Can you do a quote example forRFL, DL and WIFI range systems? Janne Halonen We are based in Helsinki, Finland with over 1600 employees. Data is protected within the system with multiple points of redundancy (data logger, server, database backup so that no single point of failure can cause data loss. Ive always loved Bluetooth for personal use. The software is designed to be intuitive and easy to-use, so less time is spent on learning and training users to the system. User-selectable: Wrap when memory full (FIFO), or Stop when memory full. Can the GMP251 be used during high heat sterilization? The process of Validation and Qualification is important to our GxP customers because it is a regulatory requirement for pharmaceutical and medical device manufacture in most countries, especially for those companies looking to export to the USA or Europe. A complete solution, our mapping tools eliminate costly downtime from pre- and post-calibration and deliver accurate, validatable results. If you attempt to sell viewLinc based on price alone, you will likely have little success viewLinc is rarely the cheapest option. "J03v3000 @\88 How does viewLinc deal with sites in different Time Zones? /MediaBox [ 0 0 595.27563 841.88977 ] Cost of Deployment: Some customers are concerned about the time and cost to deploy the viewLinc system, or need to get the system deployed quickly. <> Vaisala's humidity and temperature validation solution is the easiest, most cost-effective method for mapping equipment, areas, and systems in FDA regulated and GxP environments. The cabinets small footprint and the fact that its pre-configured make it very convenient. Because the swap was like for like, using the same model data logger, no change control testing is needed. If that isnt enough, the user can immediately access the Help menu, or directly email Technical Support from a link within the Help. +2 +60 C (+35.6 +140 F) with alkaline batteries, -20 +60 C (-4 +140 F) with lithium batteries, Screws, tie-wrap, hook, or magnetic mounting bracket (optional accessory), 30 s/month Synchronizes with Network Time Protocol (NTP) server, Integrated high-accuracy capacitive polymer RH sensor, +/-1%RH over 10%RH to 90%RH at +20C to +30C, +/-2%RH over 10%RH to 90%RH at -20C to +70C, +/-3% RH over 10% RH to 90% RH at -20C to +70C. viewLinc includes special organization tools, called Templates, to control the administrative burden. Daniel Gabrault has been a plant engineer with LSNE for over three years. I like that I can see whats happening in our facility out in Wisconsin from my location in New Hampshire. /ProcSet[/PDF/Text/ImageC] For more information, refer to the viewLinc User Manual Section 1.3.2 Watch a Tour [see Additional viewLinc Resources at end of this document], Kwa-Zulu Natal (Head Office) Here is a list of what is possible: What parameters can the system measure and store? It was important to us to have as much environmental data as possible in one system, says Gabrault. IT Integration and Adaptability: Some customers are concerned with the integration of the viewLinc system within their IT solutions. endobj The viewLinc software can be installed on almost any type of server. Gabrault was able to further streamline the documents for simplicity. Vaisala This process is called a swap. Templates basically allow an administrator to reuse an efficient solution multiple times do decrease their workload. Data recording capabilities include accurate time-based readings up to six times per minute, for durations lasting up to several years. To ensure the highest level of quality to client companies and patients, LSNE must undergo regulatory inspections from multiple agencies and host numerous client and Qualified Person audits. x Vaisala also keeps multiple GxP and Regulatory Experts on staff dedicated to supporting our GxP customers in maintaining the required validation documents for their viewLinc installation. [ 201 0 R /Fit ] no ; but you are authorized to sell it with a CMS case. How do we support qualification and validation? 142 JB Marks Road One sample / channel / minute (nonchangeable). cas)f?Nxq$". !Q 4. And while standard Bluetooth wont have many GxP applications beyond networking your personal devices, BLE might just find some inroads into GxP, in specific roles that match the capabilities of the technology. Vaisala calibrations are performed in accredited labs (ISO 9001, 14001, and 17025) with NIST traceable references, and can be done with custom calibration points. What does that mean? endobj We can support customers that want to calibrate instruments themselves, by providing the necessary software utility programs and reference instruments. When not supporting validations, our GxP Experts are busy ensuring that Vaisala maintains their position as a thought leader in monitoring compliance with regular webinars and seminars for our customers. Vaisala also provides calibration options to ensure sensors maintain their accuracy, including: Vaisala service center calibration, probe replacement service, or software and equipment for in-house calibration. Yes. TqN!Z 0&3)PA@[|rYD($ \@ (xB.J@@Ecxda'D2R:MeF[Bdh%InS$0pIdq3>H&Zpt( ZVk This regulatory scrutiny necessitates that the companys Quality Systems are current, compliance focused, and continuously updated. For example, loggers will continue to collect and store data even when disconnected from the system. +46 40 298 991 endobj This can be overridden if desired. The viewLinc software was designed to be easy to learn. What is a typical use of the viewLinc system? Vaisala is a global leader in weather, environmental, and industrial measurements. The RFL100s also have a digital display, so we can quickly check conditions and see whether the device is working properly.. Currently most alarms are sent by email, but weve also set up important alarms to go directly to phone, says Gabrault. Douglasdale, Sandton, Please fill in this form and we will get back to you soon, Region * For more information, refer to the viewLinc User Manual Section 10.7 Swap Devices [see Additional viewLinc Resources at end of this document]. forsaljning@vaisala.com. Some were using chart recorders, or other legacy systems. Can a customer import data from an older version of viewLinc? There are multiple approaches to selling viewLinc. /PageLayout/SinglePage There is a single license fee based on the number of sensors, not the number of users, so license cost is always managed at a level that matches the level of deployment. Does theGMP231 only work with Indigo? Lyophilization Services of New England, Inc. uses Vaisalas viewLinc system to monitor multiple environments, including walk-in or reach-in freezers and refrigerators, and cleanrooms. Its helpful to think of the system in five parts: Sensors, Data Loggers, Ethernet Adaptors, Device Host Servers, and the viewLinc Server. no, if network is the same only one server using web application capabilities ; see also : 13. The system will continue to collect data from the connected sensors, even if one sensor is offline. Connectivity options provide an easy, scalable network capability using Ethernet and/or WiFi for remote and centralised monitoring, real-time data display, data redundancy and email alarms. This allows administrators and users to receive remote alarms for areas under their care. /Contents[ 202 0 R] The software recognizes the language settings used in the client PC, and presents the viewLinc interface in the local language by default. This means that when you upgrade to a new version of viewLinc, you can bring your legacy data into the new system, and continue to use your existing sensors. /Type /Catalog /Pages 59 0 R << RS-232 serial, USB, Ethernet, PoE, WiFi network interface available. Also, if the system goes down and you dont receive a notification, its very frustrating. For more information, refer to the viewLinc User Manual Section 2.7 Validate Your System [see Additional viewLinc Resources at end of this document], Ethernet Cable via Digi MultiPort Adaptor, VaiNet Long Range RF Protocol (over 100M range indoors), Vaisala Intrinsically Safe Sensors (Explosion Proof). That can mean extra effort to set them up.. Alarms and Notifications: Some customers are concerned about receiving timely alarms and notifications from the viewLinc system. Required fields are marked *. viewLinc can run as virtual server in your own private cloud. We expect the new RFL100 data logger to become the standard tool for mapping warehouses. 3. /CS1 242 0 R >> The Vaisala viewLinc system is designed with the idea that it can virtually deploy itself. Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma Services) is a contract development and manufacturing organization (CDMO) that serves global pharmaceutical, biotechnology, and medical device companies. The software recognizes the local time settings used in the client PC, and presents the data in the local time zone by default. Can customers use virtual servers? Through pioneering and innovative engineering, the company has developed small, compact, superior monitoring and recording tools that provide unmatched accuracy and integrity for temperature and humidity monitoring and validation applications. Not to mention the delay in development when it comes to blood samples from clinical trials. Ralf Freese, Medical Director, Director Business & Corporate Development, CTC North Developing medicines, Bluetooth is likely here to stay. The user interface is intuitive, with embedded prompts and functional Tours to guide users through common tasks, provide onscreen instructions, and embedded tooltips. Can you explain VaiNet technology? Instead, lyophilization uses freezing conditions under vacuum. Its not hard to learn. This allows us to bring in virtually any measurement. For instance, a given Cold Room (CR-101) is equipped with a Vaisala Data Logger (S/N 1234). 202 0 obj In terms of alarming, viewLinc is relentless. We use Vaisalas MI70s to calibrate the RFL100 probes. I k':*"% This value is important because it ensures a perspective beyond price, or the immediate cost of acquisition. What is a typical setup for this.. For example we have some customers that only want to monitor their CO2 incubators. Because our clients are seeking FDA approval, the FDA needs to survey everything involved with the product that has been submitted for approval. Eg DL4000 with RFL100 for the same lab? We also use Vaisalas CAB100 in our clean suites to monitor ambient temperature, relative humidity, and differential pressure., VaiNet Wireless Temperature & Humidity Data Logger RFL100 for wireless monitoring of controlled areas. viewLinc provides an array of potential alarms to ensure that users are notified of system problems, including system errors, configuration issues, calibration expiration, and data that is out of specification. Does it take up 2 channels?. In all cases, these notifications are configurable for recipients and delays, as well as method of notification. Who is Vaisala, and what is the Vaisala presence in the CMS Market? How is mapping related to the viewLinc system? Second, viewLinc monitors the incoming data and the sensor array, generating alarms and notifications as needed to ensure the incoming data remains within specifications. But we need that kind of data integrity and access control for GMP.. You can easily pull a report on only the data you need., The viewLinc system has the best user experience of the monitoring systems Ive worked with. In support of commercially approved medical devices and drug products to over 30 countries across North America, South America, Europe, Africa, Middle East, and Asia, LSNEs services fall into three categories: development, manufacturing, and analytical. ?JK@m4@k;tx-to` To demonstrate this, you must determine what it is that your customer values! While LSNE provides multiple services, such as formulation processes for emulsions, suspensions, liposomes, and polymer or lipid nanoparticles (LNPs), the company is an industry leader in lyophilization (freeze drying), which stabilizes biologic substances through freezing and the sublimination of frozen water under high vacuum. Validation template documents are available for viewLinc installations, including the Full IQOQ (Installation Qualification and Operational Qualification) that regulators expect at system implementation. You can sell Vaisala as a business partner. Our clients also audit our Quality Systems, says Gabrault. The alarm reports are especially helpful. The viewLinc system gave us a single, centralized solution.. Currently he provides overall support for facilities, systems, utilities, and equipment. The design of viewLinc as a simple configurable system makes it easy to validate. Do we require a server for each site? Close to the cabinet end user can install a ViewLinc display to see all channel in one time ; Alternative is to connect PDT101 to DL4000 loggers via analog wiring without cabinet ; no display in that case for each measurement location., GMP Manufacturers (Pharmaceuticals and medical devices). Designed for use with vLog Software and Veriteq viewLinc (for on-going monitoring & alarming). Available now with RFL100 for incubator application.see 6. How would we perform signal strength testing? These proprietary sensors speak the same language, and communicate without any need for custom programming. 9. Vaisala invented the modern way of measuring relative humidity with a capacitive sensor, like the HUMICAP. Vaisala provides a care agreement which ensures timely upgrades as the system is improved, and ensures access to validation documents and support. Is there any particular way the server must be installed? @ qv6.A#qfx(t7 zqm5Bl4~IiU4uNFnmj_jn2y]i2y43D]bjeq/jG_(qL*uvxTiM Ziy BM$`+hY>[&o&E];bas]E]yukjhU'TU%Pe^i{ ~sP.-YZV:ok_!!iYx\Ccq~!mkD Using heat to remove moisture would degrade many products. From that point on, users can make their own reports and see only the data thats relevant to them. In addition the mapping data may be used to decide where to place monitoring sensors for the viewLinc system. A Monitoring System, in this context, collects temperature, humidity, and other environmental data for a manufacturing facility (or laboratory, pharmacy, museum, etc.). Multiple other parameters can be measured by the sensor array, such as differential pressure. 5. azc2XM#Cef@)`Q@Rrr dstu99KEn ! For legitimate changes to configuration data, all changes are tracked and recorded in a 21 CFR Part 11 compliant audit trail.