Pharmaceutical companies are increasingly adopting or considering computerized systems such as Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS) to ensure the reliability of drug manufacturing processes.

However, simply implementing these systems does not guarantee reliability. It necessitates robust IT literacy among users, the cultivation of a strong quality culture, and a deep understanding of both input data accuracy and system vulnerabilities.

This article aims to provide insights for pharmaceutical companies considering or implementing computerized systems by discussing the benefits, drawbacks, and specific considerations regarding system integration based on our company's experience with implementing MES and LIMS for drug manufacturing.

Our group has studied the procedure for the development of a unified risk assessment and environmental monitoring program in aseptic process isolator systems, based on the grid profiling approach (BioPhorum's Approach). We adopted the REM/I-REM approach for risk assessment in grid profiling and incorporated airflow visualisation studies into this. The purpose of airflow visualisation studies is not only to assess qualification, but also to develop a product/process contamination control strategy based on a risk assessment that takes into account the results of the study.