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- Research Article
- 10.3760/cma.j.cn112142-20251014-00422
- May 11, 2026
- [Zhonghua yan ke za zhi] Chinese journal of ophthalmology
- D Niu + 3 more
A disease-specific database is a data integration and information management system that serves clinical research on the etiology, diagnosis, treatment, and prognosis of a specific disease, and it has become a powerful tool to meet the evolving demands of contemporary ophthalmic clinical research. This review synthesizes recent domestic and international findings, offering a systematic summary and analysis of the construction of disease-specific databases, along with the classification, current applications, and developmental trends of ophthalmic disease-specific databases. Additionally, it highlights high-quality ophthalmic disease-specific databases from around the world, aiming to provide a reference for the advancement of such databases in ophthalmology.
- Research Article
- 10.1039/d6ra01992g
- May 5, 2026
- RSC advances
- Fekri Abdulraqeb Ahmed Ali + 13 more
Ozone finds widespread use in water and wastewater treatment, air purification, food preservation, and medical sanitation since it has a very high oxidative potential and it decays easily to produce oxygen without leaving any long-lasting residues. However, in practice, the use of ozone on a large scale and over long periods is often limited due to such practical considerations as high energy use, the possibility of the formation of unwanted oxidation by-products, problems of operational and occupational safety, and restrictions on regulatory standards. This review will provide a critical evaluation of the technologies of ozone generation and its use, with the aspects of environmental protection and process safety taken into consideration. It initially describes the basic physical and chemical properties of ozone, the most commonly used methods of its measurement, monitoring and safe handling. Then, the key methods of ozone generation, i.e., ultraviolet irradiation, dielectric barrier discharge, and electrochemical processes are analyzed and compared systematically in the light of their working principles, system design, energy efficiency, economic viability throughout the system operation, and regarding their safety issues. An assignment of practical application cases is then conducted in order to show performance constraints to realistic operating environments. Lastly, the review presents significant barriers to large-scale deployment, including scale-up, system integration and safety management, and points to future directions of coming up with ozone technologies that are safer, more energy-efficient, and more sustainable.
- Research Article
- 10.26618/kjap.v12i1.21501
- May 1, 2026
- Kolaborasi : Jurnal Administrasi Publik
- Cintantya Andhita Dara Kirana + 3 more
Regulations and policies of Law of the Republic of Indonesia Number 18 of 2008 and its derivatives on Waste Management have ushered in a more comprehensive and integrated waste management system in Palembang City from upstream to downstream which includes waste reduction and processing activities. However, there are problems in maintaining the environment sustainably. Sustainable environmental development needs to optimize waste management from upstream (reduce, reuse, recycle) to downstream. This study aims to evaluate the extent and quality of waste management awareness among early childhood education students in Palembang City, and to assess the role of school-based curricula and parental participation in shaping that awareness. Specifically, it asks: (1) To what degree do students in Palembang understand core waste management concepts (sorting, reduction, recycling, composting)? (2) How do institutional and parental factors mediate or constrain that understanding? (3) What does the Paulo Freire’s empowerment framework reveal about the transformative potential and limitations of current pedagogical practices? The research method used is a mix method, namely by combining quantitative and qualitative approaches. Data sources are from the results of interviews, observations and documentation studies. The results of the study revealed that waste management activities that have been taught by early childhood education teachers cannot all be understood by each student due to the age limitation to understand waste materials and their management, so it is necessary to invite parents to be involved in children's waste management activities and provide education related to practices that can be done at home.
- Research Article
- 10.65102/is2026307
- Apr 30, 2026
- Ingegneria Sismica
- He Sun
Digital development is changing the organization of music education, but there are still widespread problems in existing teaching such as resource dispersion, feedback lag and insufficient process support. Around this practical demand, this paper, supported by computer technology, studies the construction path of music education intelligent teaching system under the background of digital, and designs the system from two aspects of music education network course design and teaching resources comprehensive management. On the course side, an intelligent teaching process covering goal decomposition, task arrangement, audio collection, process evaluation and feedback correction was constructed. At the management end, an integrated management system is designed, which integrates resource storage, label modeling, authority control and intelligent matching. The experimental results show that the average evaluation of network course design experts reaches 4.71, the accuracy of resource recognition is 95.4%, and the average response time of the system is 8.7 s under the scale of 5000 resources. Research shows that the system can improve the organizational efficiency, resource invocation ability and personalized support level of music teaching, and provide technical reference for the continuous optimization of digital music education.
- Research Article
- 10.22214/ijraset.2026.80454
- Apr 30, 2026
- International Journal for Research in Applied Science and Engineering Technology
The effective maintenance of data related to the faculty is an essential requirement for modern academic institutions in relation to administrative activities, accreditation process, and performance evaluation. Existing approaches used for maintenance of faculty data are usually disintegrated, inaccurate and ineffective. This paper describes the development of the web-based Faculty Profile Management System that offers a central place for keeping, modifying and managing all academic data. The implemented functionality includes creating profiles of the staff, uploading documents and verifying them, role-based checking of the data, and generating of reports automatically. Developed on the technologies of ASP.NET Core and SQL Server, the system is implemented according to the three-tier architecture principle. Implementation results show significant improvement in accuracy and accessibility of data. Data verifications increase accuracy, and reports support managerial decision making. The proposed system greatly decreases administrative work load and makes the process of managing of academic data organized and efficient
- Research Article
- 10.1038/s41746-026-02648-9
- Apr 24, 2026
- NPJ digital medicine
- Yuetan Chu + 31 more
Acute respiratory distress syndrome (ARDS) remains a major challenge in critical care, with mortality exceeding 40%. Its diagnosis and management depend on multi-step procedures, invasive arterial blood gas analysis, and subjective CT interpretation, often leading to inconsistency, delayed intervention, and increased procedural burden. To address these limitations, we develop AutoARDS, an all-in-one foundation model that transforms routine chest CT into a quantitative platform, enabling integrated and reproducible assessment of diagnosis, progression, oxygenation, physiology, and prognosis within a single, non-invasive workflow, thereby supporting faster and more standardized critical-care decisions. Technically, AutoARDS proposes to employ a multi-task pretraining strategy with adversarial perturbation, distilling routine but unstructured clinical data into unified representations for fine-grained pathological learning. Trained on over 50,000 CT volumes and validated across six medical centers (6,153 individuals), AutoARDS (1) established a reproducible CT-derived biomarker linking morphological injury with disease severity, enabling standardized tracking of pulmonary progression; (2) accurately diagnosed acute respiratory failure and ARDS (AUCs = 0.97 and 0.87), facilitating early recognition and reducing diagnostic delay; (3) directly estimated the P/F ratio (PCC = 0.83), outperforming SpO2-based monitoring for noninvasive severity stratification and ventilation management; and (4) predicted 28-day outcomes (time-averaged AUC = 0.79), providing complementary risk assessment for clinical planning. Further analyses confirm generalizability to ARDS-associated right ventricular dysfunction (AUC = 0.76) and revealed a positive shift image-derived age residuals, reflecting disease-related imaging patterns that resemble pulmonary aging. By bridging visual information with quantitative physiology, AutoARDS exemplifies a scalable blueprint for transforming chest CT into an integrated, quantitative platform for precise and reproducible critical-care management.
- Research Article
- 10.1080/12269328.2026.2648516
- Apr 23, 2026
- Geosystem Engineering
- Mohammad Reza Dehestani Ardakani + 1 more
ABSTRACT The well is the most important physical asset of any operating company in the oil and gas industry. The operator is obligated to have a certified well integrity management system (WIMS) with core components that cover all wells under its responsibility. These core components include risk assessment, well schematics and barriers, and well classification and prioritization. The purpose of developing this management system is to define the requirements and activities necessary to implement a WIMS in the production phase. All these plans are aimed at optimal and profitable extraction from oil and gas reservoirs with the least possible damage to human life, the environment, and the financial issues of the operating company. Software has been developed for this system. The information is continuously recorded and stored in this software by the operators, and managers have access to this data online. The most important part is the wells section, which will be discussed in detail. This paper provides a comprehensive review of risk assessment, potential consequences during well production operations, a complete classification of fluid flow barriers and their schematics, well classification with site-specific indicators, and well prioritization for maintenance planning based on color-coding and specific problem types. In risk assessment, the potential consequence levels are categorized into different types of damage, along with the probability and degree of occurrence of events, and subsequently, an implementation plan is presented for operationalizing it, including hazard identification. Well barriers from schematics to well barrier elements and their performance standards are explained. Then, well classification is performed using color-coding in four colors: green, yellow, orange, and red, based on indicators such as barrier status, annulus fluid type, annulus pressure, and leakage rate. System performance monitoring, maintenance, and repair of parts and equipment are also examined. Finally, the implementation of this system on one of the Middle East hydrocarbon fields with approximately 400 wells is carried out, where the status of 3 wells is red due to safety valve problem and high pressure and gas leakage of annulus and prioritized for first repair, 34 wells are orange due to choke valve problem and high pressure and without gas leakage of annulus and are of high importance for repair, 46 wells are yellow and under continuous and precise monitoring, and 223 wells are green and under monitoring. All cases have been operationally documented.
- Research Article
- 10.3390/electricity7020038
- Apr 23, 2026
- Electricity
- Rabia Mricha + 2 more
Home Energy Management Systems (HEMS) are increasingly positioned at the center of residential flexibility, particularly as homes integrate photovoltaics, battery storage, electric vehicles, and responsive loads. This systematic review examines recent advances in optimization and multi-asset coordination for HEMS. Searches were conducted in Scopus, Web of Science, IEEE Xplore, and ScienceDirect for studies published between 2020 and 2025; after screening and eligibility assessment, 90 studies were included. The findings indicates that deterministic optimization remains well suited to structured scheduling problems, whereas metaheuristic, hybrid, and learning-based methods are better able to address nonlinearity, uncertainty, and real-time adaptation. Across the reviewed literature, multi-asset integration generally improves cost, peak demand, self-consumption, and, in some cases, user comfort and emissions. Yet the field remains dominated by simulation-based validation. Future progress of HEMS will depend on real-world validation, interoperable system design, explainable control, and stronger alignment with user behavior, communication constraints, and regulatory frameworks.
- Research Article
- 10.55041/isjem06672
- Apr 21, 2026
- International Scientific Journal of Engineering and Management
- Trino S T + 1 more
The digital transformation of human resource management has emerged as a strategic priority for organizations seeking to enhance workforce efficiency and organizational effectiveness. This study examines the impact of Human Resource Management System (HRMS) implementation and integration on organizational development within Vortex Engineering Private Limited, an engineering and manufacturing firm headquartered in Chennai, India. Employing a descriptive research design, primary data were collected from 150 employees across five departments using a structured questionnaire incorporating Likert-scale instruments. Statistical analysis included normality testing (Kolmogorov-Smirnov and Shapiro-Wilk), Kruskal-Wallis H-test, Chi-square analysis, one-way ANOVA, and Spearman rank correlation. Findings reveal that 88.7% of respondents are aware of the HRMS system, 90% affirm its multi-functional integration, and 88% report a positive influence on organizational development. Spearman correlation analysis indicates a statistically significant moderate positive relationship between HRMS efficiency and employee performance (rs = 0.505, p < 0.01). The Kruskal-Wallis test demonstrates that employee work experience significantly influences perceived HRMS efficiency, payroll management, and productivity (p < 0.05). These results collectively underscore the strategic role of HRMS in driving organizational development through improved HR operations, cross-functional coordination, and evidence-based decision-making.Keywords: HRMS; Human Resource Management System; Organizational Development; HR Technology; Employee Performance; Digital Transformation; Engineering Organizations
- Research Article
- 10.18196/ijief.v9i1.29155
- Apr 18, 2026
- International Journal of Islamic Economics and Finance (IJIEF)
- Muhammad Bascharul Asana + 2 more
Islamic Social Finance Institutions managing over USD 2.4 trillion globally face unprecedented challenges from increasing economic volatility, yet traditional systematic reviews cannot adequately capture the complex, interconnected nature of contemporary risk management research or reveal evolutionary patterns in scholarly focus. This study employs an innovative systematic literature network analysis approach, integrating systematic review methodology with bibliometric network analysis, to comprehensively evaluate how crisis-adaptive integrated risk management systems enhance financial sustainability and operational resilience of Islamic finance institutions. Following PRISMA 2020 guidelines, we systematically reviewed 22 high-quality studies representing 1,432 institutions across 23 countries from Scopus database spanning from 2010 until 2025 period and conducted keyword co-occurrence network analysis using VOSviewer software. Crisis-adaptive systems demonstrated superior performance with 42% improvement in crisis resilience, 95% CI: 31-53%, 26% enhancement in financial sustainability, 95% CI: 19-33%, and 51% gains in operational efficiency, 95% CI: 38-64%, compared to conventional approaches. The bibliometric analysis identified five interconnected research clusters with 94% concordance between systematic themes and keyword patterns, revealing research evolution from fragmented studies toward integrated frameworks. Studies positioned at thematic intersections showed significantly stronger effect sizes, demonstrating that interdisciplinary approaches integrating governance, technology, and crisis adaptation yield superior institutional resilience. Institution-specific analysis revealed differential adaptive capabilities: Islamic banks achieved strongest crisis resilience improvements, 47% vs. 38% for others, while zakat organizations demonstrated superior operational efficiency gains, 58% vs. 49% average. The findings provide evidence-based guidance for implementing adaptive risk management systems while identifying critical knowledge gaps for future research prioritization in Islamic finance crisis management.
- Research Article
- 10.53941/ubs.2026.100012
- Apr 14, 2026
- Urban and Building Science
- Fabio Daniel Chaves Almanza
Based on a sustainability approach, the synergy between the current most implemented standards for Energy Management Systems (EnMS) ISO 50001:2018 and Environmental Management Systems (EMS) ISO 14001:2015 is addressed in this work to propose a general cyclical methodology for improving organizational comprehensive performance and promoting the transition to renewable energy. Nowadays, organizations are required to establish robust and integrated management systems, responding to intensive competition and complex market dynamics. The combined implementation of these standards is a recent research field, due to the recent arrival of ISO 50001 in 2011. There are already some studies regarding the benefits, drivers, challenges, and barriers that companies face with this integration. Therefore, this paper unprecedentedly explores a divergence coupling approach to propose a methodology framed in the Plan-Do-Check-Act cycle, for the promotion of good energy-environmental practices, continuous improvement and sustainability. The main divergences of the standards appear in the planning and operation clauses and are mostly related to ISO 50001 requirements not included in ISO 14001. Thus, through extrapolation the divergences are harmonized to shape the “Plan” and “Do” stages of the methodology. The “Check” and “Act” stages consist of compliance with sustainability principles and feasible courses of action. This proposed approach improves the integrated energy and environmental performance, and increases economic benefits and sustainability in any organization, but especially in fossil fuel-based industry, as in the referenced case study at the Tula refinery. Moreover, the findings presented can be used by standardization bodies and policymakers in accelerating energy transition and sustainable development.
- Research Article
- 10.3390/pr14081238
- Apr 13, 2026
- Processes
- Jianhua Bai + 15 more
During offshore oilfield development, traditional injection–production processes commonly suffer from delayed regulation, low operational efficiency, and heavy reliance on manual intervention. Achieving real-time diagnosis of injection–production anomalies and dynamic optimization under complex geological conditions and harsh marine environments represents a core scientific challenge. This study presents the development and field deployment of an intelligent cable-controlled injection–production integrated management system. The work is positioned as an application- and system-oriented study, focusing on addressing practical challenges in offshore oilfield operations through the integration of established machine learning techniques into a cohesive operational platform. The system employs a cloud-native microservice architecture and integrates nine functional modules, enabling closed-loop management from data acquisition to intelligent decision making. Key methodological contributions include: (1) a weighted ensemble model combining Random Forest and SVM for blockage diagnosis, balancing global feature learning with boundary sample discrimination to achieve 92% diagnostic accuracy; (2) a Bayesian fusion framework that integrates static geological priors with dynamic sensitivity analysis for probabilistic quantification of injector–producer connectivity, achieving 85% identification accuracy with rigorous uncertainty propagation; and (3) a three-stage human–machine collaborative mechanism that substantially reduces anomaly response latency while ensuring field safety. Field application in Bohai oilfields demonstrates that the system shortens the injection–production response cycle by approximately 42%, reduces anomaly response time from over 72 h to less than 2 h (a 97% reduction), decreases water consumption per ton of oil by 27.6%, and increases injection–production uptime by 11.3 percentage points. This study provides an interpretable, extensible, and closed-loop technical solution for intelligent offshore oilfield development, with future directions including digital twin predictive simulation and reinforcement learning for real-time optimization.
- Research Article
- 10.1080/12294659.2026.2646351
- Apr 8, 2026
- International Review of Public Administration
- Jeongwoo Lee + 1 more
ABSTRACT This study applies text mining to South Korean news data to identify weak signals related to elderly drivers and analyze their policy implications. A total of 2264 news articles published between January 2024 and March 2025 were collected, and keyword-based weak signals were identified. Word network analysis interpreted relationships between weak signals and co-occurring terms. The results revealed five signal categories—acceleration/brake/activation, free, black box, sidewalk, and system—corresponding to driving errors, incentive-based policies, accident documentation, pedestrian safety, and administrative structures. The findings highlight the need for technical measures to prevent pedal misapplication, mobility-related support for those ceasing to drive, recording devices for accident analysis, protection infrastructure against sidewalk intrusion, and conditional licensing and integrated management systems for elderly drivers. Recognizing elderly driver-related accidents as a structural risk, this study provides insights for traffic safety and criminal justice policy using a weak signal detection approach grounded in public discourse.
- Research Article
- 10.1002/ps.70465
- Apr 1, 2026
- Pest management science
- Huanwen Chen + 7 more
The red-haired bark beetle (RHB), Hylurgus ligniperda (Fabricius), is a significant invasive pest responsible for widespread mortality in pine forests. Current control methods are largely ineffective and poorly integrated, failing to halt the spread of RHB. This study aimed to develop and validate an integrated management system that leverages the beetle's behavioral patterns and implements stratified management strategies based on the severity of infestation levels. We first enhanced trapping efficiency by optimizing key technologies, including trap design, deployment methods, and lure formulations. Building on this foundation, we developed a stratified management plan with the following key measures: in newly colonized stands, a strategy combining benzyl alcohol repellents and optimized lure attractants, along with flight-interception traps, significantly reduced spread, decreasing the proportion of dead trees from 12.5% to 2.6%. In outbreak stands, intensive measures such as stump removal and mass trapping reduced the RHB population density by 99.05%. Additionally, replanting alters stand volatiles, reducing their attractiveness to the beetles. The stratified management strategy, applied to both newly colonized and outbreak stands of RHB, proved highly effective in suppressing population growth and preventing further dispersal. This approach offers a key technical solution for restoring damaged coastal ecosystems and provides a valuable reference for managing similar invasive pests worldwide. © 2025 Society of Chemical Industry.
- Research Article
- 10.1016/j.est.2026.121364
- Apr 1, 2026
- Journal of Energy Storage
- Sadiqa Jafari + 1 more
A comprehensive review of energy and battery management system integration: Architectures, approaches, and research directions
- Research Article
- 10.32750/2026-0120
- Mar 31, 2026
- Європейський науковий журнал Економічних та Фінансових інновацій
- Iryna Fedotova + 3 more
The article examines marketing logistics as an integrated management system within transport enterprises, emphasizing its role in creating sustainable competitive advantages through the effective management of flows and delivery of services that preserve consumer value. In modern economic conditions, traditional isolated application of marketing and logistics tools often fails to ensure the achievement of strategic objectives, particularly under circumstances of high uncertainty, resource limitations, and disruptions in supply chains, such as those experienced during martial law. Marketing logistics emerges as an integrative mechanism that combines market-oriented approaches with process- and flow-oriented logistics, aligning demand generation with the enterprise’s operational capabilities. A critical review of domestic and international literature reveals a lack of unified conceptual understanding of marketing logistics. Foreign studies tend to interpret it from a logistics perspective, emphasizing operational efficiency and physical distribution, while domestic research increasingly views it as a comprehensive, integrative system that coordinates marketing and logistics decisions to achieve long-term competitive advantages. The article classifies approaches to marketing logistics into three groups: functional-distributional, integration-oriented, and value-oriented (synthetic), reflecting its evolution from a narrowly operational function to a strategic management concept. The study offers a conceptual generalization of marketing logistics as an integrated management system under conditions of high uncertainty. The study identifies key objectives and tactical tasks of marketing logistics, including ensuring full and timely satisfaction of consumer demand, optimizing logistics costs, maintaining service quality, enhancing resilience, and supporting sustainable development and digital transformation. The article further delineates the core functions of marketing logistics — analytical, planning, organizational, coordination, control, and value-oriented — demonstrating their integrative nature in harmonizing marketing and logistics processes. Comparative analysis highlights that marketing logistics not only delivers physical products but also generates additional value for the consumer by balancing service levels with operational efficiency. The findings underscore the relevance of marketing logistics as a holistic management tool for transport enterprises operating in dynamic and uncertain environments. Prospects for further research include the development of digital, data-driven, and adaptive approaches to enhance efficiency, resilience, and sustainability in marketing logistics processes.
- Research Article
- 10.32983/2222-4459-2026-2-355-362
- Mar 31, 2026
- Business Inform
- Hanna S Chernoivanova
The article focuses on studying the theoretical and practical foundations of crisis management in enterprises under conditions of instability caused by the aftermath of the pandemic, the impact of martial law in Ukraine, and globalization challenges. The relevance of the topic is substantiated by the high level of company losses and the need to develop efficient mechanisms to counteract crisis phenomena for stable economic growth. The aim of the work is to clarify the essence of the concept of «crisis management» and to systematize its key components to form an efficient enterprise management system in the context of modern uncertainty. The study analyzes existing scientific approaches to defining the term «crisis management». It has been shown that this is not a separate function or a set of short-term measures, but an integrated management system that combines financial, organizational, strategic, and psychological aspects. Based on a detailed analysis of the literature, a generalized definition of crisis management has been formulated as a set of measures aimed at diagnosing financial conditions, developing managerial decisions to prevent crises, and minimizing their consequences. The article systematizes the key elements of the crisis management system, including the object, subject, goal, functions, principles, regulatory framework, and implementation mechanisms. Two main approaches are distinguished: strategic (long-term planning and risk prevention) and operational (prompt response to an ongoing crisis). The conclusion is that efficient operation of a modern enterprise requires constant readiness for financial imbalances and the creation of a reliable analytical base. The practical significance of the results is that the clarified structure of management elements provides a solid foundation for developing efficient strategies to stabilize domestic enterprises under contemporary threats.
- Research Article
- 10.34739/dsd.2025.02.12
- Mar 26, 2026
- De Securitate et Defensione. O Bezpieczeństwie i Obronności
- Victor Korendovych + 1 more
Objective: To develop a conceptual model of the Digital Transformation Management Sys-tem (DTMS) integrating digitization processes with capability-based defense planning. The study analyzes Ukraine's defense digital transformation (2014–2025), documenting achievements and proposing requirements for a future integrated management system. The research addresses the problem of ‘patchwork automation’ that arises from bottom-up vol-unteer initiatives and analyzes the shift of modern conflict toward cognitive warfare, where strategic goals include establishing situational awareness and manipulating adversary deci-sion-making. Hypothesis: Effective defense digital transformation requires systematic inte-gration of management with the Joint Capabilities Integration and Development System (JCIDS). This integration, supported by enterprise architecture, creates an asymmetric ad-vantage through shortened decision cycles and data fusion for cognitive advantage. Meth-ods: A systems approach was applied to analyze the digital ecosystems deployed during the Russo-Ukrainian war, including DELTA, Kropyva platforms, and the ‘Army of Drones’ ini-tiative, assessed against NATO (NAF) and DoDAF standards. The DOTMLPFI-P model was used to identify functional gaps. Results: The DTMS architecture based on three pillars (People, Technology, Processes) and five functional blocks was substantiated. A federated governance model with an architectural repository was proposed. Conclusions: Success in modern multi-domain warfare depends on strategic alignment of digital innovations with operational needs. DTMS facilitates the transition to flexible network-centric architectures that support operational advantage in cognitive warfare.
- Research Article
- 10.33380/2305-2066-2026-15-2-2191
- Mar 20, 2026
- Drug development & registration
- M M Kamkha + 3 more
Introduction. In the context of digital transformation and global harmonization of regulatory requirements, the implementation of integrated quality management systems in clinical trials based on ICH E6(R3) has become increasingly relevant. Aim. To conduct a comparative analysis of ICH E6(R3) against international standards (ISO, GAMP 5, PMBOK/APM-BOK) and assess their adaptability within the Russian regulatory environment. Materials and methods. A systematic analysis was performed of the Russian regulatory framework – including Federal Law No. 61-FZ of April 12, 2010; Decision No. 79 of the Eurasian Economic Commission Council of November 3, 2016, approving the Good Clinical Practice Rules of the Eurasian Economic Union; and GOST R 52379-2005 "Good Clinical Practice" – as well as international guidelines (ICH, ISO, PMI, ISPE) and scientific publications from 2020 to 2025 indexed in Scopus and Web of Science. Results and discussion. It was established that ICH E6(R3) necessitates a shift from reactive oversight to proactive quality management through the integration of risk-based approaches, digital technologies, and interdisciplinary standards. Within the Russian context, gaps in regulatory provisions and insufficient integration of quality management systems were identified. Conclusion. To align with ICH E6(R3), Russian regulatory authorities and organizations must modernize internal processes, implement Risk-Based Quality Management (RBQM), and harmonize national requirements with international standards.
- Research Article
- 10.37491/unz.109.5
- Mar 20, 2026
- University Scientific Notes
- Valentyn Zolka + 3 more
The article analyses current issues related to the observance of human rights in the field of Ukraine’s state border protection. It emphasises that the activities of the State Border Guard Service of Ukraine are aimed at ensuring an appropriate level of legal protection for travellers, an integral component of European border management standards. The practical implementation of progressive European practices in state border protection in Ukraine is examined, including the modernisation of border infrastructure and the introduction of digital services into the operations of state border protection authorities. The judicial practice in the administrative and legal regulation of state border-crossing procedures is reviewed, with due regard for human rights. Problematic issues in the field of human rights observance in cases of detention and holding of foreigners and stateless persons for illegal crossing (or attempted illegal crossing) of the state border are highlighted. The relevance of implementing the «Custody Records» system to the State Border Service's activities is emphasised. It can, on the one hand, significantly reduce violations of individuals’ rights during the application of border procedures, and, on the other hand, strengthen the guarantees protecting State Border Service personnel from unfounded accusations and increase their accountability. The need for systematic legal training and advanced training of state border protection personnel and units is emphasised. The need to develop and adopt the Law of Ukraine «On Integrated State Border Management» and to create an interdepartmental coordination body under government control is substantiated as a strategically important step to ensure an effective state border protection system that meets European Union standards. The need to develop and adopt the Law of Ukraine «On Integrated Border Management» and to establish an interagency coordination body under government control is substantiated as a strategically important step to ensure an effective state border protection system that complies with European Union standards. It is proposed to adapt the institutional model of the Fundamental Rights Office/Fundamental Rights Monitors to the State Border Guard Service's activities to prevent human rights violations, enhance the transparency of border authority operations, and integrate European Union practices into Ukraine’s national integrated border management system. It is concluded that improving Ukraine’s legal framework for integrated border management, as a new institution within the state border protection mechanism, will ensure a balance between guaranteeing national security and complying with international human rights standards.