A Hybrid Requirements Management Model for Software Development and Acquisition in the Pharmaceutical Industry

• DOI: 10.22533/at.ed.3173362325106

• Palavras-chave: Requirements Engineering, E.R.U. (specification of user requirements), Good Manufacturing Practices (G.M.P), Scrum.

• Keywords: Requirements Engineering, E.R.U. (specification of user requirements), Good Manufacturing Practices (G.M.P), Scrum.

• Abstract:

  Pharmaceutical industries are subject to regulations that value good manufacturing practices (G.M.P). In this context, the area of information technology must provide software capable of complying with industrial needs, following the technical guidelines recommended by software engineering and ANVISA (National Health Surveillance Agency). The objective of this work is, thus, to propose a hybrid requirements management model, applying the Scrum framework for agile project management, in the process of developing and acquiring software for the pharmaceutical industry, merging requirements engineering steps – such as elicitation, analysis and negotiation, documentation, verification and validation of requirements – with the regulatory compliance proposed in the concept phase of the life cycle of ANVISA (National Health Surveillance Agency) computerized systems, with the goal to comply with good manufacturing practices. With this scenario, the pharmaceutical quality assurance area performs qualifications that validate the software's compliance with good manufacturing practices, based on the specification of user requirements (E.R.U.). Finally, a case study compares the results before and after applying the model that was proposed in this work.