Fakta om udbudet
Udbyder
Region Nordjylland
eQMS system til Sygehusapoteket (1)
Region Nordjylland
Voluntary ex ante transparency notice
Services
Section I: Contracting authority/entity
National registration number: 29190941
Postal address: Niels Bohrs Vej 30
Town: Aalborg Ø
NUTS code: DK05 Nordjylland
Postal code: 9220
Country: Denmark
Contact person: Mads Buus-Andersen
E-mail: mbu@rn.dk
Telephone: +45 21596653
Internet address(es):
Main address: http://www.rn.dk
Section II: Object
eQMS system til Sygehusapoteket (1)
The Hospital Pharmacy North Denmark Region is looking for an eQMS solution that allows flexibility across the different aspects of maintaining a regulated environment, however, is consolidated as one enterprise solution without the need for integration or additional manual efforts. We are looking for a Quality platform-based solution that acts as the sole reference point across the enterprise—connecting quality business processes for better visibility, access, and control. The solution must be a cost effective GxP-compliant cloud-based SaaS solution that supports scalability, flexibility and mobility allowing real-time access through a web browser from different devices. Moreover, automatic updates, validation and maintenance should be managed by the software vendor, a robust infrastructure ensuring availability and reliable performance, robust security model installed, and on par with the industry standard for pharma companies.
The Hospital Pharmacy North Denmark Region is looking for an eQMS solution that allows flexibility across the different aspects of maintaining a regulated environment, however, is consolidated as one enterprise solution without the need for integration or additional manual efforts. We are looking for a Quality platform-based solution that acts as the sole reference point across the enterprise—connecting quality business processes for better visibility, access, and control. The solution must be a cost effective GxP-compliant cloud-based SaaS solution that supports scalability, flexibility and mobility allowing real-time access through a web browser from different devices. Moreover, automatic updates, validation and maintenance should be managed by the software vendor, a robust infrastructure ensuring availability and reliable performance, robust security model installed, and on par with the industry standard for pharma companies.
Section IV: Procedure
- The works, supplies or services can be provided only by a particular economic operator for the following reason:
- absence of competition for technical reasons
The eQMS platforms must enable unified end-2-end management of quality processes facilitating seamlessly and automatic transition of data and actions across applications within the platform. The solution should have a modern, easy-to-use interface, to drive higher user adoption with minimal ongoing support. The following core quality processes must be supported by the eQMS platform:
Quality Management Processes: This application must unify quality management business processes across the organization (including external participants). The application must support management of nonconformances, CAPAs, complaints, change controls, lab investigation, audit, inspections, supplier quality management, and quality risk management. The application should offer built-in best practices and automated business process workflows. Native interoperability across the application and platform should streamline quality processes.
Document Lifecycle Management: This application should provide robust document management capabilities, allowing for easy creation, review, approval and version control of GxP controlled content, such as procedures, templates, product specifications, and validation records through the entire document lifecycle. The document management application should allow for collaborative authoring as well as standard lifecycles and automated workflows with a full audit trail.
Training/Learning Management: This application must support the management of quality and compliance-related training, including training needs assessment, training plans creation, tracking of employee training records and automated training assignment and reminders. It should be possible to base training assignment on job roles and responsibilities. Seamless access to training content, managed within the Document Management application must be possible without the need of additional integration.
Validation Management: This application must support the end-to-end digital management of validation and qualifications. Further to support efficiencies and traceability through an inventory of systems, equipment and processes and related requirements, data-centric paperless test execution, and dashboards and summary reports across the enterprise.
Laboratory Information Management System (LIMS): This application must support management of quality control and assurance processes within the laboratory including management of the sample lifecycle, laboratory test and analysis, critical laboratory information, investigation of OOS and OOT results. The primary focus is on environmental monitoring and microbiological process monitoring.
Section V: Award of contract/concession
Postal address: 4280 Haclenda Drive
Town: Pleasanton
NUTS code: US United States
Country: United States
Section VI: Complementary information
Postal address: Nævnenes Hus, Toldboden 2
Town: Viborg
Postal code: 8800
Country: Denmark
E-mail: klfu@naevneneshus.dk
Telephone: +45 72405600
Internet address: https://naevneneshus.dk/start-din-klage/klagenaevnet-for-udbud/
• - In the case of a tender with pre-qualification in accordance with the Public Procurement Act, the Utilities Directive or the Tender Act, a complaint about not having been pre-qualified must be submitted within 20 calendar days. This is calculated from the day after the client sends notification of prequalification.
• - Other complaints about tenders or decisions, e.g. award of contracts, covered by Section II or III of the Public Procurement Act or the Utilities Directive must be submitted 45 calendar days from the day after the contracting authority publishes an order in the EU Official Journal on the conclusion of a contract.
o - If the complaint is about violations of the Tender Act or §§ 191 and 192 of the Tender Act, the complaint deadline is 45 calendar days calculated from the day after the contracting authority is notified of the award decision.
• - Complaints about the conclusion of a framework agreement under the Public Procurement Act (Sections II, III and §§ 191 and 192), the Utilities Directive or the Public Tenders Act must be submitted to the Complaints Board within 6 months from the day after the contracting authority was notified of the award decision.
• - Complaints about the conclusion of a contract based on a framework agreement with re-opening of competition or a dynamic purchasing system covered by Section II or III of the Public Procurement Act or the Utilities Directive must be submitted to the complaints board within 30 calendar days from the day after the contracting authority was notified of the award decision.
• - Complaints about a contracting authority's decision to continue a contract (section 185, subsection 2 of the Public Procurement Act) must be submitted to the complaints board within 20 calendar days from the day after the contracting authority has published its decision (section 185, subsection 2, 3 of the Procurement Act. pt.).
• - If the contracting authority has followed the procedure in the Act on the Complaints Board for Tenders § 4, a complaint that the contracting authority has entered into a contract in violation of the procurement directive or the utility directive without prior publication of a tender notice must be submitted to the complaints board within 30 calendar days from the day after the contracting authority's publication of a notice in the EU Gazette on entering into a contract.
Postal address: Carl Jacobsens Vej 35
Town: Valby
Postal code: 2500
Country: Denmark
E-mail: kfst@kfst.dk
Telephone: +45 41715100
Internet address: http://www.kfst.dk
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