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Developing Scientific Software According to Pharmaceutical Regulatory Compliance: A GAMP-Based Methodology

Year: 2025

Type: book-chapter

Abstract: Scientific software development in research institutions often focuses on demonstrating technology capabilities, with limited attention to formal documentation. This limits its use beyond academic projects, particularly in pharmaceutical industry collaborations, where Good Manufacturing Practices (GMP) are essential for operational deployment. We propose a methodology based on GMP guidelines tailored for research institutions to bridge this gap. Divided into four stages-project premise, prototyping, GAMP 5 V-Model development, and software transference-this approach accelerates development, ensures compliance, and facilitates the transfer of R&D results to the pharmaceutical industry.

Source: Studies in health technology and informatics

DOI: 10.3233/shti250649

Authors: Ángel Sánchez-García, Marta Durá, Carlos Sáez, Juan M. García-Gómez

Institution: Universitat Politècnica de València

Language: English

Topic: Software Engineering Techniques and Practices

Subfield: Information Systems

Field: Computer Science

Domain: Physical Sciences

SDG: Industry, innovation and infrastructure

Open Access status: hybrid

OpenAlex ID: W4410447369

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