Intrinsic Imaging Implements ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Bolton, MA, San Antonio, TX, March 6, 2012
Intrinsic Imaging, LLC, announces today that in addition to its ISO 9001 certification, it has now implemented, and is consistent 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 of 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 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 system implementation 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 Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP 5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than seventy board-certified fellowship trained radiologists, robust and scalable clinical imaging technologies and its ISO certified quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world.