Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Aishwarya Nale, Aishwarya Mali, Sandhya Kadam, Vivekkumar Redasani

Abstract: The purpose of documents as a data source in qualitative research is examined in this article, which also explores document analysis procedures in the context of real-life research experiences. The paper, which is aimed at research beginners, presents a step-by-step method for document analysis. It discusses the nature and types of documents, as well as the Advantages and method of document analysis, and provides concrete instances of how documents might be used in the research process. A grounded theory study is used to demonstrate the use of document analysis. We may notice major trends in information systems that have an impact on their evolution, including documentation. As a result, the approaches to systems from the perspectives of IT project management, roles, and resource allocation, as well as the relevance of documentation for the success of a development project, have changed.

Keywords: Documentation, Batch manufacturing record (BMR), Manufacturing formula record (MFR), Standard operating procedure (SOP), Good documentation practices (GDP), and Quality audit.