEES) at the Sorbonne University in Paris has been using the Vaisala Continuous... 続きを読む ブログ | Jun 21, 2022 Controlled Temperature Chamber Validation Webinar Q&A Part 1 In this first of a 3-part series of video blogs, our presenters will answer the questions on validating temperature-controlled chambers. For... 続きを読む ブログ | Apr 29, 2022 Temperature-controlled storage: Can you switch temperature set points seasonally? Vaisala Senior GxP Regulatory Expert Paul Daniel often receives questions about validation. Most questions are common to others in GxP-regulated... 続きを読む ブログ | Apr 25, 2022 GxPモニタリングシステムの優れた導入と長寿命を実現するための3つのポイント このブログでは、ヴァイサラがどのようにviewLincシステムの製品寿命を維持しているのかをご説明します。 続きを読む ブログ | Mar 23, 2022 Guest blog: Temperature mapping studies - Simplifying with validation services What is the current state of how GxP industry performs temperature mapping? Current Good Manufacturing Practice (CGMP), according to the FDA's... 続きを読む 事例 Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies View PDF Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are... 続きを読む ブログ | Mar 5, 2022 Top US hospital ensures regulatory compliance for blood, drugs, vaccines, & nutrition In a US-based hospital recognized as one of the top 10 most innovative healthcare systems for its clinical care and groundbreaking use of... 続きを読む ブログ | Feb 23, 2022 The complex world of compounding labs The American Pharmacist’s Association (APhA) defines compounding as “the creation of a pharmaceutical preparation—a drug—by a licensed... 続きを読む 事例 LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity Photo Source: Lyophilization Services of New England, Inc PDF Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma... 続きを読む ブログ | Jan 20, 2022 マッピング試験の組み合わせ:真空オーブン、倉庫、LN2タンク、CO2 このブログは「継続的なマッピング」のウェブセミナー開催後、いただいたいくつかの質問にお答えします。 続きを読む ブログ | Dec 3, 2021 2021 Best blogs on monitoring & mapping GMP applications The results are in, based on unique web page views, the blogs below were our most popular in 2021. We've also added a few from 2020 that... 続きを読む ブログ | Dec 1, 2021 An introduction to Vaisala viewLinc In the third and final blog post in this series on Modbus we take a look at Vaisala viewLinc, a digital monitoring system that’s especially... 続きを読む ブログ | Nov 19, 2021 FAQ on continuous monitoring systems, building management systems, OPC UA & API In our webinar “Continuous Monitoring Systems & Building Management Systems” we outlined several differences between building management and... 続きを読む GxP 基準および規則の条項 記事、ホワイトペーパー、アプリケーションノート、eBook などはこちらをご覧ください。
Vaisala fridge and freezer monitoring, alarming, and reporting solutions reduce the risk of lost product and regulatory non-compliance in life science cold storage applications. 有線・無線を含む複数の接続オプションにより、フリーザーの温度モニタリングに最適な、設定が簡単で使いやすいシステムです。 システム概要ビデオを見る データロガー選択ガイドを参照 規制記事のライブラリを見る
冷蔵庫・フリーザーの温度のモニタリングのメリット 既存のネットワークへの簡単な接続、モニタリングされた冷蔵庫・フリーザーへのリモートアクセス、最大数千までのモニタリング場所の拡張性によって、所有コストを低減 USP797、21 CFR Part 11(連邦規則第21条第11章)をはじめとする主要な規制基準を遵守した欠損のない保護されたデータ記録 SMS、Eメール、現地の警告などによる、フリーザー温度やドアの24時間365日のリモートアラーム... 時間設定または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 円滑な稼働および高い生産性のための、迅速で簡単な据付時適格性評価(IQ)/運転時適格性評価(OQ)バリデーションおよび現場設置サービス 特長 完全なオーディットトレイルによる欠損のないデータ記録。電池駆動のロガーはネットワークの故障や停電の影響を受けません。電池の寿命は10年です。 冷蔵庫・フリーザーの24時間のアラーム機能は、テキストメッセージ、Eメール、現地の警報、ダイヤルアウトなどを通して、簡単に設定できます。 冷蔵庫・フリーザーに有線・無線どちらでも接続できるので、迅速で簡単に設置できます。 スケーラブルなリモートモニタリング – 一台の冷蔵庫やフリーザー、低温室から複数の施設にいたるまで、世界中のどこでも設置できます。 既存のネットワークに簡単に接続できるので、ITおよび設置コストを軽減します。 -90°C(-130°F)までのフリーザー用の温度データロガーを含む、超低温用オプションが選択できます。 GxPに準拠するための冷蔵庫フリーザー温度モニタリング、アラームレポート作成
関連製品 See a wide selection of monitoring devices 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 viewLinc Enterprise Server ソフトウェアは、温度、相対湿度、CO2、差圧、高低差、ドア接点など、多数のパラメータのモニタリングが可能で、既存ネットワークへの接続の容易性、リモートアクセス性、モニタリングポイントを数千まで追加できる拡張性によって、機器の所有コストを低減させています。 続きを読む RFL100 VaiNet ワイヤレス温度湿度データロガー RFL100 データロガーでは、ヴァイサラ独自の VaiNet ワイヤレステクノロジーが使用されており、倉庫から、製造現場、クリーンルーム、そして研究所に至るまでさまざまな環境をモニタリングできます。 続きを読む DL1016/1416 温度データロガー ヴァイサラの多用途温度データロガーは、超低温フリーザー、冷凍・冷蔵庫、インキュベータの 4 用途の温度を 1 台でモニタリングします。 続きを読む DL1000/1400 温度データロガー ヴァイサラ DL1000/1400は高精度の温度データロガーです。DL1000/1400 温度データロガーは、超低温冷凍庫、冷蔵庫、コールドルームなどの規制対象となる環境下に理想的で、安定し、信頼のできる計測値を提供します。 続きを読む Contact us
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 viewLinc Enterprise Server ソフトウェアは、温度、相対湿度、CO2、差圧、高低差、ドア接点など、多数のパラメータのモニタリングが可能で、既存ネットワークへの接続の容易性、リモートアクセス性、モニタリングポイントを数千まで追加できる拡張性によって、機器の所有コストを低減させています。 続きを読む
RFL100 VaiNet ワイヤレス温度湿度データロガー RFL100 データロガーでは、ヴァイサラ独自の VaiNet ワイヤレステクノロジーが使用されており、倉庫から、製造現場、クリーンルーム、そして研究所に至るまでさまざまな環境をモニタリングできます。 続きを読む
DL1000/1400 温度データロガー ヴァイサラ DL1000/1400は高精度の温度データロガーです。DL1000/1400 温度データロガーは、超低温冷凍庫、冷蔵庫、コールドルームなどの規制対象となる環境下に理想的で、安定し、信頼のできる計測値を提供します。 続きを読む
関連事例 事例 GMP monitoring system brings peace of mind to drug manufacturer The quality of manufactured or processed products at cleanroom facilities are protected by applicable good manufacturing practices (GMP) that... 続きを読む ブログ | Sep 5, 2023 GxP Temperature Mapping: Acceptance Criteria & Reporting In this blog, Vaisala Senior GxP Regulatory Expert Paul Daniel and validation/commissioning expert Nathan Roman answer questions on validation... 続きを読む ブログ | Aug 15, 2023 Managing GxP Monitoring System Alarms In this video blog, two validation experts answer questions on best practices for managing alarm functions for monitoring systems in GxP... 続きを読む 事例 Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health In April 2023, Cyto-Facto Inc. (CF), a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing... 続きを読む ブログ | Jul 19, 2023 Temperature Mapping Study Design, Duration & Intervals In this video blog, two validation experts answer questions on best practices for mapping study design, including sensor placement, study... 続きを読む ブログ | Jun 23, 2023 Can you safely copy GxP data? After watching our webinar "GxP data integrity: What you don't know may make you non-compliant", we received an interesting question about... 続きを読む 事例 Accurate environmental measurements in microbiology: Neutral Bioassay Co., Ltd. virus clearance process validation In recent years, a wide range of biological products have been used to create new drugs and therapies. However, the production processes for... 続きを読む ブログ | May 24, 2023 Intrinsically safe measurements in pharmaceutical hazardous environments Ono Pharmaceutical Co., Ltd. is one of Japan’s largest pharmaceutical companies. Their history goes back to 1717 Osaka and has been known as Ono... 続きを読む ブログ | May 15, 2023 World Metrology Day 2023: An interview with Heather Wade In this blog, Vaisala Boston Service Center Manager Alberto Benitez interviews Heather Wade, of Heather Wade Group LLC about her recent work as... 続きを読む ブログ | Mar 18, 2023 Are PDFs secure enough for GxP? This is a question that came up during our webinar on Data Integrity. In this blog, we answer at length. This is a common concern because, with... 続きを読む ブログ | Mar 8, 2023 Spot-checking measurements of environmental conditions Field spot-checking is a common way to determine the measurement accuracy of a fixed measurement instrument between calibration intervals... 続きを読む ブログ | Feb 4, 2023 Data Integrity & ALCOA++ principles in GxP continuous monitoring In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we received many questions. Vaisala Senior GxP... 続きを読む ブログ | Dec 2, 2022 How to time periodic audit trail reviews In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we had over 480 registrants. With so much interest in... 続きを読む 事例 Science-based skincare benefits from continuous monitoring & efficient validation PDF Established in 2000, Crown Laboratories is a global company that researches, develops, and manufactures skincare products ranging from over... 続きを読む ブログ | Aug 17, 2022 Part 3 – Final Q&A on controlled temperature chamber validation In this third and final video blog, Paul Daniel and Nathan Roman answer more questions, this time focusing on loaded chamber mapping with empty... 続きを読む ブログ | Jul 20, 2022 Part 2 - Q&A from our controlled temperature chamber validation webinar In this video blog, Vaisala's Paul Daniel and Nathan Roman of Genesis AEC continue to answer questions on how to validate temperature-controlled... 続きを読む ブログ | Jul 13, 2022 You asked, we answered - Another validation webinar Q&A In this blog, we present questions we didn't have time to answer during our "Ask Me Anything on Validation" webinar. If you haven't yet watched... 続きを読む 事例 Vaisala supports the Sorbonne in environmental research on pesticides Since 2016, the Institute of Ecology and Environmental Sciences (IEES) at the Sorbonne University in Paris has been using the Vaisala Continuous... 続きを読む ブログ | Jun 21, 2022 Controlled Temperature Chamber Validation Webinar Q&A Part 1 In this first of a 3-part series of video blogs, our presenters will answer the questions on validating temperature-controlled chambers. For... 続きを読む ブログ | Apr 29, 2022 Temperature-controlled storage: Can you switch temperature set points seasonally? Vaisala Senior GxP Regulatory Expert Paul Daniel often receives questions about validation. Most questions are common to others in GxP-regulated... 続きを読む ブログ | Apr 25, 2022 GxPモニタリングシステムの優れた導入と長寿命を実現するための3つのポイント このブログでは、ヴァイサラがどのようにviewLincシステムの製品寿命を維持しているのかをご説明します。 続きを読む ブログ | Mar 23, 2022 Guest blog: Temperature mapping studies - Simplifying with validation services What is the current state of how GxP industry performs temperature mapping? Current Good Manufacturing Practice (CGMP), according to the FDA's... 続きを読む 事例 Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies View PDF Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are... 続きを読む ブログ | Mar 5, 2022 Top US hospital ensures regulatory compliance for blood, drugs, vaccines, & nutrition In a US-based hospital recognized as one of the top 10 most innovative healthcare systems for its clinical care and groundbreaking use of... 続きを読む ブログ | Feb 23, 2022 The complex world of compounding labs The American Pharmacist’s Association (APhA) defines compounding as “the creation of a pharmaceutical preparation—a drug—by a licensed... 続きを読む 事例 LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity Photo Source: Lyophilization Services of New England, Inc PDF Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma... 続きを読む ブログ | Jan 20, 2022 マッピング試験の組み合わせ:真空オーブン、倉庫、LN2タンク、CO2 このブログは「継続的なマッピング」のウェブセミナー開催後、いただいたいくつかの質問にお答えします。 続きを読む ブログ | Dec 3, 2021 2021 Best blogs on monitoring & mapping GMP applications The results are in, based on unique web page views, the blogs below were our most popular in 2021. We've also added a few from 2020 that... 続きを読む ブログ | Dec 1, 2021 An introduction to Vaisala viewLinc In the third and final blog post in this series on Modbus we take a look at Vaisala viewLinc, a digital monitoring system that’s especially... 続きを読む ブログ | Nov 19, 2021 FAQ on continuous monitoring systems, building management systems, OPC UA & API In our webinar “Continuous Monitoring Systems & Building Management Systems” we outlined several differences between building management and... 続きを読む
事例 GMP monitoring system brings peace of mind to drug manufacturer The quality of manufactured or processed products at cleanroom facilities are protected by applicable good manufacturing practices (GMP) that... 続きを読む
ブログ | Sep 5, 2023 GxP Temperature Mapping: Acceptance Criteria & Reporting In this blog, Vaisala Senior GxP Regulatory Expert Paul Daniel and validation/commissioning expert Nathan Roman answer questions on validation... 続きを読む
ブログ | Aug 15, 2023 Managing GxP Monitoring System Alarms In this video blog, two validation experts answer questions on best practices for managing alarm functions for monitoring systems in GxP... 続きを読む
事例 Cyto-Facto Inc.: Advancing cell & gene therapies, providing the promise of health In April 2023, Cyto-Facto Inc. (CF), a spin-off of the Foundation for Biomedical Research and Innovation at Kobe, Japan, began manufacturing... 続きを読む
ブログ | Jul 19, 2023 Temperature Mapping Study Design, Duration & Intervals In this video blog, two validation experts answer questions on best practices for mapping study design, including sensor placement, study... 続きを読む
ブログ | Jun 23, 2023 Can you safely copy GxP data? After watching our webinar "GxP data integrity: What you don't know may make you non-compliant", we received an interesting question about... 続きを読む
事例 Accurate environmental measurements in microbiology: Neutral Bioassay Co., Ltd. virus clearance process validation In recent years, a wide range of biological products have been used to create new drugs and therapies. However, the production processes for... 続きを読む
ブログ | May 24, 2023 Intrinsically safe measurements in pharmaceutical hazardous environments Ono Pharmaceutical Co., Ltd. is one of Japan’s largest pharmaceutical companies. Their history goes back to 1717 Osaka and has been known as Ono... 続きを読む
ブログ | May 15, 2023 World Metrology Day 2023: An interview with Heather Wade In this blog, Vaisala Boston Service Center Manager Alberto Benitez interviews Heather Wade, of Heather Wade Group LLC about her recent work as... 続きを読む
ブログ | Mar 18, 2023 Are PDFs secure enough for GxP? This is a question that came up during our webinar on Data Integrity. In this blog, we answer at length. This is a common concern because, with... 続きを読む
ブログ | Mar 8, 2023 Spot-checking measurements of environmental conditions Field spot-checking is a common way to determine the measurement accuracy of a fixed measurement instrument between calibration intervals... 続きを読む
ブログ | Feb 4, 2023 Data Integrity & ALCOA++ principles in GxP continuous monitoring In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we received many questions. Vaisala Senior GxP... 続きを読む
ブログ | Dec 2, 2022 How to time periodic audit trail reviews In our recent webinar “GxP data integrity: What you don't know may make you non-compliant” we had over 480 registrants. With so much interest in... 続きを読む
事例 Science-based skincare benefits from continuous monitoring & efficient validation PDF Established in 2000, Crown Laboratories is a global company that researches, develops, and manufactures skincare products ranging from over... 続きを読む
ブログ | Aug 17, 2022 Part 3 – Final Q&A on controlled temperature chamber validation In this third and final video blog, Paul Daniel and Nathan Roman answer more questions, this time focusing on loaded chamber mapping with empty... 続きを読む
ブログ | Jul 20, 2022 Part 2 - Q&A from our controlled temperature chamber validation webinar In this video blog, Vaisala's Paul Daniel and Nathan Roman of Genesis AEC continue to answer questions on how to validate temperature-controlled... 続きを読む
ブログ | Jul 13, 2022 You asked, we answered - Another validation webinar Q&A In this blog, we present questions we didn't have time to answer during our "Ask Me Anything on Validation" webinar. If you haven't yet watched... 続きを読む
事例 Vaisala supports the Sorbonne in environmental research on pesticides Since 2016, the Institute of Ecology and Environmental Sciences (IEES) at the Sorbonne University in Paris has been using the Vaisala Continuous... 続きを読む
ブログ | Jun 21, 2022 Controlled Temperature Chamber Validation Webinar Q&A Part 1 In this first of a 3-part series of video blogs, our presenters will answer the questions on validating temperature-controlled chambers. For... 続きを読む
ブログ | Apr 29, 2022 Temperature-controlled storage: Can you switch temperature set points seasonally? Vaisala Senior GxP Regulatory Expert Paul Daniel often receives questions about validation. Most questions are common to others in GxP-regulated... 続きを読む
ブログ | Apr 25, 2022 GxPモニタリングシステムの優れた導入と長寿命を実現するための3つのポイント このブログでは、ヴァイサラがどのようにviewLincシステムの製品寿命を維持しているのかをご説明します。 続きを読む
ブログ | Mar 23, 2022 Guest blog: Temperature mapping studies - Simplifying with validation services What is the current state of how GxP industry performs temperature mapping? Current Good Manufacturing Practice (CGMP), according to the FDA's... 続きを読む
事例 Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies View PDF Operating a GxP facility that must comply with regulatory requirements is no simple matter but doing so ensures that products are... 続きを読む
ブログ | Mar 5, 2022 Top US hospital ensures regulatory compliance for blood, drugs, vaccines, & nutrition In a US-based hospital recognized as one of the top 10 most innovative healthcare systems for its clinical care and groundbreaking use of... 続きを読む
ブログ | Feb 23, 2022 The complex world of compounding labs The American Pharmacist’s Association (APhA) defines compounding as “the creation of a pharmaceutical preparation—a drug—by a licensed... 続きを読む
事例 LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity Photo Source: Lyophilization Services of New England, Inc PDF Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma... 続きを読む
ブログ | Jan 20, 2022 マッピング試験の組み合わせ:真空オーブン、倉庫、LN2タンク、CO2 このブログは「継続的なマッピング」のウェブセミナー開催後、いただいたいくつかの質問にお答えします。 続きを読む
ブログ | Dec 3, 2021 2021 Best blogs on monitoring & mapping GMP applications The results are in, based on unique web page views, the blogs below were our most popular in 2021. We've also added a few from 2020 that... 続きを読む
ブログ | Dec 1, 2021 An introduction to Vaisala viewLinc In the third and final blog post in this series on Modbus we take a look at Vaisala viewLinc, a digital monitoring system that’s especially... 続きを読む
ブログ | Nov 19, 2021 FAQ on continuous monitoring systems, building management systems, OPC UA & API In our webinar “Continuous Monitoring Systems & Building Management Systems” we outlined several differences between building management and... 続きを読む