Laboratory solution for Cellular Therapy at Oslo University Hospital Trust (OUS)

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The system would be developed for healthcare / hospital cell / gene / therapy laboratories. It will be required that the candidate has knowledge of the EU / US Good Manufacturing Practice (GMP), the EU Cell Directive and ISBT 128 . The software for CT also has to comply with the regulation FOR-2008-03-07 Nr. 222 . The technical requirements for keeping track of information and receiving alerts accordingly.Laboratory software for CT would include (the list is not exhaustive):*Cellular Therapy at the Radium Hospital (CT)— The system needs to provide process support in the production of Dendritic Cell vaccines, harvesting, processing, storage and distribution of therapeutic cells used as Stem cell Support for High Dose Treatment (autologous and allogeneic hematopoietic progenitor cells from bone marrow and peripheral cells), reception, storage, distribution and tracing of umbilical cord blood units for use in stem cell transplantation.*Cellular Therapy (ExVivo)— The system needs to provide process support for the production of cells for cell-therapy.The Hospital Trust departments that use these solutions will provide national services and have accreditation after both international and national standards.The Laboratory software for CT and ExVivo must satisfy requirement set by GAMP in a way that we will be able to validate in order to document to supervisory authorities that GAMP is fulfilled.The procurement of the system solution includes such as:*System software*Consultant services in conjunction with— Deployment of the solution— Installation(s)— Integration(s)— Connections of modalities— Customization (Adjustment and Adaptations to systems and functions)— Configuration— Data migration— Test— Training of users— Documentation*Other consultancy services*Support and maintenance of the software and system solutionIt will in the tender documents be complementary described whether or not some of the items in the enumeration above will be added as options.The Laboratory software for CT should preferably be a fully developed system on the market as 'Off the shelf'.There is uncertainty about the amount and scope.1 500 0005 000 000