Avantages
- L'enregistrement redondant garantit des données en continu.
Les données sont recueillies par trois canaux indépendants : sur chaque enregistreur, sur le PC hôte et par sauvegardes automatiques. Chaque enregistreur dispose d'une mémoire embarquée et d'une batterie afin que le réseau et les coupures de courant n'entraînent aucune perte de données.
- Mesurez plusieurs paramètres avec le même système.
Surveillance de nombreux paramètres : température, humidité relative, CO2, pression différentielle, lumière, contacteurs de porte, etc. Ajoutez de nouveaux points de contrôle facilement : pas de programmation, pas de sous-traitance, pas de services supplémentaires à acheter.
- Connectivité flexible pour une installation simple et rapide
Se connecte à votre réseau existant (y compris virtuel) via le réseau sans fil, Ethernet ou PoE. L'intégration à votre infrastructure existante permet d'éliminer le coût d'installation et d'entretien d'un réseau dédié. Utilisez le réseau Ethernet, PoE, WiFi ou une combinaison des trois.
- Planification de rapports par e-mail
Gagnez du temps dans la gestion de vos rapports grâce à une personnalisation de ces derniers et une transmission par e-mail planifiée. L'automatisation des rapports archivés et événementiels élimine le risque d'oublier de générer vos rapports. Les rapports d'alarme peuvent être filtrés par Zone, Description de l'enregistreur, Date/Heure et zone de responsabilité.
- Voir Exemple de rapport d'alarme
- Conformité aux normes
Le logiciel et les enregistreurs peuvent être validés pour conformité avec les FDA 21 CFR Partie 11, CBER, GxP, TJC, AATB, AABB et autres organismes de réglementation. La notification d'un étalonnage automatique, un traçage d'audit sécurisé et des données inviolables assurent la conformité.
- Précision supérieure
La meilleure précision du marché à ±1 % HR et ±0,10 °C et une résolution de 0,05 % HR et 0,02 °C (à 25 °C) pour les applications à tolérances serrées.
Autres fonctions :- Affichage des tendances en direct et des données historiques
Afficher les données graphiques en direct depuis un quelconque canal d'enregistreur sélectionné dans une fenêtre contextuelle sur l'interface utilisateur. Afficher également les anciennes données à l'aide d'un générateur de données historiques.
Alarme et transmission personnalisables
Établir les causes les plus fréquentes des alarmes et prendre des mesures pour assurer la cohérence des rapports parmi tous les utilisateurs système. La configuration simple par lots pour les seuils d'alarme vous permet de créer des modèles et de les affecter à plusieurs enregistreurs.
- Les instruments se connectent à leurs environnements
Les enregistreurs sont associés à un Descripteur ou une Zone et, lorsqu'ils sont transférés pour étalonnage (ou toute autre raison), ils retiennent toutes les informations associées : description, seuils d'alarme, retards, transferts, paramètres d'e-mail et commandes d'exécution externes.
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Assistance/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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Exemples d'applications
Pharmaceutique / biotechnologies
Métrologie / électronique
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À propos de Veriteq
Avec l'acquisition de Veriteq par Vaisala au printemps 2010, deux entreprises hautement performantes unissaient leurs forces et consolidaient leur offre de solutions leaders dans le domaine de la mesure, de la surveillance et du test de paramètres environnementaux critiques.
Désormais intégrée à la division Environnements contrôlés de Vaisala, Veriteq garde néanmoins la même mission : offrir les solutions de surveillance, d'alarme et de validation environnementales les plus précises du marché, à destination des secteurs pharmaceutique, biotechnologique, médical, aérospatiale/défense et étalonnage.
En rejoignant le groupe Vaisala, Veriteq s'est allié au leader mondial des mesures environnementales et industrielles. Fort de plus de 70 ans d'expérience, Vaisala contribue à améliorer la qualité de vie grâce à une gamme complète de produits et services innovants pour l'observation et la mesure dans le domaine de la météorologie, des opérations météodépendantes et des environnements contrôlés.
Poursuivant au sein du groupe Vaisala sa quête de qualité, Veriteq continue de développer, d'améliorer et d'enrichir la fonctionnalité de ses principaux produits : le système de surveillance et d'alarme viewLinc et le système de validation vLog. Ces deux solutions haute fiabilité sont conçues pour aider les entreprises régulées à se mettre en conformité avec les bonnes pratiques GxP ou avec les réglementations de la FDA (Food and Drug Administration, agence sanitaire chargée des aliments et des médicaments aux États-Unis), mais aussi les entreprises non régulées soumises à des audits.
L'amélioration continue des produits est un engagement de chaque collaborateur du groupe Vaisala. Veriteq comme Vaisala sont réputés pour leur sensibilité exceptionnelle aux besoins de leurs clients. Cette vision partagée du service comme première priorité permet aux deux partenaires de proposer des solutions et des services sur lesquels les clients peuvent compter.
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Protocoles disponibles
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Notre protocole de validation est un ensemble complet de procédures d'essai et de listes de contrôle prédéfinies pour la validation système, ainsi que l'installation et la qualification opérationnelle. Imprimé et fourni avec classeur et CD. Documents au format Microsoft Word pour faciliter la personnalisation. Afficher un exemple QI/QO.
Le kit comprend des procédures, formulaires et modèles de qualification d'installation (QI) et de qualification opérationnelle (QO) : tout ce dont le personnel de validation a besoin pour documenter en détail le bon fonctionnement du système.
Qu'est-ce qu'un protocole de validation ?
Les protocoles de validation sont spécifiés dans votre plan directeur de validation.
Le plan directeur de validation (PDV ou VMP pour Validation Master Plan) décrit l'organisation d'ensemble du projet de validation, notamment la chronologie, les responsabilités et la méthodologie. Il peut porter sur la qualification d'un nouvel équipement ou environnement, mais aussi sur la validation d'un produit ou d'un processus. Les éventuelles validations logiciel/réseau y figurent également.
Le PDV est un document interne visant à systématiser la validation au sein de votre organisation. L'opportunité d'élaborer un PDV dépend de la taille, de la fréquence et de la complexité de vos projets de validation.
En revanche, vous aurez toujours besoin de protocoles de validation. Le protocole de validation Veriteq de Vaisala est conçu pour contrôler les performances des enregistreurs de données température et humidité relative VL-1000, VL-1000-VLT et VL-2000. Il facilite également la validation du logiciel Veriteq viewLinc de Vaisala dans le cadre de votre exploitation. |
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Pour en savoir plus
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- Comment remplir (et éviter) un formulaire 483 de la FDA (pdf, 534KB)
- How to Respond to FDA 483 Warning Letters (pdf, 564KB)
- Measure Monitor and Validate in Life Science Environments (pdf, 456KB)
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- Vaisala Veriteq Continuous Monitoring System Brochure (pdf, 1449KB)
- 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)
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- Research Hospital Preserves Vaccines During Power Failure.aspx (aspx, 3KB)
- 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)
- 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)
- 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)
- Vaisala Veriteq Monitoring System 21 CFR Part 11 Compliance White Paper (pdf, 242KB)
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