Validation Services

This URS prospectively defines the requirements for the provision of Validation Management Services in the IBTS. The general activities to be carried out by this service within the IBTS will include, but will not be confined to: • To manage all operational Validation activities within the organisation • To continue …

CPV: 51430000 Installation av laboratorieutrustning, 51410000 Installation av medicinsk utrustning, 50400000 Reparation och underhåll av medicinsk utrustning och precisionsutrustning
Sista ansökningsdag:
28 april 2025 12:00
Typ av tidsfrist:
Inlämnande av anbud
Plats för avrättning:
Validation Services
Plats för tilldelning:
Irish Blood Transfusion Service
Tilldelningsnummer:
0

1. Buyer

1.1 Buyer

Official name : Irish Blood Transfusion Service
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Validation Services
Description : This URS prospectively defines the requirements for the provision of Validation Management Services in the IBTS. The general activities to be carried out by this service within the IBTS will include, but will not be confined to: • To manage all operational Validation activities within the organisation • To continue to develop and implement a compliant Validation strategy for the IBTS; • To enhance and further establish the Validation Department within the IBTS; • To continue to develop and implement an efficient, compliant and cost-effective calibration and maintenance programme; • To report on-going performance of Validation activities to the Director of Quality and Compliance. • Be capable of delivering high level reporting to Executive and Senior Management. • Manage all facets of assigned Validation projects while maintaining strong communication with stakeholders on project status and assistance needed. • To contribute Validation expertise to other project activities where required. • To manage scheduling, planning and review of Validation activities for the Validation department, including on training and skills development; • To work closely with the Quality and Compliance Department and all departments to ensure the operation of a validated environment according to GMP and other regulatory requirements. • Manage and maintain all relevant service, maintenance and calibration contracts.
Procedure identifier : b2cade91-6b1f-44e4-aa78-3871afde62a6
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 51430000 Installation services of laboratory equipment
Additional classification ( cpv ): 51410000 Installation services of medical equipment
Additional classification ( cpv ): 50400000 Repair and maintenance services of medical and precision equipment

2.1.2 Place of performance

Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland

2.1.3 Value

Estimated value excluding VAT : 260 000 Euro

2.1.4 General information

Legal basis :
Directive 2014/24/EU

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Validation Services
Description : This URS prospectively defines the requirements for the provision of Validation Management Services in the IBTS. The general activities to be carried out by this service within the IBTS will include, but will not be confined to: • To manage all operational Validation activities within the organisation • To continue to develop and implement a compliant Validation strategy for the IBTS; • To enhance and further establish the Validation Department within the IBTS; • To continue to develop and implement an efficient, compliant and cost-effective calibration and maintenance programme; • To report on-going performance of Validation activities to the Director of Quality and Compliance. • Be capable of delivering high level reporting to Executive and Senior Management. • Manage all facets of assigned Validation projects while maintaining strong communication with stakeholders on project status and assistance needed. • To contribute Validation expertise to other project activities where required. • To manage scheduling, planning and review of Validation activities for the Validation department, including on training and skills development; • To work closely with the Quality and Compliance Department and all departments to ensure the operation of a validated environment according to GMP and other regulatory requirements. • Manage and maintain all relevant service, maintenance and calibration contracts.
Internal identifier : 0

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 51430000 Installation services of laboratory equipment
Additional classification ( cpv ): 51410000 Installation services of medical equipment
Additional classification ( cpv ): 50400000 Repair and maintenance services of medical and precision equipment

5.1.2 Place of performance

Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Additional information : 0000

5.1.3 Estimated duration

Other duration : Unknown

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.7 Strategic procurement

Aim of strategic procurement : No strategic procurement

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : English
Languages in which the procurement documents (or their parts) are unofficially available : English

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Tenderers may submit more than one tender : Not allowed
Deadline for receipt of tenders : 28/04/2025 12:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 28/04/2025 12:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : The High Court of Ireland -
Information about review deadlines : 0000
Organisation providing offline access to the procurement documents : Irish Blood Transfusion Service -
Organisation receiving requests to participate : Irish Blood Transfusion Service -
Organisation processing tenders : Irish Blood Transfusion Service -

8. Organisations

8.1 ORG-0001

Official name : Irish Blood Transfusion Service
Registration number : 007952H
Postal address : National Blood Centre James's Street Dublin
Town : Dublin
Postcode : D08 NH5R
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : 0858310894
Internet address : https://www.giveblood.ie
Roles of this organisation :
Buyer
Organisation providing offline access to the procurement documents
Organisation receiving requests to participate
Organisation processing tenders

8.1 ORG-0002

Official name : The High Court of Ireland
Registration number : The High Court of Ireland
Department : The High Court of Ireland
Postal address : Four Courts, Inns Quay, Dublin 7
Town : Dublin
Postcode : D07 WDX8
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : +353 1 8886000
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Dynamics S.A.
Registration number : 002024901000
Department : European Dynamics S.A.
Town : Athens
Postcode : 15125
Country subdivision (NUTS) : Βόρειος Τομέας Αθηνών ( EL301 )
Country : Greece
Telephone : +30 2108094500
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : f4894b36-72b1-4a81-8588-28c1dcfb8b2a - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 20/03/2025 15:23 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00187506-2025
OJ S issue number : 58/2025
Publication date : 24/03/2025