Challenges to the introduction Electronic Records in pharmaceutical companies ～How will it be impacted by the digitization of Manufacturing Records?～

Abstract

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.