The deployment of a validated, low-code electronic Device History Record system on a high-mix, low-volume manufacturing line at Smith & Nephew’s Memphis site provides a practical and replicable model for regulated manufacturing environments that need to strengthen compliance while gaining flexibility for future analytics and system integration.
Abstract
This article describes the deployment of a validated, low-code electronic Device History Record (eDHR) system on a high-mix, low-volume manufacturing line at Smith & Nephew’s Memphis site. Prior to this work, all Device History Records were maintained on paper, creating delays in inspection, opportunities for transcription errors, and long retrieval times during audits. The new system runs on an industrial IoT platform and connects wireless gauges, barcode-based calibration checks, dynamic sampling logic, and modular inspection applications. Each module was validated independently and assigned to specific workstations so changes could be controlled without large documentation overhead. In day-to-day use, inspectors capture measurements directly from calibrated tools, materials are verified at scan, and each routing step is logged with a timestamp and operator ID. The transition from paper packets to a digital workflow reduced inspection time, lowered documentation defects, and improved audit preparation through immediate access to traceable records. The framework described here has since expanded beyond the original pilot to additional sites and value streams within Smith & Nephew, with further integrations and AI-enabled capabilities in active development. The resulting deployment provides a practical and replicable model for regulated manufacturing environments that need to strengthen compliance while gaining flexibility for future analytics and system integration.
The results indicate that language-model assistance can add value in regulated automotive requirements workflows when it is embedded in deterministic, provenance-rich, and expert-governed processes.
Test automation in regulated financial contexts goes beyond operational efficiency; it constitutes a risk governance mechanism that must be embedded in quality architectures from system inception.
Ricardo Polanski Alves· Journal of Interdisciplinary...· 0 citations
This research targets the introduction of traceability in master production scheduling (MPS) and focuses on the two-wheeler assembly line. Some issues, such as demand fluctuations, production capacity constraints, expensive emergency shipments, and worker ineffectiveness, continue to be present during production planning. To combat these problems, a traceability system, which includes PLC, HMI, sensors, QR code printing, and SQL Server, integrated to provide real-time shift-based production data of K1 EBR ABS model for all the three shifts. The planned vs. the actual data along with rework and scrap data show significant shift-dependent outcomes (first shift achieved 40% good parts (4 ok, 4 rework and 2 scrap from 10 planned); second shift 64%; third shift 75%; with no scrap). Weekly production efficiency fluctuated between 10% and 70% with no patterns. The research shows that traceability allows for the identification of root causes of quality losses, as well as loss of quality and efficiency. The main contributions are an applied traceability model and evidence for shift-dependent quality variation in automotive assembly.
Jayanthi Prasad C. S., A. T, Janardhan G Shetty· International Journal of Bus...· 0 citations
This paper presents an airborne software development approach for manned and unmanned aerial vehicles aimed at reducing inconsistencies across system, model-based functional, and embedded software domains. In environments influenced by standards such as ARP-4754B and DO-178C, these inconsistencies typically stem from insufficient enforcement across domain boundaries rather than missing process definitions. Building on a previously proposed toolchain centered on a relational interface database, we identify recurring failure modes and propose a repository-centered implementation to address them, tailored to small, resource-constrained teams operating without heavyweight process overhead. Each domain is assigned a primary repository with cross-repository references and dedicated CI pipelines that generate, update, and validate the exchanged artifacts. Automated interface updates, differential change notifications, and consistency checks propagate changes with minimal manual effort and surface inconsistencies before the time-consuming code-generation and compilation steps. An initial implementation in an ongoing experimental project is described, with qualitative feedback from its early use.
Nils Schlautmann, V. Sinitsyn, Benjamin Engelhard et al.· 0 citations
Firmware forms the persistent software layer controlling embedded and Internet-of-Things (IoT) devices, industrial controllers, automotive systems, and cyber-physical infrastructure. Vulnerabilities in firmware enable remote compromise, supply-chain attacks, and long-lived implants that survive operating-system reinstallation. This review synthesises 118 works published from 2014 to 2026—comprising 78 primary research studies; 23 surveys and systematisations of knowledge; and 17 benchmarks, tools, and background references—covering the full firmware reverse engineering (FRE) pipeline: physical acquisition (including fault injection and side-channel extraction), format analysis and unpacking, static analysis (binary code similarity detection, protocol reverse engineering, and patch diffing), dynamic analysis and hardware emulation, fuzzing-based vulnerability discovery, and artificial intelligence (AI) and large language model (LLM)-assisted analysis. Three additional dimensions are surveyed: digital twin-assisted firmware security testing; secure boot, trusted execution environment (TEE), and over-the-air (OTA) update security; and firmware rootkit and implant detection. Coverage spans two axes—the firmware class (Linux-based IoT, microcontroller-unit bare-metal, RTOS, UEFI/BIOS, PLC/ICS, and automotive ECU) and analysis depth (surface scanning to exploit-validated vulnerability chains). We identify ten structural gaps, including the absence of unified evaluation benchmarks, fragmented peripheral modelling, the scalability–fidelity trade-off in re-hosting, and insufficient grounding of LLM tools in firmware-specific realities. We conclude with six research directions for trustworthy, scalable, and infrastructure-aware firmware analysis.
Aditya Katpara, S. Sankaran· Electronics· 0 citations
The rapid expansion of the life cycle for software deployment has required a move from traditional, manual security analysis to automated and integrated assurance frameworks. This study examines the effectiveness of integrating assurance, real-time threat detection, and automated certification gates right into the Continuous Integration and Continuous Deployment pipeline. The analysis is based on a synthetic dataset comprising values from 429 different builds, which is used to study the agreement between automated gating mechanisms and lower vulnerability escape rates. We used a standard tool chain consisting of Jenkins for orchestration, SonarQube for static analysis, and Splunk for log aggregation to emulate a high-velocity enterprise environment. The system seeks to reduce technical debt and potential security risks without impeding deployment velocity by enforcing stringent quality gates that prevent non-compliant artifacts from being promoted. The study highlights the quantitative effects of these controls on success build rates and on the exposure of hidden threats during staging. The results reveal that, despite an initial slowdown in delivery velocity, the incorporation of automated certification gates considerably reduces critical severity incident rates. Implications: The results indicate how to make system changes in response to data for those attempting to put DevSecOps into practice while maintaining the speed and integrity of their systems.
Sauhard Bhatt, Satyanarayana Gadiraju· 2026 6th International Confe...· 0 citations