Vaisala viewlinc Monitoring System Services

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1 Vaisala viewlinc Monitoring System Services Integrated Service for Maximum Compliance, Safety and Performance

2 Vaisala viewlinc Life Cycle Maintenance Agreement Software Maintenance Technical Support Training Calibration Vaisala s Life Cycle Maintenance Agreement (LCMA) supports a risk-based approach to monitoring regulated environments, as suggested in regulatory guidance. The agreement comprises a modular set of services that help ensure your operations comply with regulations. The Vaisala viewlinc Life Cycle Maintenance Agreement is designed to ensure that your investment in the viewlinc Monitoring System is protected for years to come. We offer a range of services including: software maintenance, priority technical support, training, calibration and extended warranty to help you get the most out of your continuous monitoring system. Several regulations in life science and other industries address the maintenance and risk management of monitoring systems. For example, data integrity requirements of the FDA s Title 21 CFR Part 11 and the EU s GMP Annex 11 have outlined the need for ongoing maintenance and support over the entire life cycle of a system. Software Maintenance Monitoring system software doesn t operate in isolation. It lives within a changing ecosystem of computerized and automated systems, network technology, and regulations. Environmental monitoring systems must be adaptable if they are to continue to provide value to your operations over time. Our team of expert software developers, electronics engineers, technical support specialists, and regulatory experts will maintain your monitoring system s compatibility within this changing ecosystem. We are continually improving the viewlinc monitoring system, allowing users to maintain a high level of quality in critical products and processes. Software Maintenance provides: Software service updates to improve performance and address new compatibility issues New versions of the software providing you with additional functionality and increased usability Updates to Validation & Good Automated Manufacturing Practice documentation

3 Priority Technical Support Whether you ve had unplanned downtime in your facility, or need help configuring the system to meet your needs, our skilled technical support specialists are standing by to assist. Technical Support provides: 24/7 access to technical support for critical, system-down situations Priority access to technical experts The Vaisala technical support team members are famously tenacious problem solvers with deep product knowledge. Our responsive Helpdesk service is a one-stop channel for all your technical questions. For operationally critical systems, Vaisala offers premium support as part of the Life Cycle Maintenance Agreement. This optional support agreement helps to ensure system availability and continued value to your operation. Benefits: Availability: Whenever you need it, globally Expertise: Trained technical experts at your service Fast Response: Talk directly to skilled technicians with application knowledge Knowledge: Let our team make your team expert system users Relationship: With premium support, the Vaisala team is able to build knowledge on your particular operations and processes Comprehensive Training We help you get the most out of your monitoring system by educating viewlinc users on the system s functions and capabilities. Easy to access training increases software adoption and engagement, so whether you are deploying a new monitoring system, expanding an existing one, or adapting to staff changes, training is critical to your success with the system. Training includes: Web-based live training sessions with technical support experts, twice annually On-demand access to task-focused elearning videos Comprehensive user guides and quick start guides

4 Calibration Regular calibration ensures the ongoing accuracy of measurements, safeguarding products and consumers. However, calibration can pose a logistical challenge to organizations: how to avoid costly downtime? Vaisala offers a suite of services to help ensure the regulatory compliance of your operations. Key Benefits: Service Center Calibration Onsite Calibration Probe Replacement Accuracy always ensured in full measurement range Minimal downtime for your measurement Factory calibration accuracy with minimum downtime, also available as accredited (ISO/IEC ANSI/NCSL Z540-1) Optional accredited calibrations available (ISO/IEC 17025, ANSI/ NCSL Z540-1) Vaisala system specialist available at your site Easy calibrations with minimal effort Adjusted for best accuracy Single point or multipoint calibrations available Full measurement range accuracy ensured High accuracy, low uncertainty calibrations Staff can focus on core operations You receive calibration certificates with As-left values for the replacement probe and As-found values for the original probe Functional testing included Device functionality verification Vaisala field technicians can perform probe replacement as a service Software upgrades / firmware updates Gapless data records and accurate measurements Measurement interruption less than one minute ACCREDITED CALIBRATION SERVICES Boston, USA Helsinki, Finland Beijing, China Tokyo, Japan Relative Humidity Relative Humidity Relative Humidity Relative Humidity Temperature Temperature Temperature Dew Point Carbon Dioxide Dew Point Barometric Pressure Barometric Pressure Barometric Pressure Dew Point Please check store.vaisala.com for Calibration Services availability in your area.

5 Standalone Services viewlinc System Services Installation Validation Mapping Training Calibration The Vaisala team is well qualified, easy to work with, and became a part of our team. This relationship was a major reason that our original goal of project completion [for a 2000 point, 60 site system] within two years was met. Joe Cwiertniewicz, McKesson Facilities Manager Standalone Services Several services you may not need on an ongoing basis are available for purchase. Using Vaisala s professional services will reduce the costs involved in system installation and validation, while ensuring high quality. Your personnel can stay focused on day-today operations with Vaisala technicians working in the background. A Hands-On Support Partner Vaisala service and support teams provide you with an in-depth understanding of critical environments, network technologies and measurement devices. We help ensure that your systems are efficiently and effectively deployed to meet or exceed the most stringent compliance requirements.

6 Installation Installation Service Take advantage of Vaisala s expertise. Dedicated technicians are available to manage the installation of your Vaisala monitoring system to ensure a flawless system deployment with full system functionality and comprehensive user training. Continuous monitoring Customized Configuration Vaisala-executed installations include the setup and deployment of all sensing equipment and communications devices and installation of drivers and software and configuration of the system to suit your specific needs. Existing Network viewlinc Monitoring & Alarming Remote Monitoring Key Benefits: Operational integration, help and training Smooth start-up, lower costs, higher productivity Focus on core business with minimal staff requirements allocated to installation work Ultra-Low Temp Freezers Refrigerators Incubators Remote Alarming

7 Validation System Validation for GxP Compliance Ensure a high quality validation and reduce system implementation time by using Vaisala s expertise and deep understanding of GxP quality systems. We offer on-site Installation Qualification and Operational Qualification services. The IQ captures the baseline configuration of your system and provides evidence of control that aligns with GxP guidelines. The OQ provides evidence that your monitoring system is operating as designed, encompassing all GxP functions of the system, including audit trails, tamper-proof data, and the relevant requirements of 21 CFR Part 11, Annex 11 and PFSB Key Benefits: Saves days of work with no personnel allocation required Presentation-quality report documents Quickest way to get from system implementation to audit-ready operations Information and advice provided during visits helps end users quickly gain system expertise Vaisala Validation services were an economical choice, saving us a lot of time. We learned a lot with the Vaisala technician who was there to provide advice and answer our questions... Senior Director of Facilities, US-based clinical-stage biotechnology company URS FS TM RA

8 Mapping Service Temperature and Humidity Mapping Understanding the dynamics of a space is crucial to the safe use of that space for manufacturing, storing, processing and distributing sensitive pharmaceuticals and biologicals. Mapping studies demonstrate an understanding of the variability of conditions within a controlled environment. Vaisala s mapping service is currently available in Europe, China and Japan. Service includes: Area, room and chamber thermal mapping and analysis Challenge tests on empty/loaded chambers and static/dynamic storage areas Quality ensured by Vaisala data loggers and validation system Presentation-quality mapping study documents Applications: Refrigerators/Freezers/Cold rooms Incubators Stability Chambers Warehouses/Storage areas/ Distribution Centers Training Onsite Training On-site personnel training can be purchased separately or combined with a viewlinc system installation. Training includes direct instruction with participatory exercises and Q&A sessions to ensure users fully understand how to use viewlinc. Web-based Training Web-based training offers a simple way to train decentralized groups and is available on a pay-as-you-go basis. Interactive multimedia training tools are also available to Life Cycle Maintenance Agreement customers and enable your users to educate themselves on their own schedules.

9 Calibration Service Vaisala service centers offer the highest level of calibration accuracy and the widest range of services. All service center calibrations are traceable to the international system of units (SI). Vaisala Corporation is certified to ISO9001 and ISO In addition, Vaisala service center calibrations are accredited to IEC/ ISO 17025:2005, ANSI/NCSL Z With Vaisala as your calibration vendor, if an out-of-specification is detected, we can fully restore device functionality during calibration. We also offer loaner data loggers to enable continuous monitoring when you send your devices for service center calibrations. On-Site Calibration On-site calibrations combine compliance with convenience. Vaisala technicians can perform a wide variety of calibrations on-site. In many cases, on-site calibration allows monitoring to continue uninterrupted. Optionally, you can have a Vaisala calibration technician swap loaned data loggers prior to and following calibrations. Having a Vaisala specialist at your site also provides the opportunity for ad hoc training on the viewlinc system. Probe Replacement Service Probe replacement service ensures factory calibration accuracy with minimum downtime. Service includes delivery of traceable or accredited calibrated replacement probes, allowing replacement of your data logger s measurement element in minutes as well as an as-found calibration of your original sensor. Prepaid Calibration Plans Having a prepaid calibration plan protects against unanticipated increases in calibration costs over the period of the plan. The plan includes priority handling in service centers, free shipping, and scheduled calibration reminders. Vaisala services were an economical choice, saving us many days of work. We also learned a lot more about the system with the Vaisala technician answering questions and providing advice on how to make the system easy to use. Paul Lundy Senior Director of Facilities Seattle Genetics

10 Please contact us at Use mobile phone to read the code. Ref. B211313EN-D Vaisala 2018 This material is subject to copyright protection, with all copyrights retained by Vaisala and its individual partners. All rights reserved. Any logos and/or product names are trademarks of Vaisala or its individual partners. The reproduction, transfer, distribution or storage of information contained in this brochure in any form without the prior written consent of Vaisala is strictly prohibited. All specifications technical included are subject to change without notice.