Hardware and web applications meet the requirements to support customers that store and transport pharmaceuticals throughout Europe
Rochelle Park, NJ, September 20, 2016 – ORBCOMM Inc. (Nasdaq: ORBC), a global provider of Machine-to-Machine (M2M) and Internet of Things (IoT) solutions, today announced that it has received the Good Automated Manufacturing Practice (GAMP® 5) official certification of approval from the European Institute for Pharma Logistics (EIPL) for its Euroscan-branded product line of temperature recording devices and cold chain monitoring systems. GAMP 5 guidelines are published by the International Society for Pharmaceutical Engineering (ISPE) and provide a flexible, risk-based approach on how to define and implement quality procedures, including compliant computerized systems, that support Good Distribution Practices (GDP) of pharmaceutical products for human use.
Following a thorough audit by EIPL as well as several pharma customers, ORBCOMM’s processes, procedures and documentation for select temperature recorders, modules and cold chain monitoring solutions have been approved to meet the GAMP 5 guidelines for the European market. This approval confirms that these ORBCOMM cold chain compliance products are a reliable and cost-efficient choice for customers that need to gain complete traceability of their operations, report storage conditions, including deviations in temperature settings, and protect the quality and integrity of their refrigerated assets throughout the European supply chain.
“ORBCOMM’s GAMP 5 approval is a significant milestone in demonstrating the high-performance, integrity and reliability of our products and ensuring that our pharmaceutical customers in Europe achieve complete cold chain compliance,” said Christian Allred, ORBCOMM’s Senior Vice President of Global Sales. “By utilizing our Euroscan-branded temperature recorders and web reporting applications, customers will improve their cold chain operations from end to end and gain total assurance of an uninterrupted cold chain from the product’s point of origin all the way to the end customer.”
ORBCOMM’s certificate of approval from EIPL is available upon request by contacting firstname.lastname@example.org.
For more information about ORBCOMM’s temperature recorders and cold chain solutions for the European market, please visit us at the 66TH IAA Commercial Vehicles trade show in Hall H27, Stand D23 from September 22-29, 2016, at the Fairgrounds of Deutsche Messe in Hannover, Germany.
About ORBCOMM Inc.
ORBCOMM Inc. (Nasdaq: ORBC) is a leading global provider of Machine-to-Machine (M2M) communication solutions and the only commercial satellite network dedicated to M2M. ORBCOMM’s unique combination of global satellite, cellular and dual-mode network connectivity, hardware, web reporting applications and software is the M2M industry’s most complete service offering. Our solutions are designed to remotely track, monitor, and control fixed and mobile assets in core vertical markets including transportation & distribution, heavy equipment, industrial fixed assets, oil & gas, maritime, mining and government.
With nearly 20 years of innovation and expertise in M2M, ORBCOMM has more than 1.5 million subscribers with a diverse customer base including premier OEMs such as Caterpillar Inc., Doosan Infracore America, Hitachi Construction Machinery Co., Ltd., John Deere, Komatsu Ltd., and Volvo Construction Equipment, as well as end-to-end solutions customers such as C&S Wholesale, Canadian National Railways, CR England, Hub Group, KLLM Transport Services, Marten Transport, Swift Transportation, Target, Tropicana, Tyson Foods, Walmart and Werner Enterprises. For more information, visit www.orbcomm.com.
Certain statements discussed in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally relate to our plans, objectives and expectations for future events and include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Such forward-looking statements, including those concerning the Company’s expectations, are subject to known and unknown risks and uncertainties, which could cause actual results to differ materially from the results, projected, expected or implied by the forward-looking statements, some of which are beyond the Company’s control, that may cause the Company’s actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. In addition, specific consideration should be given to various factors described in Part I, Item 1A. “Risk Factors” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2015, and other documents, on file with the Securities and Exchange Commission. The Company undertakes no obligation to publicly revise any forward-looking statements or cautionary factors, except as required by law.
Michelle Ferris, Director of Corporate Communications.
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