Fresenius Kabi benefit from improved CA/PA and document management

Introduction

Based near Oslo in Norway, Fresenius Kabi Ltd specializes in the pharmaceutical manufacture of generic drugs, providing products for organizations worldwide. The FK Halden site is ISO 9001, 13485, 14001, and GMP-certified with FDA approval. The company needed to replace its outdated paper-based system to meet regulatory requirements and manage increasing customer demands. 

The challenge

• Inadequate paper-based systems for managing CA/PA and compliance
• High workload and inefficiencies due to manual processes
• Need for a reliable system to handle regulatory and customer requirements

The solution

Fresenius Kabi selected Ideagen Quality Management for its:

• Robust and stable base, ensuring processes are followed without shortcuts
• Ability to manage CA/PA, document control, and compliance electronically
• Features that improve oversight and visibility of the quality management system

Implementation and impact

Before, Fresenius Kabi struggled with managing compliance and quality processes due to disjointed, manual systems. The transition to Ideagen Quality Management provided an integrated, electronic solution that enhanced operational control and efficiency. This transformation enabled Fresenius Kabi to meet regulatory demands more effectively and improve overall quality management:

• Replaced paper-based processes, reducing staff workload and saving time
• Enhanced visibility and control over CA/PA and document management
• Achieved compliance with ISO, cGMP, and FDA requirements more efficiently
• Improved ability to demonstrate compliance to regulatory bodies and customers
• Maintained high levels of quality and customer satisfaction

Real results

Ideagen Quality Management has significantly enhanced Fresenius Kabi’s CA/PA management and compliance processes, ensuring better efficiency, control, and standardization.

• A Quality Coordinator now saves one hour per day using Ideagen compared with previous paper systems.
• Achieved and maintained compliance with ISO, cGMP, and FDA requirements.
• Gained complete visibility of the entire quality management system, identifying potential issues and overdue actions.