Software Solution for Electronic Quality Management System (eQMS)

The Vaccine Manufacturing and Innovation Centre (VMIC) requires an eQMS IT system, for its quality assurance function. The contract term is 3 years with an option to extend for a further 2 x 12-month periods.

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 has procured 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, the supplier is expected to support VMIC’s validation of the system. The delivery of the system also includes 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.

Candidates were assessed in accordance with the Public Contracts Regulations 2015 (as amended), on the basis of information provided in response to the procurement documents. The procurement documents can be accessed at: https://www.vmicuk.com/tenders

VMIC need to respond to the Covid-19 consequences immediately because of public health risks.

VMIC are reacting to a current situation that is a genuine emergency, to manufacture 70 million doses of a vaccine to cover the pandemic in as early as possible 2021. To meet this production target, the programme to achieve operation of the VMIC facility has been accelerated and therefore the procurement of the eQMS solution needs to be accelerated rapidly.

The Covid-19 situation is so novel that the consequences are not something VMIC should have predicted, and has changed the timescales of the project significantly.

Software Solution for Electronic Quality Management System (eQMS)

In accordance with regulation 86 and 87 of the Public Contracts Regulations 2015, VMIC incorporated a minimum 10 calendar days standstill period starting from the day when contract award was notified to the bidders. Unsuccessful bidders were provided with a de-brief of the award decision at the start of the standstill period including details of their bid in relation to the winning bid(s) comprising:

— the reasons for the decision;

— the characteristics and relative advantages of the successful tender(s);

— the score and name of the economic operator(s) to be awarded the contract.

Bidders have the right to appeal provided for within the Public Contract Regulations 2015. Any such proceedings must be brought before the High Court of England and Wales.