Vaisala Life Science Services Integrated Service for Maximum Compliance, Safety and Performance LIFE SCIENCE SOLUTIONS FOR REAL LIFE

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1 Vaisala Life Science Services Integrated Service for Maximum Compliance, Safety and Performance LIFE SCIENCE SOLUTIONS FOR REAL LIFE

2 Get Your Controlled Environment Under Control Simplified Compliance That is the dream. But every company with operations depending on controlled environments knows the challenges of finding a streamlined technology solution. One that offers reliable performance and full compliance while reducing the risk of damaged, lost or adulterated products. The Vaisala solution does it with low cost of ownership and minimal management. More Vendors, More Complexity, More Risks The trouble is that most controlled environments themselves are not under

3 control, being patchworks of systems from multiple vendors. And that is where the risks lurk in the gaps and discontinuities of different systems. The more vendors, technologies, applications, protocols, interfaces, service schemes and people there are the more likely something will go wrong. Creating real trouble, costs and stress. However, there is a way. Integrated Solutions Vaisala specializes in highly accurate and reliable measurement technologies that work together seamlessly. Our technologies, systems, operations and services share the same Vaisala DNA that ensures advanced accuracy, performance and reliability. For the Life Science industry including pharmaceutical, medical devices, biotechnology and other supply chain participants we offer measurement instruments, monitoring systems, cold chain monitoring, validation and related services. Verified Leader in Measurement Technology Our technologies are quality leaders in measuring relative humidity, temperature, dewpoint, differential, pressure, and carbon dioxide, with highly reliable monitoring systems, measurement instruments and data loggers. Vaisala Serves Most of the Top 50 Pharmaceutical Companies We are a strategic partner for safety, compliance and profitability serving more than 3,200 life science customers big and small in 57 countries. Our over 800 installed systems include GxP regulated warehouses, laboratories, cleanrooms, incubators, refrigerators, freezers, and transportation.

4 Widest Range of Integrated Services Vaisala Life Science Services Installation Validation Mapping Calibration & Repairs Technical Support Support Plan Training 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 within two years was met. Joe Cwiertniewicz, McKesson Facilities Manager Vaisala offers a single reliable source for a broad range of leading technologies, solutions and services for controlled environments. Our mission is to help you mitigate operational risks and enable your systems to fulfill their maximum lifespan and return on investment. Hands-On Support Partner Vaisala service and support teams provide you with an in-depth understanding of critical Life Science environments, network technologies and metrological devices. They ensure that your systems are efficient and meet or exceed the most stringent compliance requirements. We help you achieve business goals as well through improved efficiency, risk reduction and cost savings. So you can focus on your core activities.

5 Installation Installation Service Take advantage of Vaisala s expertise. Dedicated technicians are available to manage the end-to-end installation of your Continuous Monitoring System (CMS) to ensure a flawless system launch and deployment with full system functionality and user training. Continuous monitoring Customized Configuration Vaisala-executed CMS installations are comprised of the setup and deployment of all sensing equipment and network devices, installation of drivers and software, configuration of the system to suit your specific needs, and user training. 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 allocation requirements Ultra-Low Temp Freezers Refrigerators Incubators Remote Alarming

6 Validation Compliance to Global GxP Standards Ensure a high quality validation and reduce execution time by utilizing Vaisala s professional services. With hundreds of successful validations under our belt, Vaisala s expertise and deep understanding of regulation in the Life Science industry can be an asset to your quality system. We offer on-site Installation Qualification and Operational Qualification services to help you meet your regulatory obligations. The IQ captures the baseline configuration of your system, to assist you in providing evidence of control, following GxP guidelines. The OQ provides evidence that your CMS operates 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 Validation Service for Fast Deployment With proven processes for validating new system installations, upgrades and expansions, we can get you up and running quickly, without sacrificing quality. Vaisala validation technicians have in-depth knowledge of Vaisala s sensing devices and the CMS software. This expertise allows us to complete a typical validation in less time, which in turn allows your staff to stay focused on core operations. Key Benefits: Saves days of work by the customer, no personnel allocation required Presentation-Quality Report Documents Cost efficient and fast service from execution to audit-ready documentation Information and advice provided during visits Increasing in-house knowledge and competence

7 Mapping Temperature & Humidity Mapping Understanding the dynamics of a space is crucial to the safe utilization of that space for the manufacture, storage, processing and distribution of sensitive products such as pharmaceuticals and biologicals. This is a required step in demonstrating appropriate control over environmental conditions to ensure product safety. This mapping service is currently available only 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 compliance study documents Applications: Refrigerators/Freezers/Cold rooms Incubators Stability Chambers Warehouses/Storage areas/distribution Centers 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

8 Calibration & Repairs Regular calibration is a regulatory requirement to ensure the ongoing accuracy of measurements and ultimately to safeguard products and consumers. However, it poses a logistical challenge to organizations: how to ensure compliance without costly downtime. Vaisala offers a suite of services to ensure regulatory compliance without incurring additional risk. From service center calibrations, to loaner devices to ensure continuity of monitoring during the calibration process, to in situ on-site calibrations, Vaisala has you covered. Service Center Calibration & Repair Vaisala service centers offer the highest level of calibration accuracy and the widest range of services which encompass accreditation, traceability, repairs and upgrades traceable to the SI through your region s recognized national or international standards (commonly referred to as NIST traceability). Vaisala is certified to ISO9001. In addition to this the Vaisala offering includes calibrations accredited to IEC/ISO17025:2005, ANSI/NCSL Z540-1, ANSI/NCSL Z540.3 and complaint to ISO10012 available at select locations. Calibration and repair services are globally available from Vaisala s Regional Service Centers. Standard calibration options are available for all monitoring system sensor equipment. If required, Vaisala can work to create a calibration option to meet specific requirements or test points. If repairs are required on any device, these can be performed with the calibration, eliminating the time and aggravation of working with multiple vendors. Rental data loggers are also available to enable continuous monitoring during device calibrations. Key Benefits: Deep product expertise Highest accuracy (lowest uncertainty) offering Fast diagnostic and spare part access Software upgrades / firmware updates Repairs made at the time of calibration 3rd party audited and accredited labs Customer selectable test points and calibration options to meet specific customer requirements Competitively priced Spares are available for selected products supporting gapless data records Accredited Calibration Options Boston, USA Helsinki, Finland Beijing, China Tokyo, Japan STANDARD CALIBRATION SERVICES Relative Humidity Relative Humidity Relative Humidity Relative Humidity Temperature Temperature Temperature Dew Point Dew Point Dew Point Dew Point Barometric Pressure Barometric Pressure Barometric Pressure Barometric Pressure Carbon Dioxide Carbon Dioxide Carbon Dioxide Carbon Dioxide ACCREDITED CALIBRATION SERVICES Relative Humidity Relative Humidity Relative Humidity Temperature Temperature Dew Point Dew Point Barometric Pressure Barometric Pressure Please for Calibration Services availability in your area check

9 On-Site Calibration On-Site calibrations combine compliance with convenience. In order to minimize the impact of regular calibrations on critical processes and staff, Vaisala calibration technicians can perform a wide variety of calibrations on-site to meet your specific needs often in situ, allowing monitoring to continue uninterrupted. Additionally, if replacement devices have been rented, our technicians can manage the full process of swapping these devices in prior to calibration and out following the calibration, as well as all required system updates to ensure gap-free data. Key Benefits: Minimal downtime for your sensors Device functionality test Gapless data records and accurate measurements Full As-Found / As-Left calibration certificates Wide selection of calibrations Staff can focus on core operations Prepaid Calibration Plans Vaisala instruments have the option of a prepaid calibration plan. Pre-paid plans protect against unanticipated increases in calibration costs over the period of the plan. With calibration interval notifications and calibration certificates that include As-Found and As-Left data, pre-paid calibration plans significantly reduce the cost of hardware maintenance over time. This service is not available in Japan. Key Benefits: Discounted calibration with protection from price increases (1-5 years) Low cost of ownership No annual purchasing orders to generate for planned maintenance costs Extended Warranties An extended warranty (max 5 years) ensures hardware repairs/replacements, guarantees system performance and eliminates quotation/approval procedure delays. This service is not available in Japan. 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 Technical Support The Vaisala front-line support team members are famously tenacious problem solvers with deep product knowledge. They handle all technical inquiries related to the CMS and Validation systems. Support request response time is within 2 hours, typically resolving problems the first call. The teams are located in the Americas, Europe and Asia-Pacific. The CMS includes standard support after original purchase: Online, phone or support during device and software installation Vaisala s online HelpDesk is the first point of contact for all technical support: Support Plan This premium support plan maximizes your CMS system s availability, lifespan, value and performance. Service includes: extensive installation and validation support prioritized 24 hour access to technical support every day of the year (not available in Japan) web-based training by our technical staff self-teaching tools annual system review and reconfiguration software upgrades

11 Training Onsite Training On-site CMS personnel training can be separate or combined with installation. The courses combine direct instruction with participatory exercises and Q&A sessions to provide full system understanding with operational competence. tools are also available to support plan holders and enable your users to educate themselves on their own schedules. Web-based Training Web-based instructor-led training offers a simple way to train decentralized groups and is available as a component of a Support Plan or on a pay-as-you-go basis. Interactive multimedia training

12 Please contact us at Use mobile phone to read the code. Ref. B211313EN-C Vaisala 2015 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.