Supply and Implementation of a Quality Management System

Supply and Implementation of a Quality Management System

This procurement is for the supply, implementation and support of a Quality Management System for CGTC.

United Kingdom-London: Software package and information systems

2016/S 159-287679

Contract notice

Services

Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses

Cell and Gene Therapy Catapult
12th Floor, Guy’s Tower, Great Maze Pond
London
SE1 9RT
United Kingdom
E-mail: MCProcurement@ct.catapult.org.uk
NUTS code: UKI1

Internet address(es):Main address: https://ct.catapult.org.uk/

I.2)Joint procurement

I.3)Communication

Access to the procurement documents is restricted. Further information can be obtained at: https://ct.catapult.org.uk
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted to the abovementioned address

I.4)Type of the contracting authority

Other type: partially funded through another contracting authority

I.5)Main activity

Other activity: cell and gene therapies

Section II: Object

II.1)Scope of the procurement

II.1.1)Title:

The Supply and Implementation of a Quality Management System.

Reference number: CON-0082

II.1.2)Main CPV code

48000000

II.1.3)Type of contract

Services

II.1.4)Short description:

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. The system is to be supplied and implemented to CGTC’s requirements 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.

II.1.5)Estimated total value

Value excluding VAT: 900 000.00 GBP

II.1.6)Information about lots

This contract is divided into lots: no
II.2)Description
II.2.1)Title:
II.2.2)Additional CPV code(s)

II.2.3)Place of performance

NUTS code: UKH23
Main site or place of performance:

Stevenage.

II.2.4)Description of the procurement:

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).

II.2.5)Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6)Estimated value

Value excluding VAT: 900 000.00 GBP

II.2.7)Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 60
This contract is subject to renewal: no

II.2.10)Information about variants

Variants will be accepted: no

II.2.11)Information about options

Options: no
II.2.12)Information about electronic catalogues

II.2.13)Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

II.2.14)Additional information

To express an interest to received the tender documents you must provide your contact name, position in company, company name, address, email and mobile phone contact details and a brief summary of your experience of providing such systems to MCProcurement@ct.catapult.org.uk

Section III: Legal, economic, financial and technical information

III.1)Conditions for participation
III.1.1)Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers

III.1.2)Economic and financial standing

Selection criteria as stated in the procurement documents

III.1.3)Technical and professional ability

Selection criteria as stated in the procurement documents
III.1.5)Information about reserved contracts
III.2)Conditions related to the contract
III.2.1)Information about a particular profession
III.2.2)Contract performance conditions:
III.2.3)Information about staff responsible for the performance of the contract

Section IV: Procedure

IV.1)Description

IV.1.1)Type of procedure

Open procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing system
IV.1.4)Information about reduction of the number of solutions or tenders during negotiation or dialogue
IV.1.6)Information about electronic auction

IV.1.8)Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: yes
IV.2)Administrative information

IV.2.1)Previous publication concerning this procedure

Notice number in the OJ S: 2016/S 112-198761

IV.2.2)Time limit for receipt of tenders or requests to participate

Date: 22/09/2016
Local time: 14:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates

IV.2.4)Languages in which tenders or requests to participate may be submitted:

English

IV.2.6)Minimum time frame during which the tenderer must maintain the tender

Duration in months: 3 (from the date stated for receipt of tender)

IV.2.7)Conditions for opening of tenders

Date: 22/09/2016
Local time: 14:00

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no
VI.2)Information about electronic workflows
VI.3)Additional information:
VI.4)Procedures for review

VI.4.1)Review body

Cell & Gene Therapy Catapult
London
SE1 9RT
United Kingdom
VI.4.2)Body responsible for mediation procedures
VI.4.3)Review procedure
VI.4.4)Service from which information about the review procedure may be obtained

VI.5)Date of dispatch of this notice:

17/08/2016

 

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