ABSTRACT

Digitization influences all facets of our lives. Technology has been an essential part of the pharmaceutical industry in recent years. Every day, innovations and applications are introduced, resulting in a more sophisticated mode of communication. As a result, changes in consumer dynamics push the pharmaceutical industry to take the required measures to secure strong technological support that increases drug production and quality of life. A stable operating software system is updated regularly to minimize human error. Since the pharmaceutical industry operates in a highly organized environment, efficient data protection systems are necessary to prevent data integrity. The regulatory affairs professionals use semi-regulated systems, non-specialized software, organization-developed databases, and manual systems to support their daily operations. These ineffective methods handleseach product portfolio manually, resulting in unintentionalconcerns. Besides the strict regulatory environment, pharmaceutical companies must adopt a “Regulatory Information Management System” to handle the growing amount of data. The study below describes the prominent role of a regulatory information management system in the pharmaceutical industry to ensure data consistency and credibility as a requirement for implementing a risk management system. The main motto is to highlight the regulator’s draught for the introduction and growth of “Regulatory Information Management”in pharmaceutical companies. Keywords: Regulatory Management; Management Software; Modernization key; Attributes of software; Regulatory Compliance
Publication date: 01/02/2022

https://ijbpas.com/pdf/2022/February/MS_IJBPAS_2022_5902.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.2.5902