Customizing an adaptive case management software in a GMP production lab as a quality management system for clinical trial PET radiopharmaceuticals development and production

1 EU Legislation Eudralex Volume 4, Good Manufacturing Practice (GMP) 2 BenchSys, Labage SA http://www.benchsys.com/ 3 EU Legislation Eudralex Volume 4, chapter 4, documentation, 01/2011 http://ec.europa.eu/health/files/eudralex/vol-4/chapter4_01-2011_en.pdf 4 Dynamic case management – An old idea catches new fire, December 28, 2009 Based on the integration of our own core know-out and the expertise (software, hardware) of a specialized small and medium enterprise, we implemented a new cost effective quality system for GMP radiopharmaceuticals production in an academic environment. Our decision to use an affordable adaptive case management software instead of a suite of a laboratory information management software (LIMS), an electronic laboratory notebook (ELN), and a documentation management software (DMS) greatly simplifies and speeds the implementation of a traceability and quality management system in GMP facilities. Case Management is a structured, collaborative, dynamic and information-intensive process driven by outside events that requires incremental and progressive responses from the business domain handling the case. An batch records a good example of case folder (fig. 1).