Quality Management System

Description

The Hospital Pharmacy of Region North Denmark has initiated a process of selecting a new Quality Management System (QMS). The Hospital Pharmacy is looking for a solution integrating document management and training with the most important quality processes such as deviations and CAPA management, change management, and complaints management. Furthermore, the solution must present dashboard-type key figures graphically with drill-down functionality to single registrations. The Hospital Pharmacy is looking for an eQMS 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, 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 solution must come with ready-to-use standard functionality and configuration possibilities to fulfill critical business demands in life-science. The solution must be a validation-ready system and comply with European regulations for GMP production and GDP. The solution must stay accessible, current, and in context with development, technology and future commercial regulatory needs within the life science industry standard, continuously ensuring quality and optimal performance.