Validation Consultancy Contract
Validation Consultancy Contract
The Awarding Authority is seeking to procure specialist resources/consultancy support to validate the functionality of the NHS Wales Laboratory Information System (LIMS) the Good Automated Manufacturing practice (GAMP) guidelines and safety requirements stipulated by the Medicines and Healthcare Products Regulation Agency (MHRA).
UK-Bridgend: technical testing, analysis and consultancy services
Section I: Contracting authority
I.1)Name, addresses and contact point(s)
Velindre NHS Trust (as hosts of the NHS Wales Informatics Service)
10-11 Oldfield Road, Bocam Park, Pencoed
For the attention of: Julie Francis
CF31 2DD Bridgend
Telephone: +44 1656778903
Fax: +44 1656865187
Further information can be obtained from: The above mentioned contact point(s)
Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)
Tenders or requests to participate must be sent to: The above mentioned contact point(s)
I.2)Type of the contracting authority
Body governed by public law
I.4)Contract award on behalf of other contracting authorities
The contracting authority is purchasing on behalf of other contracting authorities: yes
Section II: Object of the contract
II.1.1)Title attributed to the contract by the contracting authority:
Validation Consultancy Procurement.
II.1.2)Type of contract and location of works, place of delivery or of performance
Service category No 11: Management consulting services  and related services
Main site or location of works, place of delivery or of performance: Primarily located in NHS Wales Informatics Service (further information on location as set out in the contract documents).
NUTS code UK
II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)
The notice involves a public contract
II.1.4)Information on framework agreement
II.1.5)Short description of the contract or purchase(s)
Contract for Specialist Validation Resources.
II.1.6)Common procurement vocabulary (CPV)
71600000, 72220000, 71621000
II.1.7)Information about Government Procurement Agreement (GPA)
The contract is covered by the Government Procurement Agreement (GPA): yes
This contract is divided into lots: no
II.1.9)Information about variants
Variants will be accepted: yes
II.2)Quantity or scope of the contract
II.2.1)Total quantity or scope:
The Awarding Authority is seeking to procure specialist resources/consultancy support to validate the functionality of the NHS Wales Laboratory Information System (LIMS) the Good Automated Manufacturing practice (GAMP) guidelines and safety requirements stipulated by the Medicines and Healthcare Products Regulation Agency (MHRA). Within this activity, the LIMS software and documentation will be formally reviewed, categorised and validation approach documented This work will include specific validation tasks as detailed below:
— Lead on validation activities for Implementation phases,
— Support Delivery of Blood Transfusion project plan,
— Support Delivery of the Validation plan for the application,
— Review Blood Transfusion Testing workstream,
— Direct project risk assessments,
— Co-ordinate validation sign off process,
— Oversee control points within the Validation Project Plan,
— Support Data Migration workstream,
— Support development of required procedures,
— Lead Qualification protocol reviews, (IQ,PQ,OQ),
— Produce Reports,
— Develop and manage checklist for site readiness.
Further details concerning the scope and nature of the requirement shall be included with subsequent documentation.
II.2.2)Information about options
II.2.3)Information about renewals
II.3)Duration of the contract or time limit for completion
Duration in months: 36 (from the award of the contract)
Section III: Legal, economic, financial and technical information
III.1)Conditions relating to the contract
III.1.1)Deposits and guarantees required:
As set out in the Invitation to Tender (ITT) documents. The Contracting Authority reserves the right to request parent company and/or other guarantees of financial liability.
III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:
As set out in the ITT documents.
III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:
None specified save that in the case of a partnership or consortia or other groups of more than one legal entity, liability shall be joint and several. In the case of consortia, one party must act as a prime contractor.
III.1.4)Other particular conditions
The performance of the contract is subject to particular conditions: no
III.2)Conditions for participation
III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers
Information and formalities necessary for evaluating if the requirements are met: Suppliers Instructions How to Express Interest in this Tender~:
1. Register your company on the eSourcing portal (this is only required once) – Browse to the eSourcing Portal: https://etenderwales.bravosolution.co.uk/whs
and click the link to register – Accept the terms and conditions and click ‘continue’ – Enter your correct business and user details – Note the username you chose and click ‘Save’ when complete – You will shortly receive an email with your unique password (please keep this secure)
2. Express an Interest in the tender – Login to the portal with the username/password – Click the ‘PQQs / ITTs Open To All Suppliers’ link. (These are Pre-Qualification Questionnaires or Invitations to Tender open to any registered supplier) – Click on the relevant PQQ/ ITT to access the content. – Click the ‘Express Interest’ button at the top of the page. – This will move the PQQ /ITT into your ‘My PQQs/ My ITTs’ page. (This is a secure area reserved for your projects only) -You can now access any attachments by clicking ‘Buyer Attachments’ in the ‘PQQ/ ITT Details’ box
3. Responding to the tender – Click ‘My Response’ under ‘PQQ/ ITT Details’, you can choose to ‘Create Response’ or to ‘Decline to Respond’ (please give a reason if declining) – You can now use the ‘Messages’ function to communicate with the buyer and seek any clarification – Note the deadline for completion, then follow the onscreen instructions to complete the PQQ/ ITT – There may be a mixture of online & offline actions for you to perform (there is detailed online help available) You must then submit your reply using the ‘Submit Response’ button at the top of the page. If you require any further assistance please consult the online help, or contact the eTendering help desk.
III.2.2)Economic and financial ability
Information and formalities necessary for evaluating if the requirements are met: As set out in the PQQ.
Minimum level(s) of standards possibly required: As set out in the PQQ.
Information and formalities necessary for evaluating if the requirements are met:
As set out in the PQQ.
Minimum level(s) of standards possibly required:
As set out in the PQQ.
III.2.4)Information about reserved contracts
III.3)Conditions specific to services contracts
III.3.1)Information about a particular profession
Execution of the service is reserved to a particular profession: no
III.3.2)Staff responsible for the execution of the service
Section IV: Procedure
IV.1)Type of procedure
IV.1.1)Type of procedure
IV.1.2)Limitations on the number of operators who will be invited to tender or to participate
Envisaged minimum number 3: and maximum number 6
Objective criteria for choosing the limited number of candidates: As set out in the PQQ.
IV.1.3)Reduction of the number of operators during the negotiation or dialogue
The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document
IV.2.2)Information about electronic auction
An electronic auction will be used: no
IV.3.1)File reference number attributed by the contracting authority:
IV.3.2)Previous publication(s) concerning the same contract
IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document
IV.3.4)Time limit for receipt of tenders or requests to participate
12.7.2012 – 12:00
IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates
IV.3.6)Language(s) in which tenders or requests to participate may be drawn up
IV.3.7)Minimum time frame during which the tenderer must maintain the tender
IV.3.8)Conditions for opening tenders
Section VI: Complementary information
VI.1)Information about recurrence
This is a recurrent procurement: no
VI.2)Information about European Union funds
The contract is related to a project and/or programme financed by European Union funds: no
The Contracting Authority will not accept completed PQQ’s after the stated closing date.
All tender costs and liabilities incurred by bidders shall be the sole responsibility of the bidders.
The Contracting Authority reserves the right to award the contract in whole, in part or annul the tendering process and not award any contract.
All documents to be priced (where applicable) in sterling and all payments made in sterling.
In relation to Section II.1.9 above – variants will be accepted to the extent permitted in the ITT (if at all).
The tendering process may be undertaken in part via electronic means using the Bravo e-tendering system.
The initial term of the contract will be 12 months with the option to extend for a further 2 periods each of 1 year.
The Authority is acting on behalf of NHS Wales organisations including (but not limited to) Local Health Boards, NHS Trusts and the NHS Wales Informatics Service.
VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures
VI.4.2)Lodging of appeals
Precise information on deadline(s) for lodging appeals: The Authority will allow a minimum 10 calendar day standstill period between notifying the award decision and awarding the contract. Unsuccessful tenderers and applicants are entitled to receive reasons for the decision, including the characteristics and relative advantages of the winning bid and the reasons why the tenderer/applicant was unsuccessful. Should additional information be required it should be requested of the addressee in section I.1. Aggrieved parties who have been harmed or are at risk of harm by breach of the procurement rules have the right to take action in the High Court (England and Wales). Any such action is subject to strict time limits and must be brought promptly in accordance with the Public Contracts (Amendments) Regulations 2009.
VI.4.3)Service from which information about the lodging of appeals may be obtained
VI.5)Date of dispatch of this notice:7.6.2012