Case Study.

Robust quality management

Establish robust (e)quality management processes and systems in a pharmaceutical manufacturing facility.

The Challenge.

When setting up a new pharmaceutical production facility, the requirements for the individual departments are well known. Nevertheless, especially in the pharmaceutical industry, all areas are subject to highly regulated quality requirements that must be met throughout the entire process chain.

In this project, quality processes were defined and the quality systems were robustly set up. When defining process flows, all relevant steps, time sequences and responsibilities were taken into account. When appropriate, defined processes were transferred to digital eQMS softwares. These eQMS softwares guide employees through the processes and ensure that processes are traceable, complete and correctly timed. In addition, overlapping interfaces were identified and coordinated with each other.

The Benefits.

  • Evaluation of existing quality processes and systems
  • Establish sound process flows
  • Implementation of sustainable eQMS systems
  • Coordination of internal interfaces
  • Training employees in new processes and systems

The Outcome.

Cross-company QMS.

Effectively coordinated production and quality processes.

Solid quality processes and systems.

Reliable collection of data in eQMS systems.

Effective processes for employees.

Simplified and complete handling of quality processes by employees.

The Result.

Robust quality processes and systems to capture quality data effectively, completely, and sustainably.