特長
- 欠損のないデータ記録
データ収集は独立した3つの方法（データロガー、ホストPC、自動バックアップ）で行われます。
- 適応性と拡張性
温度、相対湿度、CO2、差圧、光度、ドアスイッチなどのパラメータのモニタリングが可能です。新たなモニタリングポイントも簡単に追加でき、特別なプログラミングやアウトソーシング、追加サービス購入の必要はありません。
- フレキシブルな接続性
大規模なシステムから単体のアプリケーションにまで対応した最適の接続性で、ワイヤレスまたはLANケーブルを使用した温度モニタリングのニーズに応えます。既存のネットワーク環境を使用できるため、専用ネットワークの構築やその保守管理にかかるコストを節約できます。お客様ご使用のイーサネット、PoEまたはWiFiネットワークか、それらを組みわせて使用可能です。
- Eメールによる定期的なレポート
Sレポート作成の手間を節約できます。履歴やイベントのレポートが自動で作成され、スケジュールどおりにお客様のEメールへ送信されます。レポートの作成を忘れないようにする必要がありません。
- 厳しい基準に対応
21 CFR Part 11（連邦規則第21条第11章）、生物学的製剤評価研究センター（CBER）、国際適正基準（GxP）、医療施設認定合同委員会（JCAHO[原文のJHACOはJCAHOの誤りでは？また、ファイル594のように現在はTJCのようです。（日本語名称は「合同委員会」だけではわかりにくいので元のままにしました）]）、米国組織銀行協会（AATB）、米国血液バンク協会（AABB）などの医薬品温度モニタリング等に関する規制要件に準拠できるよう、ソフトウェアとロガーに検証機能が付いています。
- 優れた精度
業界最高の±1％RH、±0.10ºCの精度と0.05％RH、25ºCにおいて0.02ºCの分解能で許容範囲内でのオペレーションを確かなものにします。
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サポート FAQ
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How do I uninstall a Vaisala Veriteq USB Logger Cable? » To uninstall the Vaisala Veriteq USB Logger Cable, please go to Add or Remove Programs in Windows, find FTDI USB Serial Converter Drivers and click the Change/Remove button. Follow the uninstall wizard as prompted to complete the uninstallation.
Notice for Windows XP users:
If you are experiencing problems uninstalling the cable on Windows XP, this may be due to changes made by a Microsoft Update (KB923191). To correct this problem, please follow the directions below:
- Navigate to C:\Windows\system32
- Locate the ftdiunin.exe file
- Right-click the file and select Properties
- Select the Compatibility tab
- In the Compatibility mode section, place a check in the Run this program in compatibility mode for: box
- Select Windows 2000 from the drop-down list
- Click OK
- Go back to Add or Remove Programs and attempt to uninstall again
If you are still unsuccessful, please contact Technical Support.
How do the FDA CFR 21 Part 11 requirements relate to the VL Data Logger system? » The CFR 21 Part 11 regulations apply to any electronic records that are used as a part of GMP documentation, including the ones produced by the Vaisala VL-series data logging system.
CFR 21 Part 11 Requirement |
Reference |
VL-Series Features |
| All records shall be prepared, dated and signed (full signature, handwritten) by one person and independently checked, dated and signed by a second person. |
GMP 211.186 |
Password-protected system outputs paper-based records with appropriate form for review and approval sign-offs. |
| Electronic records may be considered trustworthy and reliable and be used in lieu of paper records provided that the electronic records have proper security controls |
CFR 21 Part 11; Subpart A-Sec 11.1 Scope |
Software produces secure and encrypted electronic records that are used to produce printed documentation. Software recognizes invalid or altered data logger files and renders them unusable |
| Ensure the authenticity and integrity of the electronic records such that the person responsible for the electronic record cannot readily repudiate the record as not genuine |
CFR 21 Part 11; Subpart B-Sec. 11.10 |
Tamper-proof data logger (no switches or buttons). Password-protected calibration record verifies integrity of recorded data. Password protection ensures that person who created electronic record is the same person who outputs a paper record |
| Ensure that the system can discern invalid or altered electronic records |
CFR 21 Part 11; Subpart B; Sec. 11.10 (a) |
Software recognizes invalid or altered data logger files and renders them unusable |
| Ensure that complete and accurate records in both human readable and electronic form are available for review and inspection by the FDA |
CFR 21 Part 11; Subpart B; Sec. 11.10 (b) |
Original raw electronic record is never modified and can be printed for review and inspection |
How does the Continuous Monitoring System and VL data loggers produce GMP-compliant records? » The VL-series data logging system is a set of monitoring tools that have been designed for use within the framework of a company's GMP-compliant record-keeping and documentation system. The system produces paper-based data logging records that, after signed review and approval by responsible parties, can be used in a GMP-compliant documentation package. As a part of this process, the VL-series system creates and uses secure and unalterable electronic records consistent with GMP requirements for authenticity and accuracy.
How long can Vaisala Veriteq data loggers record for? »
The length of time Vaisala data loggers can record for is determined by the number of input channels enabled on the logger, the recording frequency (sampling interval), and the size of the memory (32K or optional 105K).
Vaisala data loggers can, for example, record data continuously for 10 years (at a typical sampling rate of once per minute) without any need for a battery replacement. For a typical two-channel data logger that's over 10 million non-stop readings.
For a general guide, refer to the Sample Interval & Duration Chart or refer to the specifications page for the specific data logger model you are interested in.
How do I run an External Digital Relay I/O device as part of my viewLinc alarm system? » In addition to email alarms and pop up windows, you can also run commands on the viewLinc Server machine (which in turn can trigger external devices) when an alarm threshold is exceeded.
To configure these:
In the Advanced area of the Edit Thresholds Settings screen, enter a DOS command in the appropriate box. There are different boxes to accept different commands for when an alarm is triggered, notification is repeated, alarm acknowledged, or alarm condition is no longer true.
You may be using a B+B Electronics External Digital Relay I/O Device. This device allows you to turn on two different devices (or both at the same time) if these devices are correctly wired to both power and the Digital Relay Device itself.
You must also attach the Digital Relay I/O Device to a COM port on the viewLinc Server.
The specific DOS command to enter in the viewLinc Edit Threshold Settings screen in viewLinc 3.0 when using the B+B External Digital Relay I/O device and the python SwitchBbRelay script (installed automatically as part of viewLinc 3.0) is:
python SwitchBbRelay.pyc <COM port to which the relay device is attached> <Option> where Option is one of:
1 – turn on Device 1
2 – turn on Device 2
3 – turn on both Device 1 and 2
0 – turn off both Devices. How do I stop communication alarms? » 1. Ensure your loggers are plugged in.
2. Ensure your Digi is connected to a power supply and the power supply is plugged in. The light on the front of the Digi should be solid red.
3. Ensure the Digi is connected to and communicating with the network. Try to ping the Digi by typing the following at a command prompt: ping <IP address of the Digi>.
4. If there is communication between the Digi and the network, check that the Verieq-supplied cable connecting the logger to the Digi is functioning properly. When the cable is functioning properly, the light should be mostly off with an occasional flicker. If the light on the cable is solid red, there is a problem with the logger cable or logger. See step 6.
5. If the light on the cable is working correctly but you are still getting communication alarms, go into Device Manager on the viewLinc Host computer and ensure the Digi is still installed. Under the Ports category in Device Manager, you should see an entry for Digi SP One. If you don’t see this, reinstall the Digi by following steps 2 B and C from the Quick Start Guide for viewLinc with Digi Devices.
6. If the light on the cable is not working properly, open a graphing application (vLog or Spectrum) and determine if the logger can communicate with the graphing application. If there is a problem with the logger communicating with the graphing application, it is likely the logger or logger cable is not functioning properly. Try connecting a new logger – or a logger that is known to be working – and see if you can connect to it in vLog or Spectrum.
Which COM ports is my Digi device using? » There are two easy ways you can check to see which COM ports are associated with which Digi Device. Both include accessing the Device Manager in Windows.
Open Device Manager (From Start, choose Settings, Control Panel, Administrative Tools, Computer Management. Device Manager is on the left hand side).
Once Device Manager is open, click on Ports (COM & LPT) to see which COM ports are connected to which devices. (The Digi Devices should be named Digi xxxxx (where X is the model of the Digi).
The next option (for more detail), is to go to Device Manager (Start, Settings, Control Panel, Administrative Tools, Computer Management, Device Manager is located on the left hand side), and, under Multiport serial adapters, right-click the device in question. Choose Properties, select the Advanced tab, click on the properties button. On the left will be a list of the COM ports used for this device.
What if I cannot communicate with the logger(s) connected to my Digi device? » If you cannot communicate with loggers attached to a Digi device using Vaisala Veriteq software, there may be a problem with the way the Digi is configured.
Please check the folowing, retesting communication after each step:
- The Digi device is plugged in to your network and powered on;
- A logger is attached to the Digi device;
- The RealPort driver has been installed. There should be a listing for a Multiport Serial Adaptor with the IP address of your device in Device Manager. There should be a listing for one or more Digi RealPorts under the Ports (COM & LPT) heading in Device Manager. If the driver has not been installed, perform step 5 on the Digi Setup Page (see instructions for viewLinc)
Make sure the Veriteq software is configured to communicate with the correct COM port (see the Ports (COM & LPT) section in Device Manager). In Spectrum or vLog go to Tools>Options and select the correct COM port from the drop-down menu.
If things still don't work, reconfigure the Digi device using the instructions below:
1.Enter the IP address of the device into a web browser
2.Enter the username and password at the login screen (the defaults are root and dbps).
3.Once you are logged in, click on the Setup Wizards link
4.Click on the RealPort link
5.Follow the wizard, enabling RealPort and NOT enabling Altpin
6.Click on the Admin link
7.Click on the Reboot link and follow the wizard to reboot
If you still cannot communicate with the logger, it may be due to a problem with the RealPort driver installation. During the installation there is a step that asks you to enter the number of serial ports. This refers to the number of physical ports on the Digi device, not the COM port number that you want to allocate to the device (eg. for a Digi One RealPort you would enter 1, for a Digi PortServer TS4 you would enter 4). If the incorrect number is entered here, it is quite likely that you will not be able to communicate with a logger attached to the device.
To fix this problem, uninstall the drivers by right-clicking the listing for Multiport Serial Adaptor in Device Manager and selecting Uninstall. One the uninstall is complete, reinstall the driver ensuring that you specify the correct number of ports. What if the Digi Setup Wizard cannot save settings to the Digi device? » When going through the Digi Setup Wizard, if the you get a message stating that it cannot save the settings to the device even though the device is visible in the discovery portion of setup (and also responds to a ping), then it might be a problem with proxy settings on the your internet connection. This might also prevent you from logging in to the device's web interface.
One way to check if you connect to the Internet through a proxy server:
1.In Internet Explorer, go to Tools>Internet Oprtions
2.Click on the Connections tab
3.Click on the LAN Settings button
4.See if there is a check mark in Proxy Server box
If you are using a Proxy Server, you may have to add exceptions for the IPs that the Digi devices are using. Here's how to do that:
1.Click on the Advanced button in the Proxy Server section of the window opened above
2.Enter the IP addresses of the Digi devices in the Exceptions box
3.Click OK on all of the windows until you get back to the browser
Once this is done, try to log into the Digi's web configuration utility (by entering the IP address into a browser).
If you are able to log in (the default username / password is root / dbps), then configuration can be done through this interface as below:
1.Click on the Setup Wizards link
2.Click on the RealPort link
3.Follow the wizard, enabling RealPort and NOT enabling Altpin
4.Click on the Admin link
5.Click on the Reboot link and follow the wizard to reboot
The Digi device is now configured. The RealPort driver has not been installed yet, so do not forget this step. To install the RealPort Driver, perform step 5 on the Digi Setup Page (see Vaisala Veriteq CMS Installation Quick Start Guide). These steps must be repeated for each Digi device.
What if the Digi Setup Wizard does not see my Digi devices? » The Windows XP firewall will often block IP addresses that it does not recognize. When installing a Digi device, if the Setup Wizard fails to find a device that is known to be attached to the network, it is possible that the firewall of the local computer is blocking access to this IP address. To test if this is the problem, simply disable the firewall by following these steps:
1.Right-click My Network Places and select Properties
2.Right-click Local Area Connection and select Properties
3.On the Advanced tab, click the Windows firewall button
4.Disable the firewall and click OK
Once the firewall has been disabled, try to run the Setup Wizard again. If it discovers your device then the XP firewall was the problem. Complete the rest of the wizard to finish installing your device. The firewall can be re-enabled after the Digi device has been installed. How does viewLinc know which Digi devices (with attached loggers) are assigned to it? » It doesn't. Digi devices aren't 'assigned' to viewLinc; rather, viewLinc monitors the network for loggers attached to COM ports. As mentioned, viewLinc software communicates via COM ports. Installing a Digi device using the Quick Start Guide creates virtual COM ports which are monitored by viewLinc.
To see which COM ports are assigned to specific Digi devices, use Device Manager:
Open Device Manager (From Start, choose Settings, Control Panel, Administrative Tools, Computer Management. Device Manager is on the left hand side).
Once Device Manager is open, click on Ports (COM & LPT) to see which COM ports are connected to which devices. (The Digi Devices should be named Digi xxxxx (where X is the model of the Digi).
For more detail, in Device Manager, under Multiport serial adapters, right-click the device in question. Choose Properties, select the Advanced tab, and click on the properties button. On the left will be a list of the COM ports used for this device.
To see which loggers are being controlled by viewLinc, see the System tab. How do you add IP addresses for Vaisala Veriteq data loggers? » You don't. But, you do assign IP addresses to Digi devices. Because viewLinc communicates using COM ports, attaching data loggers to the network using Ethernet/IP addresses requires the use of a Digi networking device.
Digi devices create virtual COM ports that allow data loggers to communicate with viewLinc using Ethernet. Digi devices should be configured with static IP addresses, which should be obtained from your IT department prior to installing the Digis and viewLinc.
IP addresses are assigned to Digi devices during Digi driver installation.
Refer to the Vaisala Veriteq viewLinc Quick Start Guide for Digi devices for installation instructions. For more about Digis, see www.digi.com. How do I move my Digi from one location to another (same subnet)? » If you've used a static IP address for your Digi (as recommended) and are moving your Digi to from one location to another within the same subnet, here are the steps to follow:
1. Shut down all Vaisala Veriteq software, if desired. (You may experience communication alarms while performing these steps if you don’t shut down viewLinc).
NOTE: You do NOT need to uninstall the Digi software from the viewLinc Server. In fact, doing so will potentially cause problems when you reattach the Digi to the network.
2. Move the Digi to another location.
3. Plug the Digi into the network again.
4. Restart Veriteq software. viewLinc should be connecting to the Digi and see the loggers.
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Application Examples
Pharma / Biotech
Metrology / Electronics
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About Veriteq
Veriteq was acquired by Vaisala in the spring of 2010, consolidating two high performance companies to provide a broader range of industry-best solutions for measuring, monitoring, and testing critical environmental parameters.
Now part of Vaisala's Controlled Environments division, Veriteq's original focus remains today: providing the most accurate environmental monitoring, alarming and validation solutions to the pharmaceutical, biotechnical, medical, aerospace/defense and calibration industries.
In joining the Vaisala Group, Veriteq has combined forces with the global leader in environmental and industrial measurement. Building on more than 70 years of experience, Vaisala contributes to a better quality of life by providing a comprehensive range of innovative observation and measurement products and services for meteorology, weather critical operations and controlled environments.
Vaisala retains Veriteq's original commitment to quality and continues to develop, improve and broaden the functionality of its main offerings: the viewLinc Monitoring and Alarming system and the vLog Validation system. Both solutions are highly reliable and designed to meet the demanding needs of GxP/FDA regulated customers and non-regulated organizations that are subject to audit.
Every member of our team is committed to continual product improvement. Both Veriteq and Vaisala are known for our exceptional responsiveness to our customers' needs; our shared value of customer service as a first priority make us the ideal partnership in providing our customers the finest solutions and service they can rely on.
For more information, contact us here. |
利用可能なプロトコル
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当社のバリデーションプロトコルは、据付時適格性確認（IQ）および稼動性適格性（OQ）に関するシステムバリデーション用試験ガイドラインおよびチェックリストで構成され、CDが付属しています。ドキュメントはカスタマイズしやすいようにMicrosoft Word形式で作成されています。 View sample IQOQ.
パッケージはカスタマイズ可能な据付時適格性確認（IQ）および稼動性適格性確認（OQ）の手順内容、フォームおよびテンプレートで構成され、バリデーション担当者はシステムの適正運転の確認に必要な詳細事項を記録することができます。
バリデーションプロトコルとは？
バリデーションプロトコルとは、お客様のバリデーションマスタープラン（基本計画：VMP）の中で参照していただくプロトコルです。
VMPは、スケジュール、担当、方法などバリデーション業務全体の概要を示したものであり、新しい機器や環境のバリデーション、あるいは製品やプロセスのバリデーションというように目的を特化することもできます。ソフトやネットワークのバリデーションも対象となります。
VMPは、バリデーションのシステム化を目的としてお客様の組織で作成される内部資料です。VMPの必要性は、お客様のバリデーション業務の規模、頻度、複雑さ等によって決まります。
それに対して、どのような場合にも常に必要となるのがバリデーションプロトコルです。ヴァイサラVeriteqバリデーションプロトコルは、VL-1000／VL-1000-VLT／VL-2000温度・相対湿度データロガーの性能検証ならびにお客様の施設でご使用のヴァイサラ Veriteq viewLincソフトウェアのバリデーション支援を目的として作成されています。 |
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詳細については
- Calibration Lab Monitoring and Alarming.aspx (aspx, 3KB)
- Freezer Temperature Monitoring and Alarming.aspx (aspx, 3KB)
- Comment remplir (et éviter) un formulaire 483 de la FDA (pdf, 534KB)
- How to Respond to FDA 483 Warning Letters (pdf, 564KB)
- Wie-reagiere-ich-auf-und-vermeide-Formblatt-483-der-FDA? (pdf, 566KB)
- ヴァイサラライフサイエンス 環境モニタリングシステム参入 (pdf, 1335KB)
- 如何应对（和避免）美国食品药品监督管理局 （FDA）的483检查表 (pdf, 793KB)
- Dienstleistungs- & Supportangebote für Vaisala Veriteq Überwachungs- und Validierungssysteme (pdf, 431KB)
- Measure Monitor and Validate in Life Science Environments (pdf, 456KB)
- Mesurer, assurerle monitoring & valider dans les environnements des sciences de la vie (pdf, 509KB)
- Système de surveillance en continu Vaisala Veriteq Fiche technique (pdf, 1562KB)
- Vaisala Veriteq CMS Service and Support Plans - North America (pdf, 190KB)
- Vaisala Veriteq CMS Service et Offrir un Soutien EMEA (pdf, 436KB)
- Vaisala Veriteq Continuous Monitoring System Brochure (pdf, 1449KB)
- Vaisala Veriteq Kontinuerligt övervakningssystem (pdf, 1699KB)
- Vaisala Veriteq olosuhdevalvontajärjestelmä esite (pdf, 1938KB)
- ヴァイサラVeriteq環境モニタリングシステム (pdf, 2909KB)
- 维萨拉Veriteq连续监测系统 (pdf, 1680KB)
- Avoiding FDA 483 Letters - Published in The Chemical Engineer (pdf, 2505KB)
- Continuous Monitoring Systems - You Can Have it All (Pharmaceutical Processing) (pdf, 303KB)
- Thermistors-Thermocouples-Matching-Tool-to-Task_Journal-of-Validation-Technology (pdf, 104KB)
- Guide de démarrage rapide pour viewLinc 3.6 avec des périphériques en réseau (pdf, 1111KB)
- Vaisala Veriteq Continuous Monitoring System IT FAQ (pdf, 153KB)
- Vaisala Veriteq Datalogger 10 Minute Installation Guide (pdf, 555KB)
- viewLinc_3-6_Quick_Start_Guide (pdf, 3659KB)
- ネットワークデバイスを活用する際のviewLinc3.6クイック スタート ガイド (pdf, 3606KB)
- 配有网络设备的 viewLinc 3.6快速入门指南 (pdf, 3462KB)
- Teledyne Increases Cleanroom Integrity with Continuous Monitoring System.aspx (aspx, 3KB)
- Research Hospital Preserves Vaccines During Power Failure.aspx (aspx, 3KB)
- Lagerüberwachung: Unternehmen für medizinischchirurgisches chirurgisches (pdf, 347KB)
- Success Story: Medical Surgical Supply Company Increases Compliance (pdf, 2447KB)
- viewLinc-3.6-ReleaseNotes (txt, 49KB)
- CMS-Common-Configurations-EN (pdf, 972KB)
- Configurations habituelles du Système de surveillance en continu (pdf, 1000KB)
- Vaisala Veriteq kontinuierliches Überwachungssystem – Konfigurationsmöglichkeiten (pdf, 999KB)
- Guide de L'Adminisrateur viewLinc 3.6 (pdf, 1551KB)
- GUIDE DE L'UTILISATEUR viewLinc 3.6 (pdf, 1032KB)
- viewLinc 3.6 Admin Guide (pdf, 3143KB)
- viewLinc 3.6 User Guide (pdf, 1339KB)
- ユーザーガイドヴァイサラveriteq viewLinc 3.6 ソフトウェア (pdf, 398KB)
- 用户指南-viewLinc-3.6 (pdf, 460KB)
- 管理员指南-viewLinc-3.6 (pdf, 1290KB)
- 管理者ガイドviewlinc-3.6 (pdf, 1273KB)
- Monitoring Critical Conditions for Quality and Compliance (pdf, 552KB)
- Three Keys to Managing the Calibration Lab Environment.aspx (aspx, 2KB)
- Reliable Facility Monitoring with Networked Temperature and Humidity Data Loggers.aspx (aspx, 3KB)
- Is Your RH System Safe? (pdf, 32KB)
- LSH Independent Monitoring White Paper (pdf, 179KB)
- Monitoring-Systems-Sorting-Out-Wireless (pdf, 6129KB)
- Switching From Chart Recorders to Data Loggers (pdf, 131KB)
- Systèmes de monitoring: démystifier le sans fil (pdf, 2210KB)
- Überwachungssysteme: Drahtlos vernetzt (pdf, 1276KB)
- Vaisala Veriteq Monitoring System 21 CFR Part 11 Compliance White Paper (pdf, 242KB)
- モニタリングシステム/ワイヤレスの選定 (pdf, 2733KB)
- 对于FDA监管环境中的连续监测系统，您需要了解的九件事 (pdf, 1107KB)
- 监测系统 - 无线方案甄选 (pdf, 2340KB)
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