Software Solution for Electronic Quality Management System (eQMS)

Descriptions

The Vaccine 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 SMEs, which are rich in new vaccine technologies, where VMIC provides expertise in process development and 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, which is a value driver in terms of attracting funding for further development, partnering with the pharmaceutical industry for development to launch and contract manufacturing. 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 programme to manufacture the Oxford COVID-19 vaccine. VMIC UK is seeking an eQMS IT system, for its Quality Assurance function, which meets the requirements as set out in the tender documents. This system is within scope for regulatory compliance as it forms part of the VMIC GMP manufacturing capability. As part of the supply of this system, suppliers will be expected to support VMIC's validation of the system. The delivery of the system must also include other elements as set out in the tender documents. The contract term required is 3 years with an option to extend for a further 2 x 12 month periods. VMIC considers that this contract may be suitable for economic operators that are small or medium enterprises (SMEs). However, any selection of tenderers will be based solely on the criteria set out for the procurement. To participate in this procurement candidates must send an expression of interest to Tenders@vmicuk.com . Procurement documents are available at https://www.vmicuk.com/tenders . All correspondence and expressions of interest relating to this procurement must be made through this address. VMIC expressly reserves the right: (i) not to award any or the whole contract as a result of the procurement process related to the publication of this notice; and (ii) to make whatever changes it may see fit to the content and structure of the procurement; (iii) to procure some or all of their needs and requirements covered by this notice outside of this procurement exercise and resulting agreement. In no circumstances will VMIC be liable for any costs or losses incurred by the candidates. Any expenditure, work or effort undertaken prior to contract award is accordingly a matter solely for the commercial judgement of the candidate.