The Supply and Implementation of a Quality Management System

Cell & Gene Therapy Catapult (CGTC) is part of a world-leading network of technology and innovation centres, established in December 2012 and now with over 100 employees, we believe through science and industry, our expertise in cell and gene therapies will one day provide better treatments that will help improve patient quality of life whilst building a global industry the UK can be proud of. Our mission to deliver health and wealth is supported by the UK's enviable academic base.

We strive to be a world leader in cell and gene therapy and support those who wish to convert research into products that have the potential to have direct impact in advanced healthcare. CGTC is not alone in this ambition.

Regenerative medicine is one of the government's eight great technologies that support UK science strengths and capabilities. CGTC's offices are located in Guys Hospital in London.

CGTC are building a 55 000 000 GBP large-scale GMP Manufacturing Centre to help bring cell and gene therapies to market in the UK and internationally. It will provide the UK with the manufacturing facilities needed for later-stage cell and gene therapy clinical studies and commercialisation.

The centre benefits from an established supply chain, prime UK location in Stevenage and expert impartial advice from the Cell and Gene Therapy Catapult, enabling the manufacture of therapies to the highest grade, with minimal risk and 100 percent control. This procurement is for the supply, implementation and support of a Quality Management System (QMS) for CGTC.

The QMS solution will cover two sites, primary the manufacturing centre in Stevenage with a subset of system functionality available for use at CGTC's Guys Hospital location. CGTC is committed to implementing an EQMS system as a priority by May 2017 in time for the opening of the Manufacturing Centre in July 2017.

Completion of formal GMP system qualification would be required to be completed no later than November 2017 in anticipation of inspection for licensure in December 2017. The QMS solution modules will include document control (end-to-end GMP lifecycle management), Deviation Management, CAPA, Audit Management, Training and Compliance, Change Control, workflow functionality along with associated supporting API interfaces and the capability to accommodate the addition of other user configured workflows at a later date. The potential budget for the EQMS system is between 400 000 GBP — 900 000 GBP total excluding VAT for the potential 5 year contract (3 years initially plus two further periods of up to 24 months).