Tender: Tissue and Cell Management System for Stem Cell Transplantation and Cellular Therapy – King's College Hospital

About

King's College Hospital NHS Foundation Trust is seeking a supplier for a tissue and cell management system to support its stem cell transplantation and cellular therapy laboratory services. The Trust is carrying out preliminary market engagement under the Procurement Act 2023 to identify providers and interest because its current commercial off-the-shelf system (in live use since 2023) runs on infrastructure reaching end of support in January 2027 and the Trust is assessing upgrade, migration or replacement options to ensure continuity from 2027. The required solution must provide end-to-end management and traceability from donor and patient registration through collection, processing, cryopreservation, storage, issue and administration, including ICCBBA ISBT 128 labelling, a complete and secure audit trail, quality management (including deviations and non-conformances), inventory and storage location management, and reporting; it must enable HTA licensing and FACT-JACIE accreditation and meet electronic record and traceability requirements under GAMP 5, GMP Annex 11 (Computerised Systems), 21 CFR Part 11 and MHRA data integrity expectations. Supplier support for installation, operational and performance qualification (IQ/OQ/PQ) before go-live and an approach to upgrades that controls system changes and minimises the revalidation burden are required. The Trust is particularly interested in which suppliers can meet these requirements and any gaps, deployment models (on-premise, supplier-hosted or cloud/SaaS) including Microsoft-based infrastructure (Windows Server and Microsoft SQL Server) or fully hosted services, live interfaces with Epic or other UK electronic patient records, typical implementation timescales including validation and data migration, indicative costs for the Outline Business Case, availability through NHS England-approved frameworks or dynamic markets, and suppliers' willingness to take part in a competitive procurement and views on the Trust's proposed approach and timescales.