OHL Completes Validation of its Warehouse Management System for FDA Compliance
BRENTWOOD, Tenn., June 3, 2014 /PRNewswire/ -- OHL, a leading global 3PL provider, announced today that it has met all Food and Drug Administration (FDA) validation requirements for its primary warehouse management system (WMS) Synapse.
"The validation of our WMS shows we are committed to meeting the quality and regulatory requirements that come with healthcare," said Shawn MacCartey, OHL Senior Vice President, Healthcare. "The WMS validation confirms that procedures and controls are in place to ensure the authenticity, integrity, and when appropriate, the confidentiality of electronic records."
The validation includes development of documentation to demonstrate WMS's compliance with the requirements of FDA 21CFR Part 11 and applicable pharmaceutical and medical device regulations. The validation was supported by the Arbor Group, a world renowned leader in full scope software testing and validation services for life sciences companies.
"Synapse is OHL's premier WMS, configured to meet all of the requirements of our demanding warehouse logistics customers," said Eric Douglas, OHL Chief Information Officer. "We have some of the top healthcare companies in the world on our platform, as well as many of the nation's top retailers, e-commerce providers and manufacturers. We are proud to say the system passed all of the validation requirements."
OHL is one of the largest 3PLs in the world, providing integrated global supply chain management solutions, including transportation, warehousing, customs brokerage, freight forwarding, and import and export consulting services. OHL operates more than 130 value-added distribution centers, offers comprehensive transportation management services, employs nearly 7,000, and has offices worldwide. OHL has specific expertise in healthcare, with many medical device, pharmaceutical, home healthcare and hospital customers utilizing OHL's services for warehousing and transportation management. OHL is also skilled at direct-to-consumer fulfillment, serves a wide range of business sectors from specialty retail to manufacturing, and specializes in the healthcare, apparel, electronics, printing, food and beverage, and consumer packaged goods industries. www.ohl.com
About Arbour Group
As a global leader specializing in providing a full scope software testing and validation services, Arbour Group L.L.C. helps life sciences companies ensure that key business systems are functional and in full compliance with applicable FDA and international regulations and guidelines. Arbour Group's software validation expertise includes enterprise software applications, software as a service (SaaS) and virtualized infrastructure solutions such as VMware. In addition to focusing on software systems, their validation process addresses training and the effectiveness of operating procedures. Arbour Group also offers maintenance programs that provides a cost effective way to stay in compliance. www.arbourgroup.com