Developing Scientific Software According to Pharmaceutical Regulatory Compliance: A GAMP-Based Methodology
Ángel Sánchez-García, Marta Durá, Carlos Sáez, Juan Miguel Garcia-Gomez · Studies in health technology and informatics · 2025
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.