Pharmaceutical traceability integreted with the patient file. Development of a traceability software package

The Clinical Pharmacy Department (CPD) of the Gustave Roussy Institute, has developed a traceability software package that is integrated with the pati ent file. The Traceability & Medical Devices Functional Unit manages the Bl ood Derivative Medicinal Product traceability circuits, the circuits of ove r 400 Sterile Medical Devices and, generally speaking, those for all pharma ceutical goods for which traceability is imperative. The SIMBAD-TRACE((R)) software package has been developed in situ and was first open for access i n March 1999. It enables pharmaceutical traceability data to be accessed fr om 500 networked workstations. The references tracked generated about 10,00 0 movements per year. In terms of performance, the system achieves three co mplementary objectives: 1) reporting traceability scores which reflect the ability of CPD and the establishment to pertinently respond to a complex re gulatory requirement on a daily basis; 2) the contribution of the tool to c ost containment with respect to allocating rare goods; the contribution of the software package to the implementation of medical device vigilance inqu iries, particularly descending inquiries. Finally, SIMBAD-TRACE((R)) is one of the pillars of our Quality Assurance Program (QAP). (C) 2001 Editions s cientifiques et medicales Elsevier SAS.