Dennis Sandkühler

The demands on manufacturers in the pharmaceutical industry are constantly increasing. Global competition and the international production and supply of raw materials and active ingredients increase the complexity of supply chains.

On the basis of the process-related requirements set out in the specifications, ISPE GAMP® 5 provides for a process risk analysis to identify risks relating to patient safety, product quality, data integrity and compliance requirements.

Fundamentally, the use of computerised systems in GxP environments requires a consideration of regulatory requirements.

The rapid development of information technology has made computer-based systems indispensable in the pharmaceutical and biotechnology industries. They are crucial for managing and processing sensitive data, controlling and monitoring production, and complying with regulations. With increasing digitalisation, there is a growing need to protect these systems from potential threats and ensure that they meet regulatory requirements. In today's feature, Dennis Sandkühler explains why the implementation and subsequent commissioning of computerised systems require careful planning and continuous monitoring, and which aspects you should consider.