Public procurement notice: Prior Information Notice Without Call For Competition
Published: 2023-06-21
Buyer: Region Nordjylland
Country: DK
Contract type: Services
CPV classification: 72000000 | 72200000

Technical requirements: Υπηρεσίες τεχνολογίας των πληροφοριών: παροχή συμβουλών, ανάπτυξη λογισμικού, Διαδίκτυο και υποστήριξη
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 purpose of this Market Analysis is to describe the high-level requirements for the next generation of an electronic Quality Management System (eQMS) for the Hospital Pharmacy North Denmark Region.   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 purpose of this Market Analysis is to describe the high-level requirements for the next generation of an electronic Quality Management System (eQMS) for the Hospital Pharmacy North Denmark Region:
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.