{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,17]],"date-time":"2025-05-17T04:04:37Z","timestamp":1747454677152,"version":"3.40.5"},"reference-count":0,"publisher":"IOS Press","isbn-type":[{"value":"9781643685960","type":"electronic"}],"license":[{"start":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T00:00:00Z","timestamp":1747267200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,15]]},"abstract":"<jats:p>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\u2014project premise, prototyping, GAMP 5 V-Model development, and software transference\u2014this approach accelerates development, ensures compliance, and facilitates the transfer of R&amp;D results to the pharmaceutical industry.<\/jats:p>","DOI":"10.3233\/shti250649","type":"book-chapter","created":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T09:02:58Z","timestamp":1747386178000},"source":"Crossref","is-referenced-by-count":0,"title":["Developing Scientific Software According to Pharmaceutical Regulatory Compliance: A GAMP-Based Methodology"],"prefix":"10.3233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1843-9209","authenticated-orcid":false,"given":"\u00c1ngel","family":"S\u00e1nchez-Garc\u00eda","sequence":"first","affiliation":[{"name":"Biomedical Data Science Laboratory, Instituto Universitario de Tecnolog\u00edas de la Informaci\u00f3n y Comunicaciones (ITACA), Universitat Polit\u00e8cnica de Val\u00e8ncia, 46022 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8269-9753","authenticated-orcid":false,"given":"Marta","family":"Dur\u00e1","sequence":"additional","affiliation":[{"name":"Biomedical Data Science Laboratory, Instituto Universitario de Tecnolog\u00edas de la Informaci\u00f3n y Comunicaciones (ITACA), Universitat Polit\u00e8cnica de Val\u00e8ncia, 46022 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2678-8249","authenticated-orcid":false,"given":"Carlos","family":"S\u00e1ez","sequence":"additional","affiliation":[{"name":"Biomedical Data Science Laboratory, Instituto Universitario de Tecnolog\u00edas de la Informaci\u00f3n y Comunicaciones (ITACA), Universitat Polit\u00e8cnica de Val\u00e8ncia, 46022 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3851-1557","authenticated-orcid":false,"given":"Juan M.","family":"Garc\u00eda-G\u00f3mez","sequence":"additional","affiliation":[{"name":"Biomedical Data Science Laboratory, Instituto Universitario de Tecnolog\u00edas de la Informaci\u00f3n y Comunicaciones (ITACA), Universitat Polit\u00e8cnica de Val\u00e8ncia, 46022 Valencia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","Intelligent Health Systems \u2013 From Technology to Data and Knowledge"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI250649","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T09:02:59Z","timestamp":1747386179000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI250649"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,15]]},"ISBN":["9781643685960"],"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti250649","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,15]]}}}