Project Name: SAP QM Implementation at Bio-Rad

Industry: Pharmaceutical Industry

Project Description:

Bio-Rad, a leading company in the pharmaceutical industry in the field of blood analysis based in Hercules (USA), carried out an implementation of the SAP Quality Management (QM) module at its site in Cressier (Switzerland). The goal of the project was to optimize and standardize quality management processes to improve quality assurance and meet regulatory requirements.

Main Tasks:

• QM Module Implementation: Introduction and implementation of the SAP QM module.
• Process Design and Realization: Design and implementation of efficient quality management processes.
• Customizing, Testing, and Training: System customization, testing, and user training.

Key Functions and Activities:

• Process Design: Design and optimization of quality management processes.
• QM Core Functionalities: Implementation and customization of the core functions of the QM module.
• QM Customizing: Adaptation and specification of quality management customizing to Bio-Rad's specific requirements.
• Inspection Lots: Management and monitoring of inspection lots.
• Inspection Plans: Creation and management of inspection plans.
• Inspection Characteristics: Definition and management of inspection characteristics.
• Batch Management: Introduction and management of batches for product traceability.
• Quality Notifications: Management and processing of quality notifications.
• QM Interfaces: Setup and customization of interfaces to LIMS (Laboratory Information Management Systems).
• Development of Specifications: Creation of specifications for necessary developments in the SAP system.

Conclusion:

The implementation of the SAP QM module at Bio-Rad in Cressier represents an important step towards improving quality management processes. By adapting and optimizing QM functionalities, Bio-Rad will be able to enhance quality assurance, meet regulatory requirements, and increase the efficiency of quality processes.