Lifecycle Management Research Articles

Information Modeling Implementation in PAO “Rosneft” as Challenge of Digitization in Construction Industry

Key goals of construction industry modernization and quality improvement are the introduction of information modeling which is an effective tool for increasing the enterprise competitiveness through the quality of design and construction, resource optimization and efficiency of interaction between process participants throughout the entire life cycle.The article presents information modeling (3D design) in PAO “Rosneft” with respect to the tasks of ensuring adaptation to design procedure in the company and the transition to full-scale 3D design. The choice of software is justified, real examples of completed pilot projects using information modeling are described, and information modeling implementation are presented. The experience in information modeling implementation helps companies to choose one or another software, and become familiar with the process at PAO “Rosneft”. As a result of the digital transformation of design processes, a model of the life cycle management system of capital construction project is developed, the basis of which is its information model. In addition, the main problems that require solutions for the successful information modeling implementation are identified, i.e., shortcomings of domestic software, shortage or absence of highly qualified personnel, unwillingness of customers to work with technical information, efficiency decrease of the organization due to the introduction of a new approach to project implementation into existing processes, resistance from employees, customers and contractors of construction, and installation works.The information modeling introduction in the PAO “Rosneft” allow to achieve goals for im[1]port substitution of technologies and prepare a worthy response to global geopolitical challenges.

Neural network classification of technological development projects in Russian companies: Perspectives of extreme project management

To achieve the goals of sustainable socio-economic development and ensure the technological sovereignty of the Russian Federation, it is critically important to choose effective methods of technological project management. The article develops a novel toolkit for neural network classification of technological development projects in Russian companies and justifies the use of extreme project management to such endeavors. The methodological framework resides in the concepts of project lifecycle management and data mining. The study employed the following research methods: textual analysis of project documentation using large language models, and intelligent project classification based on two-dimensional projection of multidimensional clusters using Orange Data Mining. The research draws upon regulatory documents in the field of Russia’s scientific and technological development and open databases on Russian companies’ projects. The work proposes a new neural network classification toolkit based on a large language model. We have found that most development projects related to critical and end-to-end technologies are characterized by low certainty of goals and solutions, which necessitates applying extreme approaches to manage them. The findings can be used by Russian companies for reasoning the choice of a project management model, as well as by experts when evaluating technological development projects.

Towards Better Financial Governance: The Urgency of Model Risk Management in Indonesia Viewed Through Maqashid Shariah

This study assesses the adequacy of Model Risk Management (MRM) frameworks within Indonesian Islamic banking by utilizing Maqashid Shariah principles as a tool to align these frameworks more closely with global standards, specifically focusing on safeguarding life (Hifzh Al-Nafs) and property (Hifzh Al-Mal). Through a comparative literature review, this research examines the structure and effectiveness of MRM practices in Indonesia, referencing regulations such as POJK 65/2016 and SEOJK 25-SEOJK.03-2023, against those in developed financial markets such as the USA, UK, Europe, Japan, and UAE, with an emphasis on governance, lifecycle management, and internal audit processes. The findings suggest that Indonesia’s current MRM frameworks are somewhat rudimentary when contrasted with international norms. Key areas identified for enhancement include expanding the scope, enhancing governance structures, refining model lifecycle management, and strengthening internal audits and oversight mechanisms. By employing Maqashid Shariah principles as an analytical tool, this paper proposes enhancements to MRM frameworks that can significantly improve the stability and compliance of Islamic banks in Indonesia, promoting greater global competitiveness and adherence to Shariah principles. This approach not only integrates traditional MRM approaches with Islamic ethical standards but also provides a tailored framework for regulatory enhancements that support a stable, compliant, and ethical Islamic banking environment.

A Study on Measuring the Impact of Business Process Management on an Organization’s Business Performance Superiority

The study's overarching goal is to quantify the effect of BPM on the improved business performance of participating organisations. The research used the corporate process management life cycle methodology to identify the concept of superiority. Along with describing the operational and competitive dimensions of business performance superiority, the opinions and responses of the 89 managers who made up the sample were utilised to describe (process identification and design, process modelling and documentation, process monitoring and controlling, and process optimisation). To validate the study's hypothesised model and draw attention to BPM's role in explaining why some organisations outperform others, researchers performed multiple regression analysis. Organisational managers must provide moral and financial support for business process orientation within the business entrepreneurship window in order for their organisations to maintain a competitive advantage in an uncertain, risky, and potentially volatile environment.

Implementation of Site Quality Management System for a Building Construction Project

Construction industry plays an important role in the development of any country. The development of construction industry depends on the quality of construction projects. Quality is one of the critical factors in the success of construction projects. Improvement in the quality of construction projects is linked with quality management in the project life cycle. Although quality management at every stage of project life cycle is important but the quality management at the execution (construction) stage contributes significantly on final quality outcome of construction projects. This project mainly focuses the importance and factors that affects the quality management in the execution (construction) phase. The project also includes visiting of some construction companies and conducts the questionnaire survey, then analyse the difficulties (major factors) and the cost variance due to quality defect in quality management and suggests some proactive measures for the improvement of quality in the execution phase of construction projects.

Fatigue life assessment of thermite welded rails based on laboratory tests and field measurement data

This in-depth study assesses the fatigue life of thermite-welded 60E1 rails by combining fatigue experimental tests with field measurement data. Material characterization, conducted using X-ray Diffraction (XRD), X-ray Fluorescence (XRF), and Scanning Electron Microscopy (SEM), aimed to understand the fatigue behavior of these materials. The research was particularly focused on high-speed rail lines in South Korea, targeting areas with influence of track condition to collect strain data. By combining dynamic modulus calculations from high-speed tensile tests with the rain flow counting method for determining wheel loads, and employing the Linear Cumulative Damage method for estimating rail fatigue life, this study provides novel insights into the maintenance and durability of thermite welded rails. The integration of detailed laboratory experiments with field stress data offers a significant contribution to the predictive maintenance and lifecycle management of high-speed railway infrastructure.

A micro‐level model for crisis management in tourism destinations: An interdisciplinary approach

AbstractCrisis management models aim to prevent, prepare and successfully overcome a crisis. The tourism industry is particularly prone to crises and thus requires adequate models to deal with crises and disasters. Several researchers developed crisis management models for tourism crises. As scholars call for a more holistic approach, this systematic literature review examines 25 crisis management models with organisational and tourism focus between 1979 and 2019 applicable to the tourism field. A textual narrative synthesis is used as methodological approach to analyse and understand the identified models, not only formally but also content‐wise. The findings show that crisis terminology is not consistent, that the crisis lifecycle and crisis management processes are used disparately and that stakeholder involvement within the models is low. As a result, a new model for destination crisis management is created on a micro‐level with aligned terms and phases.

Quality risk management and data integrity in R&D laboratories supporting CMC lifecycle of biological products

The development of pharmaceutical products is the critical bridge that moves a potential new medicine from academic discovery to applied treatment of patients. It translates an idea for a new drug to bench-level research on how it can be manufactured, formulated, characterized and controlled for use in non-clinical and early clinical trials.From pre-clinical R&D discovery work through the commercial launch, substantial R&D CMC data is generated to develop and optimize cGMP manufacturing and testing operations, while also supporting product comparability, elucidating product / impurity structures, assessing critical quality attributes, developing the drug delivery mode, and developing the product formulation for long-term stability. Significant R&D CMC work continues post-approval to support continuous improvement and market expansion of the commercial product. These activities are crucial elements of Product Lifecycle Management, and taken together, they comprise Pharmaceutical Quality or Chemistry, Manufacturing and Controls (CMC). The objective of this paper is to mitigate the regulatory ambiguity of R&D quality systems with practical, risk-based examples and recommendations when conducting supportive CMC studies for biological products.Making sound strategic CMC decisions under any circumstances assumes data from R&D studies are reliable, traceable, and complete. While there are specific regulatory guidelines on phase-appropriate cGMP activities, none exist for quality practices in R&D CMC laboratories conducting non-cGMP studies. Hindsight is not the time to discover that R&D studies lack key elements that would otherwise have allowed the data to be directly presented to regulators, if needed. There is a strong prospective business interest in protecting considerable investments made for CMC R&D studies. Therefore, establishment of a robust and stage-appropriate R&D laboratory quality system is essential for companies seeking to capitalize on prior knowledge, protect investments, and be prepared for accelerated approval pathways.

The cost of ‘cost reduction’: An integrative review of blended workgroups

Blended workgroups, comprising both standard and nonstandard employees, are increasingly used by organisations to reduce costs, however, evidence on their effectiveness has been mixed. This integrative review analyses 96 relevant empirical studies, and organises the findings along three themes: impacts at individual and organisational levels, theoretical perspectives explaining the mechanisms of workgroup dynamics, and contingency factors influencing benefits and costs. Our findings offer four key insights: the importance of composition, the need for a multi-perspective approach, the development of targeted management practices, and the significance of career lifecycle management, all of which have important managerial implications. We suggest five avenues for future research: integrating theoretical perspectives, addressing employee psychological well-being, considering contextual factors, examining temporal changes, and analysing the impact of gender dynamics.

Optimizing IT Asset Lifecycle: A Comparative Analysis of Hardware Asset Management in ServiceNow and BMC Helix

Abstract: This research paper presents a comprehensive comparison of the Hardware Asset Management applications offered by ServiceNow and BMC Helix. The study examines key features, asset discovery and tracking capabilities, lifecycle management, integration with other ITSM processes, and reporting tools of both solutions. By evaluating their strengths and weaknesses in managing hardware assets, this paper aims to provide insights for organizations seeking to optimize their IT asset management practices and improve overall operational efficiency.

Medical Device Database: Scoping Lifecycle Review

Objectives: This study examines the utilization and lifecycle management of medical device databases in multiple regions including the United States, Europe, Japan, and Canada, and evaluates their public health impact. The objective is to identify best practices, gaps, and challenges in the current systems to inform future improvements and standardization efforts on a global scale.Methods: A comprehensive comparative analysis was conducted on databases in these regions. The analysis focused on the structure, operation, and application of these databases in lifecycle management. Key factors include data collection, integration, utilization throughout the product lifecycle, data accessibility, user interfaces, integration with other healthcare data, regulatory compliance, and public health impacts. Data were collected through literature reviews, policy documents, and expert interviews to provide a robust understanding of each system.Results: Results show reveal significant variations in how regions utilize medical device databases to enhance device safety and efficacy. While all regions aim to improve device safety and public health outcomes, there are notable differences in data accessibility, usage, and management practices. Comprehensive coverage of the medical device lifecycle from pre-market approval to post-market surveillance varies significantly. Integration with regulatory processes and support for public health interventions through detailed tracking and reporting mechanisms also differ widely. Data accessibility and integration with national databases remain challenging. Inconsistent data formats, varying levels of data granularity, and differences in regulatory requirements hinder effective global monitoring and comparison. Despite these challenges, the study highlights the potential for medical device databases to significantly enhance healthcare quality and patient safety.Conclusions: National medical device databases are crucial for improving healthcare quality and safety. They serve as vital tools for identifying issues and informing policy-making. Korea should consider developing a comprehensive database focused on user health protection and safety enhancement, aligned with global standards.

Stochastic Modeling of Crack Growth and Maintenance Optimization for Metallic Components Subjected to Fatigue-Induced Failure

Abstract The degradation of metallic systems under cyclic loading is subject to significant uncertainty, which affects the reliability of residual lifetime predictions and subsequent decisions on optimum maintenance schedules. This paper focuses two main challenges in developing a reliable framework for the lifecycle management of fatigue-critical components: constructing a stochastic model that captures uncertainties in crack growth histories, and presenting a computationally efficient strategy for solving the stochastic optimization associated with maintenance scheduling. Polynomial chaos (PC) representation is proposed to propagate uncertainty in the fatigue-induced crack growth process, using a database from constant amplitude loading experiments. Additionally, an optimization strategy is implemented based on Gaussian process surrogate modeling to solve the stochastic optimization problem under maximum probability of failure constraints. The sensitivity of the optimum solution to different probability of failure thresholds is examined. The proposed framework offers a decision support tool for informed decision-making under uncertainty, aiming to mitigate fatigue failure.

TERRITORY'S INNOVATION ECOSYSTEM: TOOLS FOR MANAGING DEVELOPMENT IN THE DIGITAL ENVIRONMENT

Purpose of the study. The innovation ecosystem of the territory was set to be the format of adaptation of the regional innovation system to the digital environment. This management model is rapidly developing, based on the generalization of empirical experience and multidirectional theoretical research. However, the diversity of management concepts requires building a logical relationship in terms of their application to ensure the successful operation of the ecosystem. Therefore, the purpose of this article is to substantiate management approaches and tools that contribute to improving the performance of the territory's innovation ecosystem in the digital environment. Conclusions. It is proposed to use the model for assessing its maturity as an information basis for managing the development of the territory's innovation ecosystem. A comparative analysis of approaches to the assessment of ecosystem maturity has been carried out. The key aspects of assessment are defined, and the expediency of building a structured dynamic complex of assessment models is substantiated. Promising models of ecosystem management (hybrid orchestration, multi-orchestration, multi-tier orchestration) are identified, which allow for non-hierarchical coordination of relatively independent partners in the process of creating a common value. The landscape of trajectories of possible development of the innovation ecosystem of the territory is constructed, which defines a controlled transition between possible states depending on the ratio of maturity levels of each of the participants and the ecosystem as a whole. The importance of taking risks into account for the possibility of realizing the optimal development trajectory is emphasized. A methodological approach to ecosystem risk assessment is proposed, combining: 1) a map of risks of the territory's innovation ecosystem, structured by life cycle stages and management level (an individual participant and the ecosystem as a whole), 2) risk ranking based on the assessment of their impact on the performance indicators of the territory's innovation ecosystem.

Optimizing Identity Management: Key Strategies for Effective Governance and Administration

The significance of identity management has escalated in today's digital environment, where sensitive information is frequently at risk of breaches and unauthorized access. This research aims to investigate the best governance and administrative practices to enhance identity management systems, with a focus on security, privacy, and usability. By analyzing current industry standards, regulations, and technological advancements, the study intends to provide valuable insights for organizations seeking to improve their identity management capabilities. The research employs a mixed-methods approach, combining quantitative surveys and data analysis with qualitative interviews, to achieve a comprehensive understanding of current practices and challenges in identity governance and administration. Key components such as authentication, authorization, and access control are examined, with practical recommendations provided to enhance identity management strategies. The study emphasizes the importance of adopting role-based access control (RBAC), continuous monitoring and compliance, identity lifecycle management, and integrating identity governance with IT infrastructure. Additionally, it highlights the significance of effective password management, robust authentication measures, and the implementation of Single Sign-On (SSO) solutions to improve security and user experience. The research also underscores the critical role of data encryption and protection measures in safeguarding sensitive information and mitigating data breach risks. By adhering to best practices in identity management, organizations can strengthen their overall cybersecurity posture, ensure regulatory compliance, and build trust among stakeholders in an increasingly complex digital landscape.

Batteries for electric vehicles: Technical advancements, environmental challenges, and market perspectives

AbstractThe rapid evolution of electric vehicles (EVs) highlights the critical role of battery technology in promoting sustainable transportation. This review offers a comprehensive introduction to the diverse landscape of batteries for EVs. In particular, it examines the impressive array of available battery technologies, focusing on the predominance of lithium‐based batteries, such as lithium‐ion and lithium‐metal variants. Additionally, it explores battery technologies beyond lithium (“post‐lithium”), including aluminum, sodium, and magnesium batteries. The potential of solid‐state batteries is also discussed, along with the current status of various battery types in EV applications. The review further addresses end‐of‐life treatment strategies for EV batteries, including reuse, remanufacturing, and recycling, which are essential for mitigating the environmental impact of batteries and ensuring sustainable lifecycle management. Finally, market perspectives and potential future research directions for battery technologies in EVs are also discussed.

Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment.

Aberrant or dysfunctional cellular enzymes are responsible for a wide range of diseases including cancer, neurodegenerative conditions, and metabolic disorders. Deficiencies in enzyme level or biofunction may lead to intracellular accumulation of substrate to toxic levels and interfere with overall cellular function, ultimately leading to cell damage, disease, and death. Marketed therapeutic interventions for inherited monogenic enzyme deficiency disorders include enzyme replacement therapy and small molecule chaperones. Novel approaches of in vivo gene therapy and ex vivo cell therapy are under clinical evaluation and provide promising opportunities to expand the number of available disease-modifying treatments. To support the development of these different therapeutics, assays to quantify the functional activity of protein enzymes have gained importance in the diagnosis of disease, assessment of pharmacokinetics and pharmacodynamic response, and evaluation of drug efficacy. In this review, we discuss the technical aspects of enzyme activity assays in the bioanalytical context, including assay design and format as well as the unique challenges and considerations associated with assay development, validation, and life cycle management.

A Global Industry Survey on Post-Approval Change Management and Use of Reliance.

Post-approval changes (PACs) to the control and manufacturing processes of medicines and vaccines are routinely undertaken and critical to enable both innovation and secure sustained supply. In a world of global supply chains, the existence of divergent national PAC requirements (with additional countries introducing new requirements with potential differences) and other factors including document preparation and response timelines, can lead to long delays in approval (of up to 3-5years) increasing the risk of disruption and shortages.We undertook an Industry survey in 2023 to assess implementation of ICH Q12, PAC procedures (change categorisation and review timelines) and use of reliance mechanisms across different countries (9 selected ICH Members and 19 Observers). Although this survey revealed limited implementation of Q12 in ICH Member countries, when comparing the data collected with those of a previous survey performed in 2020, we observed a broader adoption of risk-based approaches to variation categorisation (in all countries). This, however, was not reflected in improved timelines for approval.With regards to ICH Q12 adoption, the uptake of Post-Approval Change Management Protocols (PACMPs) was unchanged (with only one country reporting in-use) and implementation gaps were evident for Established Conditions (EC) and the Product Life Cycle Management document (PLCM). The survey found greater awareness of ICH Q12 and its tools compared to 2020, potentially illustrating the positive impact of training efforts. This illustrates the challenges being faced to broaden its implementation and use globally.In the same Industry survey, we also assessed PAC processes across different international countries. Long unpredictable timelines were the major concern across the countries surveyed together with limited capacity of the regulators. Four different CMC changes were selected and categorized by the respondents according to current knowledge of national classifications and timelines in the selected countries and compared with a reference classification and timeline from the European Medicines Agency and the World Health Organisation. This highlighted the lack of harmonisation of many countries with EU/WHO requirements, especially within the ICH Observer group.Last, this survey showed that some use of unilateral forms of reliance to Reference Authorities for PACs is starting. This is a mechanism all countries can employ, regardless of convergence of requirements and expertise, to enhance capacity building and reduce duplication of reviews, streamline variations approval, whilst accelerating patient access to innovation and securing supply.

Full Life Cycle Research Based on the Contradiction of Engineering General Objective

In the management of the entire life cycle of an engineering project, the contradiction of the overall engineering objectives is a complex and important issue. The study of the engineering life cycle based on the contradiction of overall engineering objectives aims to comprehensively analyze each stage of the project life cycle, identify the points of conflict among various objectives, and propose corresponding solutions to optimize the overall engineering objectives. This research on the engineering life cycle based on the contradiction of overall engineering objectives is a complex and significant topic. Through in-depth research and practice, it can promote the continuous improvement and development of engineering life cycle management, providing strong support for the successful implementation of engineering projects.

A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management.

The pursuit of harnessing data for knowledge creation has been an enduring quest, with the advent of machine learning and artificial intelligence (AI) marking significant milestones in this journey. Machine Learning (ML), a subset of AI, emerged as the practice of employing mathematical models to enable computers to learn and improve autonomously based on their experiences. In the pharmaceutical and biopharmaceutical sectors, a significant portion of manufacturing data remains untapped or insufficient for practical use. Recognizing the potential advantages of leveraging available data for process design and optimization, manufacturers face the daunting challenge of data utilization. Diverse proprietary data formats and parallel data generation systems compound the complexity. The transition to Pharma 4.0 necessitates a paradigm shift in data capture for manufacturing and process operations. This paper highlights the pivotal role of artificial intelligence in converting process data into actionable knowledge to support critical functions throughout the whole process life cycle. Furthermore, it underscores the importance of maintaining compliance with data integrity guidelines, as mandated by regulatory bodies globally. Embracing AI-driven transformations is a crucial step toward shaping the future of the pharmaceutical industry, ensuring its competitiveness and resilience in an evolving landscape.

Towards the DTT configuration management platform architecture

Effective project management methods, tools and working practices shall be applied to facilitate the communication and collaboration among the different institutions involved in the Divertor Tokamak Test (DTT) project. This paper deals with the definition of the configuration management platform architecture enabling technical integration of the DTT system. The first step consists in the identification of main requirements the platform should satisfy, considering the multidisciplinary domains and the geographically dispersed working teams characterizing the nuclear fusion sector and the maturity level of the specific project. Main characteristics of the most advanced Product Lifecycle Management (PLM) tools are identified, their limits and benefits are evaluated, and the suitable PLM platform is selected, satisfying the DTT project needs. The definition of the architecture of the configuration management platform for the DTT project aims at implementing the DTT assembly model in a unique environment able to exchange models and data even developed outside the platform ensuring the congruence of the design, the traceability of design changes and the adoption of a proper Systems Engineering approach.