Section one: Contracting authority
one.1) Name and addresses
Vaccines Manufacturing and Innovation Centre (UK) Limited
Harwell Campus
Didcot
OX11 ORH
Contact
Chris Peterson
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
Buyer's address
https://www.vmicuk.com/about-us
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://www.vmicuk.com/tenders
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted to the above-mentioned address
one.4) Type of the contracting authority
Other type
Vaccine Manufacture Development
one.5) Main activity
Other activity
Vaccination Manufacture Development
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Enterprise Resource Planning (ERP) solution
Reference number
2021-VMIC-001-ERP
two.1.2) Main CPV code
- 72212451 - Enterprise resource planning software development services
two.1.3) Type of contract
Services
two.1.4) Short 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.
two.1.5) Estimated total value
Value excluding VAT: £7,000,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 30000000 - Office and computing machinery, equipment and supplies except furniture and software packages
- 48451000 - Enterprise resource planning software package
- 72266000 - Software consultancy services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
Main site or place of performance
Harwell Campus
Didcot
Oxon
OX11 ORH
two.2.4) Description of the procurement
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.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
84
This contract is subject to renewal
Yes
Description of renewals
Initial 3 year term with options to extend. Potentially, 3 years + 2 years + 2 years = 7 year term. The value quoted in this notice is the anticipated maximum value for the full potential 7 year term. Any renewal/extension is entirely at VMIC discretion and subject to VMIC sole assessment of satisfactory performance. It should be noted that the VMIC default position is that any extension will be on firm or fixed terms/rates or improved terms/rates.
two.2.9) Information about the limits on the number of candidates to be invited
Envisaged minimum number: 5
Maximum number: 8
Objective criteria for choosing the limited number of candidates:
Please refer to the Standard Selection Questionnaire (SQ)
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: Yes
Description of options
Initial 3 year term with options to extend. Potentially, 3 years + 2 years + 2 years = 7 year term. The value quoted in this notice is the anticipated maximum value for the full potential 7 year term. Any renewal/extension is entirely at VMIC discretion and subject to VMIC sole assessment of satisfactory performance.It should be noted that the VMIC default position is that any extension will be on either firm or fixed terms/rates or improved terms/rates.
An option to add a Human Resources module at a later date.
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions
Please refer to the Standard Selection Questionnaire (SQ)
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
three.2) Conditions related to the contract
three.2.2) Contract performance conditions
Please refer to the Standard Selection Questionnaire (SQ)
three.2.3) Information about staff responsible for the performance of the contract
Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Restricted procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
9 April 2021
Local time
5:00pm
four.2.3) Estimated date of dispatch of invitations to tender or to participate to selected candidates
4 May 2021
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 6 (from the date stated for receipt of tender)
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.3) Additional information
VMIC does not support full electronic transaction capability at present. Deployment of the solution per this notice will facilitate this future capability.
six.4) Procedures for review
six.4.1) Review body
Vaccines Manufacturing & Innovation Centre (UK) Ltd
Harwell Campus
Didcot
OX11 0RH
Country
United Kingdom