GE Healthcare Launches Facility Validation Services

GE Healthcare has launched GE Healthcare Facility Validation Services, a new global service that will provide customers with comprehensive international regulatory compliance for facilities and manufacturing systems compared with complex traditional approaches. The service applies to new and existing facilities.

The Facility Validation Services will use a Modular Validation Platform to work with customers as they plan and design their facilities and manufacturing processes to the required regulatory standards. GE Healthcare Facility Validation Services will employ the company’s project and business management expertise, as well as operational methodologies such as Lean and Six Sigma, aimed at providing an integrated global service.

Victor Bornsztejn, global growth director, GE Healthcare, said, “We aim to help eliminate the current disconnection between drug/process development and facility validation. GE Healthcare has played a pivotal role in biopharmaceutical drug and process development for decades, so we believe we are uniquely positioned to drive this change in the industry.

“The launch of GE Healthcare Facility Validation Services is a major milestone for GE Healthcare, combining many of the Company’s capabilities,” Mr. Bornsztejn added. “Drug manufacturers are regularly receiving citations and warnings that are linked to their validation, usually for reasons that are easily avoidable. We believe our range of solutions and expertise enables us to offer a very broad range of complete product/lifecycle services at a time when compliance and cost-containment are key industry concerns.”

No comments: