Current - Issue
Year 2026 · Volume 5 · Issue 2
Original Article
Engineering a Digital Manufacturing Control Layer: An Integrated MES–EBR Architecture for GxP-Compliant Production
Sameel Syed1
1 Principal, Application Analyst, Herbalife International Americas INC, USA
Published Online: May-August 2026
Pages: 607-614
Cite this article
↗ https://www.doi.org/10.59256/indjcst.20260502069
References
1. U.S. Food and Drug Administration, “21 CFR Part 11: Electronic Records; Electronic Signatures,” FDA, 1997.
2. International Society for Pharmaceutical Engineering (ISPE), “GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems,” 2nd ed., 2020.
3. International Society of Automation (ISA), “ISA-95: Enterprise-Control System Integration,” 2010.
4. Körber Pharma, “MES for Pharma: Digitalizing Manufacturing Operations,” 2024.
5. Tulip Interfaces, “Electronic Batch Record App Suite: A Composable Approach to Pharma Manufacturing,” 2024.
6. ValGenesis, “The Role of Digital Validation in GxP Manufacturing,” 2024.
7. Oden Technologies, “Process AI in Manufacturing: Case Study on OEE Improvement,” 2024.
8. Rockwell Automation, “Manufacturing Execution Systems: ROI and Business Impact,” 2023.
9. Inductive Automation, “MES and SCADA Integration: Real-World Case Studies,” 2023.
10. Plex Systems, “The Financial Impact of MES Implementation: A Quantitative Analysis,” 2023.
11. TraceLink, “Serialization and Traceability in Life Sciences Manufacturing,” 2024.
12. SG Systems Global, “21 CFR Part 11 Readiness: What MES and QMS Must Prove,” 2024.
2. International Society for Pharmaceutical Engineering (ISPE), “GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems,” 2nd ed., 2020.
3. International Society of Automation (ISA), “ISA-95: Enterprise-Control System Integration,” 2010.
4. Körber Pharma, “MES for Pharma: Digitalizing Manufacturing Operations,” 2024.
5. Tulip Interfaces, “Electronic Batch Record App Suite: A Composable Approach to Pharma Manufacturing,” 2024.
6. ValGenesis, “The Role of Digital Validation in GxP Manufacturing,” 2024.
7. Oden Technologies, “Process AI in Manufacturing: Case Study on OEE Improvement,” 2024.
8. Rockwell Automation, “Manufacturing Execution Systems: ROI and Business Impact,” 2023.
9. Inductive Automation, “MES and SCADA Integration: Real-World Case Studies,” 2023.
10. Plex Systems, “The Financial Impact of MES Implementation: A Quantitative Analysis,” 2023.
11. TraceLink, “Serialization and Traceability in Life Sciences Manufacturing,” 2024.
12. SG Systems Global, “21 CFR Part 11 Readiness: What MES and QMS Must Prove,” 2024.
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