{"id":5015,"date":"2024-11-08T13:24:36","date_gmt":"2024-11-08T13:24:36","guid":{"rendered":"https:\/\/eoswiss-pharma.ch\/digitale-transformation-pharma-copy\/"},"modified":"2024-11-08T13:39:35","modified_gmt":"2024-11-08T13:39:35","slug":"efficiency_increase_administration_validation_qualification","status":"publish","type":"post","link":"https:\/\/eoswiss-pharma.ch\/en\/effizienzsteigerung_administration_validierung_qualifizierung\/","title":{"rendered":"Increased efficiency of administrative processes through optimized qualification and validation"},"content":{"rendered":"

Increased efficiency of administrative processes through optimized qualification and validation<\/strong><\/h1>\r\n

Background<\/strong><\/h2>\r\n

Efficiency in administrative processes is crucial to the success of any organization. In the context of qualification, which comprises the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) steps, as well as the Validation<\/a> new systems, it is clear that this process is extremely demanding and involves many departments. This complexity often leads to numerous meetings, long processing times and sluggish decision-making processes.<\/p>\r\n

Actual state<\/strong><\/h2>\r\n

The qualification processes are clearly defined, with several standard operating procedures (SOPs) describing their implementation in detail. Departments such as Quality, Production, Engineering, Finance and Purchasing work closely together. Nevertheless, the decision-making process - especially for risk analyses - is lengthy and labor-intensive. The preparations for qualification take at least six months, followed by the actual qualification, which is carried out in cooperation with suppliers. After a comprehensive test program, validation is carried out, which is also time-consuming and takes at least six months. These factors lead to a total lead time of often up to twelve months, which greatly impairs the ability to plan and control the overall process.<\/p>\r\n

Negative effects<\/strong><\/h2>\r\n

The tight procedures of the qualification and validation processes cause considerable delays, which have a negative impact on the overall projects. The high personnel commitment costs resulting from the large number of committees lead to unclear financial expenditure. This results in a costly and extremely slow process, which not only leads to a loss of time but also to considerable financial losses.<\/p>\r\n

Our solution and future state<\/strong><\/h2>\r\n

In order to increase efficiency and improve administrative processes, we are aiming for a comprehensive restructuring of the qualification and validation process. The overall process will be divided into various sub-streams that can be processed largely independently of each other. This agile transformation makes it possible to improve the controllability and speed of the processes. By partially loosening the close interlocking of decisions between the various departments, they are given more freedom and responsibility.<\/p>\r\n

Importance of efficiency in agile processes<\/strong><\/h2>\r\n

Efficiency plays a central role in agile processes as it is directly linked to a team's ability to deliver results quickly, cost-effectively and with high quality. The key aspects of efficiency in agile processes are explained below:<\/p>\r\n