Electronic Pharmaceutical Quality Management System - Software Licence and Support

NHS Wales Shared Services Partnership Pharmacy Technical Services manufacture and prepare medicines for patient care under strict regulatory oversight by the Medicines and Healthcare products Regulatory Agency (MHRA). The organisation operates according to Good Manufacturing Practice (GMP) standards and is implementing an Electronic Pharmaceutical Quality System (ePQS) called Bizzmine to manage quality assurance, validation, and data integrity across its facilities, including the new Radiopharmacy aseptic unit. The ePQS has been configured and validated to meet EU GMP Annex 1 and Annex 11 requirements, ensuring compliance with regulations governing electronic records, audit trails, and data safeguards. This procurement seeks to secure continued software licences and technical support from the incumbent supplier to maintain the operational and compliant state of the existing system. Switching to an alternative supplier would require complete system redesign and revalidation, creating significant regulatory risk and delays to critical services. The incumbent supplier is the sole provider capable of delivering the necessary licences and ongoing support required to maintain this validated system in compliance with MHRA requirements. This direct award is being pursued under Schedule 5 paragraph 7 of the Procurement Act 2023, as a change in supplier would result in incompatible systems and create disproportionate technical difficulties in operation and maintenance.