Conversion Readiness and Gap Analysis in SAP S/4HANA Migrations in Regulated Life Sciences Environments

Sudeepta Rana

Sudeepta Rana MBA, Bachelor of Pharmacy, Senior Application Consultant, Tampa, USA https://orcid.org/0009-0001-2711-5890

Keywords: SAP S/4HANA, conversion readiness, gap analysis, brownfield migration, greenfield implementation, life sciences, GxP validation, ERP modernization, custom code, solution architecture

Abstract

The article examines conversion readiness and gap analysis in SAP S/4HANA migrations across regulated life sciences organizations. ERP conversion in this sector affects transactional design, master data, custom code, validation evidence, and compliance control within the same program. The aim is to formulate an analytical model that connects gap analysis, readiness evaluation, and solution architecture. The study uses comparative source analysis, source criticism, conceptual synthesis, typologization, and analytical generalization across ten recent academic, regulatory, and SAP technical sources. The analytical part defines three results: a readiness logic shaped by brownfield and greenfield migration choices; a regulated life sciences gap taxonomy; and a decision path that links identified gaps to architecture. The model supports earlier separation of conversion risks, validation obligations, and design choices before realization work begins. The argument advances conversion readiness as an architectural control discipline, grounded in regulated process use and evidence requirements.

References

1. Arias, E. M. M., & Kurtoglu, K. K. (2025). Framework for ERP readiness assessment for life science companies: Examining key dimensions. Uppsala University.
2. Assunção, W. K. G., Marchezan, L., Egyed, A., & Ramler, R. (2024). Contemporary software modernization: Perspectives and challenges to deal with legacy systems. arXiv. doi: 10.48550/arXiv.2407.04017
3. Butarbutar, Z. T., Handayani, P. W., Suryono, R. R., & Wibowo, W. S. (2023). Systematic literature review of critical success factors on enterprise resource planning post implementation. Cogent Business & Management, 10(3), Article 2264001. doi: 10.1080/23311975.2023.2264001
4. Food and Drug Administration. (2026). Computer software assurance for production and quality management system software: Guidance for industry and Food and Drug Administration staff.
5. International Society for Pharmaceutical Engineering. (2022). GAMP 5: A risk-based approach to compliant GxP computerized systems (2nd ed.). ISPE.
6. Pedro, F., Veiga, F., & Mascarenhas-Melo, F. (2023). Impact of GAMP 5, data integrity and QbD on quality assurance in the pharmaceutical industry: How obvious is it? Drug Discovery Today, 28(11), Article 103759. doi: 10.1016/j.drudis.2023.103759
7. SAP SE. (2025a). Custom code migration guide for SAP S/4HANA 2025. SAP Help Portal.
8. SAP SE. (2025b). Conversion guide for SAP S/4HANA 2025. SAP Help Portal.
9. SAP SE. (2025c). Conducting fit-to-standard analysis workshops. SAP Learning.
10. Wynn, M., Ilyas, J., Isleyen, O. F., Brüntrup, H., & Metin, B. (2024). Reassessing critical success factors for ERP implementation in the digital era. Digital Technologies Research and Applications, 3(2), 117-131. doi: 10.54963/dtra.v3i2.297