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EPQMS PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM

NHS Wales Shared Services Partnership-Procurement Services (hosted by Velindre University NHS Trust)

This public procurement record has 2 releases in its history.

Award

16 Jul 2026 at 14:37

UK7 - Contract Details Notice
Award

05 Dec 2025 at 14:16

UK5 - Transparency Notice
Summary of the contracting process

NHS Wales Shared Services Partnership-Procurement Services, hosted by Velindre University NHS Trust, procured an electronic Pharmaceutical Quality Management System (ePQS) for NHS Wales Pharmacy Technical Services. The system supports the manufacture and aseptic preparation of medicines, including activities at the TrAMs hubs and the new Radiopharmacy aseptic unit at IP5. Its scope covers a regulatory-compliant digital quality system for quality assurance, validation, electronic records management, audit trails, data integrity and related support. This is an IT software, consulting, development and support service (CPV 72000000), delivered for NHS Wales operations in the United Kingdom. The requirement is intended to maintain safe, effective and uninterrupted patient supply within a highly regulated pharmaceutical manufacturing environment overseen by the Medicines and Healthcare products Regulatory Agency.

The procurement is complete and has been awarded through a direct award without competition, described as below threshold. NHS Wales Shared Services Partnership awarded Bizzmine UK Limited the ePQS service for £94,080 excluding VAT, or £112,896 including VAT. The award was recorded as active, and the contract was signed on 30 June 2026. The contract period runs from 1 July 2026 to 23 February 2030; the award record gives an associated period from 26 February 2026 to 25 February 2030. There is one completed lot. The direct award was justified under Schedule 5 paragraph 7 of the Procurement Act 2023 because changing supplier would create incompatibility and disproportionate technical difficulties, including extensive redesign, validation and revalidation under pharmaceutical manufacturing requirements.

This requirement is relevant to suppliers specialising in electronic quality management systems for pharmaceutical manufacturing, aseptic preparation, radiopharmacy or other highly regulated healthcare environments. A credible competitor would need to provide software and support that can maintain compliant electronic records, reliable audit trails, strong data-integrity controls, quality assurance workflows and validation evidence aligned with MHRA expectations and EU GMP requirements, including Annexes 1 and 11. Experience of configuring, qualifying and supporting systems through regulated validation is important, as is the capacity to protect continuity of operation while supporting complex manufacturing hubs. The award also shows that this buyer values an established, supportable platform whose replacement would not create unacceptable compliance, technical or operational risk.

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Notice Information

Notice Title

EPQMS PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM

Notice Description

NHS Wales Shared Services Partnership Pharmacy Technical Services provide a wide range of activities essential to patient care, including the manufacture and aseptic preparation of medicines. These services operate within a highly regulated framework overseen by the Medicines and Healthcare products Regulatory Agency (MHRA) and must comply with Good Manufacturing Practice (GMP) standards and Data Integrity requirements. A robust and compliant Pharmaceutical Quality System (PQS) is therefore fundamental to ensuring safe, effective, compliant, and uninterrupted patient supply.Recent regulatory updates (EU GMP Chapter 4, Annex 1) place greater emphasis on the strength of PQS in supporting quality assurance, validation, and data management. Traditional manual or paper-based processes are no longer sufficient to meet MHRA expectations. To address this, an Electronic PQS (ePQS), Bizzmine, has been procured in line with a comprehensive set of Functional Specification Requirements. This system provides a resilient, regulatory-compliant solution tailored for the TrAMs hubs, including the new Radiopharmacy aseptic unit at IP5.Retention of the current ePQS software platform is essential to maintain regulatory compliance. Any change of system would necessitate a full redesign and revalidation in line with MHRA Good Manufacturing Practice and Annexes 1 and 11 of the EU GMP Guide, including comprehensive qualification and revalidation of all functions and processes. Given the complexity of these requirements, the design and validation of the current Pharmaceutical Quality System has already taken over two years; repeating this process would introduce significant compliance risks and cause substantial delays to the Radiopharmacy build.The existing system has been configured and is undergoing validation to fully meet Annex 1 and Annex 11 requirements, including electronic records management, audit trails, and data integrity safeguards. Continuing with this platform avoids duplication of effort, ensures uninterrupted compliance, and mitigates the risk of regulatory findings that could compromise unit approval.Procurement of an alternative ePQS software solution is not feasible given the regulatory framework and extensive revalidation requirements. The incumbent supplier is the sole provider capable of delivering the licences and support needed to maintain the current ePQS in an operational and compliant state. In light of this NHS Wales Shared Services Partnership are looking to undertake a direct award with the incumbent suppliers via a Direct Award under Schedule 5 paragraph 7 of the Procurement Act 2023 'The public contract concerns the supply of goods, services or works by the existing supplier which are intended as an extension to, or partial replacement of, existing goods, services or works in circumstances where--(a)a change in supplier would result in the contracting authority receiving goods, services or works that are different from, or incompatible with, the existing goods, services or works, and(b)the difference or incompatibility would result in disproportionate technical difficulties in operation or maintenance'.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-05efdb
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/067319-2026
Current Stage
Award
All Stages
Award

Procurement Classification

Notice Type
UK7 - Contract Details Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Direct
Procurement Method Details
Below threshold - without competition
Tender Suitability
Not specified
Awardee Scale
SME

Common Procurement Vocabulary (CPV)

CPV Divisions

72 - IT services: consulting, software development, Internet and support

CPV Codes

72000000 - IT services: consulting, software development, Internet and support

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
£94,080 Under £100K
Contracts Value
£94,080 Under £100K

Notice Dates

Publication Date
16 Jul 20261 months ago
Submission Deadline
Not specified
Future Notice Date
Not specified
Award Date
5 Dec 20258 months ago
Contract Period
1 Jul 2026 - 23 Feb 2030 3-4 years
Recurrence
Not specified

Notice Status

Tender Status
Complete
Lots Status
Complete
Awards Status
Active
Contracts Status
Active

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
NHS Wales Shared Services Partnership-Procurement Services (hosted by Velindre University NHS Trust)
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
CARDIFF
Postcode
CF14 3UZ
Postcode Area
Cardiff
Country
Wales
Major Region (ITL 1)
TLL Wales
Basic Region (ITL 2)
TLL5 South East Wales
Small Region (ITL 3)
TLL52 Cardiff and Vale of Glamorgan
Delivery Location
Not specified
Local Authority
Cardiff
Electoral Ward
Gabalfa
Westminster Constituency
Cardiff North

Supplier Information

Number of Suppliers
1
Supplier Name

Bizzmine UK Limited

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

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