Project Management in Risk Analysis for Validation of Computer Systems in the Warehouse System

Author:

Magalhães Jorge Lima de1ORCID,Igarashi Juliana Satie Oliveira2,Hartz Zulmira3,Antunes Adelaide Maria de Souza4,Macedo Elizabeth Valverde5ORCID

Affiliation:

1. Instituto de Tecnologia em Fármacos Farmanguinhos, Brazil

2. Daudt Oliveira Pharmaceutical Laboratory, Brazil

3. Institute of Hygiene and Tropical Medicine (IHMT). GHTM, NOVA University of Lisbon, Portugal

4. National Institute for Industrial Property & Chemical School, University of Rio de Janeiro, Brazil

5. Federal Fluminense University (UFF), Brazil

Abstract

The informational and digital era of Big Data presents a non-trivial and unprecedented way in history for data and information management in organizations. Thus, to manage, protect, and ensure the validation of this data, it is imperative to develop new technologies for project management and their respective implementation in organizations. This chapter shows a case study in a pharmaceutical industry with the proposition of a methodology for validation of emerging technologies in the computerized systems. Data validation and security for project management in the organization is increasingly in demand. So, this implies that time and human resources in organizations are not infinite. It is necessary to prioritize the activities and resources dedicated to maintaining the validated state of the system. Authors propose a risk analysis to help companies with validation. They also present a proposed methodology for risk analysis from the point of view of the validation of computerized systems in a Warehouse Management module in a validated SAP ERP.

Publisher

IGI Global

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3. ANVISA. Agência Nacional de Vigilância Sanitária. Disponível em http://portal.anvisa.gov.br/

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