安定性チャンバーのモニタリング
ヴァイサラの安定性試験槽モニタリングソリューションは、柔軟性に優れたアラーム機能とカスタマイズ可能なレポート作成機能を備え、独立したリアルタイムトレンドとオーディットトレイルを提供します。ヴァイサラは、温度や相対湿度などの重要パラメータのモニタリングに関するEU医薬品規制調和国際会議（ICH）や米国食品医薬品局（FDA）の要件への違反のリスクを軽減します。
ヴァイサラviewLinc連続監視システムは、以下を提供します：
- 業界トップのデータロガーと計測器
- 簡単なセットアップ、または取り付けと検査サービスによって、所有コストを低減
- 最大数千までのモニタリング場所の拡張性
- GxP標準と規則を遵守し、欠損のない保護されたデータ記録
- SMS、Eメールおよび他のアラートメカニズムによる24時間365日のリモートアラーム
- ユーザー設定によるレポートは、時間設定ができ、Eメールにより自動的に配信されるか、要求に応じて作成され、操作/解析用のデータにエクスポート可能
- コンプライアンスのための、迅速で簡単なIQOQ（サンプル）とGxPの文書化
- さまざまなスポットチェック用ハンドヘルド式湿度・温度計
関連製品
viewLinc 環境モニタリングシステム
ヴァイサラの環境モニタリングシステムは総合的なソリューションで、データロガー、viewLinc 5.0...
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
関連事例
Blog
| Jun 4, 2019
How to Control Humidity Accurately in a Rapidly Changing Environment
Rapidly changing environments are always a challenge for humidity control. This is especially true in applications where relative humidity is...
Blog
| May 16, 2019
Field Comparison of Hydrogen Peroxide Measurement Systems for Isolators
Founded in 1994, Ardien Consulting Services provides isolator validation for equipment used in aseptic manufacturing, sterility testing and...
Blog
| Mar 5, 2019
Give Your Climate Chamber a Boost
The requirements for testing different products, materials, and components can vary a lot depending on their intended application and other...
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...
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...
Blog
| Oct 25, 2018
Relative Humidity – What Is It And Why Is It Important?
The basics Put simply, relative humidity (RH) is a measure of the water vapor content of air. More explicitly, it is the amount of water vapor...
Blog
| Jul 30, 2018
Gaining In-depth Understanding of the Problem is The Key - Millennium Technology Prize Winner Tuomo Suntola interviewed
Doctor Tuomo Suntola, who this spring received the prestigious 2018 Millennium Technology Prize for his technology of atomic layer deposition...
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...
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。
Blog
| 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...
Blog
| 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...
Blog
| Nov 17, 2017
Vaisala Cleanroom, At the Origins of Reliable Sensors
Would you like to have peek inside Vaisala cleanroom? It’s one of the most secret places in Vaisala, yet you will now have a chance to have a...
Success Story
McKesson Specialty Health Achieves over 100 Audits without a Single Observation
Bullet-proof environmental monitoring technology that answers auditors’ questions. McKesson Corporation, currently ranked 5th on the FORTUNE 500...
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...
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...
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...
Blog
| Mar 28, 2017
Q&A from our recent 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...
Blog
| Feb 25, 2017
4 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. But first - make sure you don...
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...
Blog
| Oct 22, 2016
Loaded Room Studies for Performance Qualification: Can We Just Say No?
Hello, I recently watched your webinar "Modern Rules for an Old Practice: Sensor Placement for GxP Temperature Mapping" and found the...
Success Story
Strong in Extreme Conditions
Environmental test chambers - investigating product durability Arctest is a Finnish company that develops environmental test chambers and rooms...
Blog
| Jul 18, 2016
Cold/Hot Spots: How Many Probes Are Really Needed for Stability Chamber Monitoring?
We recently received a question about placing temperature and humidity probes for monitoring stability chambers, based on where the hot and cold...
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......
Blog
| Apr 28, 2016
Out of Tolerance Temperatures: How long before you Decommission a Storage Area?
Dear Paul, We recently mapped a warehouse expecting it to be between 20˚C - 25 ˚C. Instead we found a number of temperature probes out of range....
Blog
| Apr 9, 2016
Video Tour of our Cleanroom & Join us for a Free 1-hour Webinar on Mapping Studies
We invite you on a brief video tour of our cleanroom in Helsinki, Finland. Join Hannu for a quick peek into the Vaisala cleanrooms that are, in...
Blog
| Mar 20, 2016
Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Japan & GAMP for Monitoring Systems
Recently our Regulatory Expert Piritta Maunu gave a training session on Annex 15 in Japan and was asked this question: "Regarding qualifying...
Blog
| Feb 29, 2016
AstraZeneca Increases Efficiency with Continuous Monitoring System
Astra Zeneca is a global, science-led biopharmaceutical business and is one of the handful of companies to span the entire life-cycle of a...
Blog
| Feb 20, 2016
Mapping Sensor Placement in Stability Chamber Manufacturing
In this week's blog Paul Daniel answers a question on mapping sensor placement from a stability chamber manufacturer: Dear Paul, We design and...
Blog
| Jan 29, 2016
Three Fundamental Elements of 21 CFR Part 11 and Annex 11
Along with providing monitoring and validation systems, we often delve into issues that arise for our customers when they are interpreting...
Blog
| Jan 20, 2016
Most-Read Blogs of 2015
As we have done in years past, we open the New Year with the top blogs from last year. Check out our other "best-of" blog round-ups from 2013...
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。