Enterprise Resource Planning (ERP) solution

Description

Enterprise Resource Planning (ERP) System potentially including Manufacturing, Materials Movement, Warehousing, Order Management, Quality Management, Engineering, Asset Management, Finance and Human Resources sub-systems. The system will be required to operate in a regulated pharmaceutical environment and must conform to GxP compliance requirements including EudraLex Volume 4, EudraLex Volume 4 Annex 11, and US FDA 21 CFR parts 11, 210 and 211. The solution is required to be a cloud-based 'Software as a Service' solution, to include Consultation, Project Management, Implementation, Hosting, Service Support and upgrades and must include robust Disaster Recovery Planning and Business Continuity provisions. The system and all data must be hosted in the UK. Please note that this procurement opportunity has been cancelled. The procedure has been discontinued at SQ stage due to changes in business requirements and priorities. VMIC is in the process of considering its future requirements and will take any decision on any future procurement once this process has completed. Lot 1: The Vaccines Manufacturing and Innovation Centre (VMIC) is being established to promote, develop and accelerate the growth of the UK vaccine industry. This will be achieved through collaboration with the academic sector and subject matter experts which are rich in new vaccine technologies. VMIC provides expertise in process development and will provide manufacturing in the form of expert staff and a state-of-the-art manufacturing facility. VMIC will bridge the gap between research and expertise in development and manufacturing so that new vaccine products can enter clinical development. This is a value driver in terms of attracting funding for further development and partnering with the pharmaceutical industry for development to launch and manufacture vaccines. VMIC will also enhance UK preparedness and response capabilities for producing vaccines against emerging infectious diseases by allowing the UK government to use the facility and staff during an outbreak identified as a public health emergency of international concern. VMIC is a partner in the project to manufacture the Oxford Covid-19 vaccine. The programme has now reached the phase in which an ERP System needs to be procured and its deployment built into the plan. The compliance environment within which the organisation operates is governed by the following regulations which impose rigorous requirements on the organisation: 1) Eudralex Volume 4: Good Manufacturing Practice 2) Eudralex Volume 4 Good Manufacturing Practice: Annex 11 Computerised Systems 3) US FDA 21 CFR Part 11: Electronic Records & Electronic Signatures 4) US FDA 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 5) US FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals Given the prevailing circumstances VMIC must make every effort to bring online its manufacturing and support services at the earliest opportunity. To meet this goal the implementation of an ERP system is considered an urgent requirement. VMIC recognises that the service provider will be required to speedily provide robust solutions to its specific industry needs and anticipates a fully-managed configured off-the-shelf solution delivered with extensive support services based on industry knowledge and expertise, best in class project management and a low risk rapid implementation. The expectation of VMIC is that that the solution can be implemented using a staged modular approach. Initial licensing estimates will be based on 30 concurrent and 60 named user licenses. The form of contract will be based on the UK Government Mid-Tier model. The anticipated Term will be three years with an option to extend twice by 2 years on each occasion. Please note that this procurement opportunity has been cancelled. The procedure has been discontinued at SQ stage due to changes in business requirements and priorities. VMIC is in the process of considering its future requirements and will take any decision on any future procurement once this process has completed.