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Records management and archiving in the pharmaceutical industry and regulatory authorities

This article describes the processes that take place in the pharmaceutical regulatory environment and documentation on medicinal products. Granting of marketing authorization and other regulatory processes use dossiers on medicinal products as their primary resources. The pharmaceutical industry moved from paper to digital marketing authorization dossiers. The article discusses the tasks of those responsible for managing documentation in the pharmaceutical industry and regulatory agencies. There are people with various job roles who work on the dossiers on medicinal products in the companies and agencies, but they are primarily focused on the content. In most pharmaceutical and regulatory organizations, medicinal products dossiers must be kept for the long term or permanently. Hence, records managers and archivists are most welcome to work in this milieu. In this respect, the article outlines the competencies necessary for managing digital records and dossiers on medicinal products. Finally, the article explores future trends in archiving pharmaceutical documentation and proposes necessary standards and mechanisms for the task, as well as the information model of submission and archival information packages for this domain.

Digital archives ; dossiers on medicinal products ; electronic common technical document ; pharmaceutical industry ; regulatory agencies

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