A semantic-driven approach for maintenance digitalization in the pharmaceutical industry.

Area of Science:

• Pharmaceutical Industry
• Digital Transformation
• Quality Management

Background:

• Digital transformation in pharmaceuticals is complex due to regulatory and technical challenges.
• Maintenance activities are critical for ensuring pharmaceutical product quality and operational integrity.
• Existing digitalization efforts face hurdles in maintaining digital continuity for maintenance resources.

Purpose of the Study:

• To identify key challenges in pharmaceutical industry digitalization.
• To propose a semantic-driven digitalization framework for maintenance activities.
• To align pharmaceutical maintenance with Quality 4.0 principles and zero-defect manufacturing goals.

Main Methods:

• Identification of digitalization challenges and problem spaces.
• Development of a semantic-driven digitalization framework.
• Case study validation using water sampling at Merck Serono, Switzerland.
• Presentation of a tool-chain for framework implementation.

Main Results:

• A feasible semantic-driven framework for pharmaceutical maintenance digitalization was verified.
• Key functional modules demonstrated satisfactory performance.
• A digital sampling assistant was developed, supporting automated water sampling workflows.

Conclusions:

• The proposed framework effectively addresses identified problems in pharmaceutical maintenance digitalization.
• The digital sampling assistant showcases the practical application and potential of the framework.
• The framework supports the pharmaceutical industry's transition towards enhanced digital continuity and Quality 4.0.