“Intrinsic Imaging's GAMP 5 implementation is a testament of our ongoing commitment to providing quality imaging core lab services." Said Todd Joron, BSc. MBA, President COO
(PRWEB) March 06, 2012
Intrinsic Imaging, LLC, announces today that in addition to its ISO 9001:2008 certification, it has now implemented, and complies with, the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice GAMP® 5 : A Risk-Based Approach to Compliant GxP Computerized Systems.
Developed by some of the world's largest international pharmaceutical and biotechnology companies from the Americas, Europe and Japan, the ISPE GAMP® 5 is a pragmatic and practical industry guide to achieve regulatory compliant GxP computerized systems in an efficient and effective manner.
Contributing regulatory authorities of GAMP 5 include the United States Food and Drug Administration (FDA), United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), Health Products Safety Agency of France (AFSSaPS) and Regierungspräsidium Darmstadt of Germany.
In providing clinical image management and radiological review services for Phase I-IV clinical trials, Intrinsic Imaging designs, develops or implements advanced computerized imaging management systems. Intrinsic Imaging’s implementation and compliance with GAMP 5 demonstrates that it currently maintains an effective, scalable and robust framework that safeguards patient safety, product quality, and data integrity and ensures all computerized systems are fit for intended use and compliant with applicable local and international regulations.
Intrinsic Imaging’s GAMP 5 compliant systems development life cycle has been implemented across the entire organization and is applicable to all therapeutic areas including, but not limited to, Cardiovascular, Central Nervous System, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal and Oncology.
“Intrinsic Imaging's ISO 9001:2008 quality management system certification and GAMP 5 systems compliance are testaments of our ongoing commitment to providing quality imaging core lab services to pharmaceutical, biotechnology, medical device and clinical research organizations around the world,” said Todd A. Joron, BSc, MBA, President & COO at Intrinsic Imaging.
About Intrinsic Imaging LLC
Located in Boston, Massachusetts, Dallas, Texas and San Antonio, Texas, Intrinsic Imaging is an ISO 9001:2008 certified and GAMP 5 compliant medical imaging core lab providing clinical image management and radiological review services in support of pharmaceutical, biotechnology, medical device and clinical research organizations that are conducting clinical trials. With its team of more than sixty board-certified diagnostic radiologists, its robust and scalable clinical imaging technologies and its ISO certified and registered quality management system, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world. For more information, please visit http://www.IntrinsicCRO.com.
Intrinsic Imaging LLC