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das Vereinigte Königreich-Oxford: Datenverarbeitungsdienste
Abschnitt I: Öffentlicher Auftraggeber
Abschnitt II: Gegenstand
Software Solution for Quality Control (QC) Micro Environmental Monitoring Data
In setting up the Vaccine Manufacturing and Innovation Centre facility, it is anticipated that VMIC will require a software solution for Quality control (QC) Micro environmental monitoring data.
In setting up the Vaccine Manufacturing and Innovation Centre facility, it is anticipated that VMIC will require a software solution for quality control (QC) Micro environmental monitoring data. The background for the required management of environmental data is laid out below.
The manufacture of the pharmaceutical vaccines must be performed under regulated, controlled conditions. These constant controlled conditions are essential to guarantee a consistent quality of manufactured products. This also applies to the staff working in these clean rooms. Regulatory directives therefore require monitoring of the environmental conditions including viable and non-viable particles and monitoring of the personnel during manufacturing processes. VMIC facility is designed to include cleanrooms and isolators with Grade A to D classification. Process gasses used in the manufacture process will have to be monitored for potential microbial contamination. Furthermore, Water for Injection (WFI) is manufactured within the VMIC facility that must adhere to regulatory standards and requires regular monitoring.
VMIC QC Microbiology will be responsible for the performing of the monitoring of the above stated areas for the qualification of the facility and the WFI plant and will continue to monitor to enable operations in the clean rooms and manufacture of vaccines. To that end, a software solution is sought to enable the organisation and planning of the required monitoring activities; the collation and evaluation of data; transfer of monitoring data collated by external equipment directly into the software system; transfer of selected data to a laboratory information management system (LIMS) for batch release purposes; and the trending of the environmental conditions. This software solution should enable improved data transfer from planning stage through to evaluation stage by providing considerable paperless solutions with guaranteed data integrity.
The contract is for an implementation period followed by 3 years with an option to extend for a further 2 x 12-month periods.
Abschnitt III: Rechtliche, wirtschaftliche, finanzielle und technische Angaben
Abschnitt IV: Verfahren
Abschnitt VI: Weitere Angaben
VMIC considers that this contract may be suitable for economic operators that are small or medium enterprises (SMEs). However, any selection of tenderers will be based solely on the criteria set out for the procurement.
To participate in this procurement candidates must send an expression of interest to Tenders@vmicuk.com. All correspondence and expressions of interest relating to this procurement must be made through this address.
VMIC expressly reserves the right:
(i) not to award any or the whole contract as a result of the procurement process related to the publication of this notice; and
(ii) to make whatever changes it may see fit to the content and structure of the procurement;
(iii) to procure some or all of their needs and requirements covered by this notice outside of this procurement exercise and resulting agreement.
In no circumstances will VMIC be liable for any costs or losses incurred by the candidates.
Any expenditure, work or effort undertaken prior to contract award is accordingly a matter solely for the commercial judgement of the candidate.
In accordance with Regulation 86 and 87 of the Public Contracts Regulations 2015, VMIC will incorporate a minimum 10 calendar days standstill period starting from the day when contract award is notified to the bidders. Unsuccessful bidders will be provided with a de-brief of the award decision at the start of the standstill period including details of their bid in relation to the winning bid(s) comprising:
— the reasons for the decision;
— the characteristics and relative advantages of the successful tender(s);
— the score and name of the economic operator(s) to be awarded the contract.
Bidders have the right to appeal provided for within the Public Contract Regulations 2015. Any such proceedings must be brought before the High Court of England and Wales.