Abstract

Enterprise Resource Planning (ERP) Applications control and manage complex business processes. The validation for such applications is very important due to the very high failure rate for ERP Applications. Any error made during the implementation of ERP leads to business failure. The objective of this study is to investigate the current ERP validation models and techniques to validate ERP systems in the pharmaceutical industry. This paper intends to serve two goals. First, it will be useful to researchers who are interested in the recent trends in ERP Validation. Second, it will identify the research gaps in the current ERP validation models with the aim of developing a new approach to validate ERP systems in the pharmaceutical industry. In the new approach, the focus will be on challenges in ERP applications validation, the impact of Critical Success Factors (CSFs) on ERP applications validation, the integration of risk assessment and ERP validation, the test rating and criticality during ERP validation, and the dependencies during ERP validation to improve the test evaluation.

References

• Prakash Reddy, “Business Central ERP (Optimizing Business Operations)”, 05 May 2025.
• Raja, Jawahar Rohith, Alekhya Kella, and Damodharan Narayanasamy. "The essential guide to computer system validation in the pharmaceutical industry." Cureus 16.8 (2024).‏
• Guide to Good Manufacturing Practice for Medicinal ProductsScheme, SFDA (2023).
• European Union and Council of Europe, "General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT", Aug 2018
• Bhagya Sarma Hari and Tarik El Taeib “Automating the Validation Process of Pharmaceutical Applications” Journal of Multidisciplinary Engineering Science and Technology (JMEST). April 2015.
• Singh, A., Singour, P., & Singh, P. (2018). Computer system validation in the perspective of the pharmaceutical industry. Journal of Drug Delivery and Therapeutics, 8(6-s), 359-365
• Abejo, Maria Corazon. "Enterprise Resource Planning (ERP) System Implementation Framework for Selected State Universities." International Journal of Computing Sciences Research 7 (2023): 2450-2477.‏
• Jaderi, Fereshteh, et al. "Criticality analysis using risk assessment-based maintenance of a petrochemical company." Pol. J. Environ. Stud 23 (2014): 2033-2037.‏
• Tyagi, Manika, and Sona Malhotra. "An approach for test case prioritization based on three factors." Int. J. Inf. Technol. Comput. Sci 4.4 (2015): 79-86.
• Miller, Tim. "Using dependency structures for prioritization of functional test suites." IEEE transactions on software engineering 39.2 (2012): 258-275.‏
• Wikipedia “https://en.wikipedia.org/wiki/Pharmaceutical_industry” Seen 22 Sep 2025.
• Singh, S., Singh, S., & Misra, S. C. (2022). Post-implementation challenges of ERP system in pharmaceutical companies. International Journal of Quality & Reliability Management, (ahead-of-print).
• Wanas, George Sharmokh. College of Computing & Information Technology Decreasing ERP Implementation Failure in Egypt. Diss. Arab Academy for Science, 2016.‏
• wikipedia “https://en.wikipedia.org/wiki/Enterprise_Resource_Planning” Seen 22 Sep 2025.
• Rusjan, Borut. "Computer system validation: Example of quality management system design and process implementation." Management: Journal of Contemporary Management Issues 25.2 (2020): 1-23.
• Hesham A and Patan IK “Computerized Systems Validation (CSV) in Biopharmaceutical Industries” Open Access Journal of Pharmaceutical Research (2020).
• Bhagya Sarma Hari and Tarik El Taeib “Automating the Validation Process of Pharmaceutical Applications” Journal of Multidisciplinary Engineering Science and Technology (JMEST). April 2015.
• Harmaceutical inspection convention pharmaceutical inspection co-operation scheme “pic/s guidance good practices for data management and integrity in regulated gmp/gdp environments” 1 july 2021.
• Chinta Sharvani, Vikas Jain, Hemanth Kumar, Gangadharappa H V "Implementation of Good Computer System Validation Practices in Pharmaceutical Industry - A Review", Dec 2021.
• Hesham A, and Patan IK "Computerized Systems Validation (CSV) in Biopharmaceutical Industries", 16 October 2020.
• Swarupa Vijay Jadhav, et al." Computer system validation in pharmaceutical industry ", 6 June 2021.
• Bujok, A. B. (2021). Development of a Software Testing Best Practice Framework for Medical Device Software (Doctoral dissertation, Dundalk Institute of Technology).‏
• Koumandaros, A. (2021). The prevention of data integrity failures in pharmaceutical manufacturing through risk-based validation of computerized systems _ (Doctoral dissertation, California State University, Dominguez Hills).‏
• Takahashi, Masakazu, and Reiji Nanba. "A Study of Computerized System Validation Method for PLC Based System.", Feb 2014.
• Rashid, dr md harun ar. "an overview: validation and its implication in pharmaceutical industry" international journal of inventions in pharmaceutical sciences, oct 2014.
• Koumandaros, Aris. The prevention of data integrity failures in pharmaceutical manufacturing through risk-based validation of computerized systems _. Diss. California State University, Dominguez Hills, 2021.‏
• Shubhrajit Mantry, L.Ramya, and S.Anil Kumar “AN OVERVIEW: PHARMACEUTICAL VALIDATION”, Sept 2014.
• Scheme, Pharmaceutical Inspection Co-operation. "Guide to good manufacturing practice for medicinal products annexes." (2022): 009-16.‏
• George Wanas, and Nagy Ramadan Darwish. "FMEA Approach for Decreasing ERP Implementation Failure using Critical Failure Factors.", Jun 2018.
• Bhagya Sarma Hari, and Tarik El Taeib “Automating the Validation Process of Pharmaceutical Applications” ISSN: 3159-0040 Vol. 2 Issue 4, April – 2015.
• Rusjan, Borut. “Computer system validation: Example of quality management system design and process implementation.” Management: Journal of Contemporary Management Issues 25.2 (2020): 1-23.‏
• EudraLex “https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en#latest-updates “Seen 22 Sep 2025.
• NIST “ https://www.nist.gov/ “, Seen 01 Oct 2025.
• ISACA “https://www.isaca.org/resources/news-and-trends/isaca-now-blog/2021/acronyms-only-scratch-the-surface-of-what-isaca-stands-for” Seen 22 Sep 2025.
• Koumandaros, Aris. The prevention of data integrity failures in pharmaceutical manufacturing through risk-based validation of computerized systems _. Diss. California State University, Dominguez Hills, 2021.‏
• Bujok, Andrzej Beniamin. Development of a Software Testing Best Practice Framework for Medical Device Software. Diss. Dundalk Institute of Technology, 2021.
• European Medicines Agency, et al. “Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems”, 16 Jan 2023.