Manufacturing Execution System (MES) software for CGCT pre-GMP Advanced Therapies Digital & Automation Productivity Testbed

Tender description

Provision of a Manufacturing Execution System (MES) tailored explicitly for the field of cell therapies, The MES platform should enable resource scheduling, inventory optimisation, management & execution of electronic batch records and overall manufacturing workflows, review and release activities. All workflows should be client-configurable and controlled, through the use of a zero-code, platform-embedded, builder configuration tool. The platform should be designed to comply with US FDA, EU EMA & UK MHRA guidance and aligns with the GAMP5 validation methodology, as well as being CFR 21 Part 11 compliant. Lot 1: Provision of a Manufacturing Execution System (MES) tailored explicitly for the field of cell therapies, The MES platform should enable resource scheduling, inventory optimisation, management & execution of electronic batch records and overall manufacturing workflows, review and release activities. All workflows should be client-configurable and controlled, through the use of a zero-code, platform-embedded, builder configuration tool. The platform should be designed to comply with US FDA, EU EMA & UK MHRA guidance and aligns with the GAMP5 validation methodology, as well as being CFR 21 Part 11 compliant.