System Compliance Research Articles

СИСТЕМНИЙ АНАЛІЗ МЕТАЛУРГІЙНОГО ВИРОБНИЦТВА ЯК ПІДҐРУНТТЯ ФОРМУВАННЯ СИСТЕМИ КОМПЛАЄНС

The purpose of the study is to determine modern approaches to the strategy of applying the compliance system at metallurgical enterprises. From the standpoint of the theory of hypercomplex dynamic systems, the components of the metallurgical enterprise are considered. Hypercomplexity is provided by the variety of sub-sectors included in the research object. The system properties of metallurgical production are highlighted, in particular, hypercomplexity (S1), dynamism (S2) and structurality (S3). It is shown that one of the latest global scientific developments regarding the procedure for compliance with obligations in the financial and industrial spheres is the theoretical concept of Compliance. It is advisable to provide advisory functions to the Compliance system at the enterprise, when the final decision on the implementation of its recommendations is taken by the management of the enterprise at the appropriate level. It is shown that common to all theories of Compliance is finding a balance between such categories as "compliance" with established requirements and "risks" from inappropriate fulfillment of obligations. The ratio of financial risks and the probability of compliance with these risks of business entities is given. It is shown that Compliance should acquire the status of not only a controlling body, but also take into account the elements of psychology in the implementation of its activities.

Centralized System for Monitoring Systems in Computer Laboratory

The Centralized Monitoring and Control System (CMCS) is a Python-based framework designed to streamline re- mote administration through a centralized server (Mother Node) and client scripts. This system enables efficient management and monitoring of multiple remote clients, facilitating tasks such as compliance enforcement, system monitoring, and file transfer. Key features include persistent client connectivity, cross plat- form compatibility with CentOS 7 and Debian 9, compliance enforcement based on CIS benchmarks, Splunk integration for centralized log monitoring, and real-time system metric monitoring. The project encourages community contributions to enhance functionality, ensuring adaptability to diverse user requirements. Installation involves cloning the repository and configuring the server script, while client deployment includes editing IP and port settings for seamless connectivity. CMCS offers a comprehensive solution for administrators seeking to optimize remote administration workflows and enhance system security across distributed computing environments.

Implications of the Foreign Corrupt Practices Act for the Construction of Compliance Systems in Chinese Multinational Enterprises

Implications of the Foreign Corrupt Practices Act for the Construction of Compliance Systems in Chinese Multinational Enterprises

Effects of positive end-expiratory pressure on pulmonary perfusion distribution and intrapulmonary shunt during one-lung ventilation in pigs A randomized crossover study.

During one-lung ventilation (OLV), positive end-expiratory pressure (PEEP) can improve lung aeration, but might over-distend lung units and increase intrapulmonary shunt. We hypothesized that higher PEEP shifts pulmonary perfusion from the ventilated to the non-ventilated lung, resulting in a U-shaped relationship with intrapulmonary shunt during OLV. In nine anesthetized female pigs, a thoracotomy was performed and intravenous lipopolysaccharide infused to mimic the inflammatory response of thoracic surgery. Animals underwent OLV in supine position with PEEP of 0 cmH2O, 5 cmH2O, titrated to best respiratory system compliance, and 15 cmH2O (PEEP0, PEEP5, PEEPtitr, and PEEP15, respectively, 45 min each, Latin square sequence). Respiratory, hemodynamic, and gas exchange variables were measured. The distributions of perfusion and ventilation were determined by i.v. fluorescent microspheres and computed tomography, respectively. Compared to two lung ventilation, the driving pressure increased with OLV, irrespective of the PEEP level. During OLV, cardiac output was lower at PEEP15 (5.5 ± 1.5 l/min) than PEEP0 (7.6 ± 3 l/min) and PEEP5 (7.4 ± 2.9 l/min; P=0.004), while the intrapulmonary shunt was highest at PEEP0 (PEEP0: 48.1 ± 14.4 %; PEEP5: 42.4 ± 14.8 %; PEEPtitr: 37.8 ± 11.0 %; PEEP15: 39.0 ± 10.7 %; P=0.027). The relative perfusion of the ventilated lung did not differ among PEEP levels (PEEP0: 65.0 ± 10.6 %; PEEP5:68.7 ± 8.7 %; PEEPtitr: 68.2 ± 10.5 %; PEEP15: 58.4 ± 12.8%; P=0.096), but the centers of relative perfusion and ventilation in the ventilated lung shifted from ventral to dorsal, and from cranial to caudal zones with increasing PEEP. In this experimental model of thoracic surgery, higher PEEP during OLV did not shift the perfusion from the ventilated to the non-ventilated lung, thus not increasing intrapulmonary shunt. This study was registered and approved by the Landesdirektion Dresden, Germany (25-5131/496/33).

The impact of evaluation and accountability on academic careers

ABSTRACT This article examines the work experiences of academics in Spanish universities with respect to how individuals are affected by the complex requirements of neoliberal compliance and a culture of endogamy, often referred to as ‘academic inbreeding’. The need to evaluate and be accountable for most aspects of academic work is relatively new in Spain and presently poorly understood. Compliance systems are usually introduced to enhance the quality of work, hold academics accountable for what they do, and provide a merit-based system for careers. However, in Spain, there is doubt that these objectives are being achieved. In our study, nineteen academics were interviewed about these issues. The majority felt that the evaluation systems were not fit for purpose and because of endogamy, academic merit was not the sole measure of a successful academic career. These outcomes have significant implications for quality and standards in this higher education system and we will argue that both issues need to be dealt with in a broader conversation about quality and the purposes of a university education.

Power quality assessment and compliance of grid-connected PV systems in low voltage networks using microinverters

AbstractSolar PV has experienced unprecedented growth in the last decade, with the most significant additions being utility-scale solar PV. The role of grid inverters is very critical in feeding power from distributed sources into the grid. With the increasing growth of grid-tied solar PV systems (both rooftop and large-scale), the awareness of power quality issues has risen with new regulations and standards to ensure the stability of the power grid. The power quality of microinverters has been investigated under steady solar irradiation and PV power source and also under real outdoor conditions in compliance with the accepted solar PV integration requirements. The current total harmonic distortion (THD) measured for the studied microinverter under outdoor conditions far exceeded the current THD for the study under steady indoor conditions and was beyond the accepted standard. However, the voltage THD outputs for the two studied cases were in good agreement with the grid codes. The voltage and current THD for the 400 Wm−2 (60 Wp) and the 1000 Wm−2 (146 Wp) scenarios under the steady solar irradiation (solar PV power) were 2.24%, 13%, and 2.27, 6.93%, respectively. The voltage and current THDs for the outdoor study were 2.03% and 14.28% for Solarex (pc-Si module), 1.94%, and 27.43% for Juta (mc-Si modules), and 1.97% and 33.6% for Dunasolar (a-Si glass module). Results showed a strong correlation between the intermittence of solar radiation and the current THD. 67%, 54%, and 37% of the recorded power factor for Dunasolar, Juta, and Solarex modules, respectively, exceeded the limits prescribed by the standards.

Apneustic anesthesia ventilation improves pulmonary function in anesthetized bottlenose dolphins (Tursiops truncatus).

Use of mechanical ventilation during general anesthesia is a necessary practice in the anesthetization of small cetaceans as spontaneous ventilation fails to provide adequate gas exchange. Currently available methods of ventilation do not account for the intermittent breathing strategy of representative species within this infraorder of fully aquatic mammals and may have a significant effect on cardiac and respiratory physiology. To understand the impact of mechanical ventilation on cardiopulmonary function in one small species of cetacean, the bottlenose dolphin (Tursiops truncatus), we compared controlled mechanical ventilation (CMV) to a novel ventilation method known as apneustic anesthesia ventilation (AAV). AAV simulates the normal inspiratory breath-hold pattern of dolphins. Ten anesthetic procedures (dental procedure, n = 9; bronchoscopy, n = 2) were performed on nine dolphins (age range: 10-42 years; mean = 32 years; median = 37 years; female = 3, 40%; male = 6, 60%). In a cross-over study design, dolphins were instrumented and randomly assigned to AAV or CMV as the initial mode of ventilation, then switched to the alternate mode. Baseline cardiopulmonary data were collected and again after 30 min on each mode of ventilation. Cardiac index, stroke volume index, systemic vascular resistance, alveolar dead space, alveolar-arterial oxygen tension gradient, arterial oxygen content, oxygen delivery index, and dynamic respiratory system compliance index were calculated at each of the four time points. During AAV, dolphins had higher arterial oxygen tension, higher mean airway pressure, reduced alveolar dead space ventilation and lower alveolar-arterial oxygen difference. Cardiovascular performance was not statistically different between the two modes. Our study suggests AAV, which more closely resembles the conscious intermittent respiratory pattern phenotype of dolphins, improves ventilation and pulmonary function in the anesthetized dolphin. Future studies should evaluate the cardiopulmonary effects of neutral buoyancy and cardiopulmonary sparing drug protocols to reduce the need for hemodynamic support of current protocols.

The Role of the Athletic Trainer in Providing Care to Transgender and Gender-Diverse Patients: Considerations for Medical Affirmation-Part II.

Recently, with discriminatory legislation efforts and changing participation policies in organized sports, media attention surrounding transgender and gender-diverse (TGD) individuals has increased. These changes and the historical lack of competence and education regarding the transgender patient population have resulted in subpar patient care and a misunderstanding of the athletic trainer's (AT's) role within the health care and compliance systems. This literature review is the second part of a 2-paper series, and our objective was to educate ATs on the processes relevant to medical affirmation, including compliance considerations regarding medical eligibility, and to establish the AT's role. The gender affirmation framework includes social and legal components, which are discussed in part 1 of this literature, and the medical component is thoroughly discussed in part 2. All health care providers involved in the care of TGD individuals should work collaboratively on an interprofessional care team and have a general knowledge of the gender-affirmation process, including gender-affirming hormone therapy, surgical options, known risks and complications, and the general health needs of TGD patients. With this knowledge, ATs, as point-of-care providers and members of the interprofessional care team, are uniquely positioned to help reduce health and health care disparities. Furthermore, ATs can use their knowledge to facilitate medical compliance and eligibility in the evolving policies of sporting organizations.

Prediction and simulation of PEEP setting effects with machine learning models

ObjectiveTo establish a new machine learning-based method to adjust positive end-expiratory pressure (PEEP) using only already routinely measured data. DesignRetrospective observational study. SettingIntensive care unit (ICU). Patients or participants51811 mechanically ventilated patients in multiple ICUs in the USA (data from MIMIC-III and eICU databases). InterventionsNo interventions. Main variables of interestSuccess parameters of ventilation (arterial partial pressures of oxygen and carbon dioxide and respiratory system compliance) ResultsThe multi-tasking neural network model performed significantly best for all target tasks in the primary test set. The model predicts arterial partial pressures of oxygen and carbon dioxide and respiratory system compliance about 45 min into the future with mean absolute percentage errors of about 21.7%, 10.0% and 15.8%, respectively. The proposed use of the model was demonstrated in case scenarios, where we simulated possible effects of PEEP adjustments for individual cases. ConclusionsOur study implies that machine learning approach to PEEP titration is a promising new method which comes with no extra cost once the infrastructure is in place. Availability of databases with most recent ICU patient data is crucial for the refinement of prediction performance.

Roadmap to achieve operational excellence through Lean Management implementation and quality management system conformance

Automotive companies are facing major challenges, namely competitiveness and the evolution that characterizes the sector. To ensure their sustainability, companies operating in the automotive industry are concentrating their efforts on reducing waste sources throughout the supply chain by implementing a variety of Lean Management tools. The compliance of the quality management system with the requirements of the international automotive standard IATF 16949:2016 is also a top priority for automotive suppliers. IATF certification is required to operate in the automotive market and enables organizations to meet customer requirements and demonstrate the quality assurance of their systems. This paper analyzes the principles of the Lean Management organizational tools in correlation with the requirements of the IATF automotive standard and determines their synergistic impact on operational excellence. Based on the correlation analysis performed, an original roadmap that will serve as a guide for automotive companies has been developed. The findings show that in order to achieve operational excellence, it is necessary to implement the five Lean Management organizational tools in correlation with the operational requirements dictated in chapter 8 as well as the leadership requirements outlined in chapter 5 of the international automotive standard.

The Obligation of The State to Realize Sharia-Compliant Certainty in Islamic Banking Financing

Introduction: Islamic banking is growing significantly and rapidly. The state needs its presence not only related to providing the right to freedom of religion but also ensuring that its implementation is following the provisions of sharia. Islamic banks have received a lot of criticism due to the existence of prohibited elements specifically in financing. Therefore, a supervision system for sharia compliance is needed.Purposes of the Research: This paper analyzes the basis and form of state obligations and their manifestation in ensuring compliance with Sharia principles in Islamic banking financing contracts in Indonesia. Because the State Financial Services Authority as the party with the authority in supervision has not reached the conformity of Sharia principles in the agreement as a private aspect.Methods of the Research: The problem analysis methodology involves legal research with a philosophical approach. The Statute Approach is conducted by reviewing applicable legal regulations, while the Analytical Approach involves analyzing legal principles and understanding through the examination of legal materials using techniques such as grammatical, teleological, and systematic interpretation.Results of the Research: The state is responsible for ensuring Sharia compliance in Islamic banking financing stems from the basic principles of Pancasila and the Constitution, as reflected in various laws, regulations, and fatwas of the National Sharia Council. These regulations serve as guidelines for sharia-compliant financing. However, legal certainty is needed in supervision and sanctions in implementing Sharia compliance.

Measurement System for Compliance in Tubular Structures

Tubular structures such as blood vessels, intestines, and the trachea are common in various life forms. This paper describes a measurement system to test the mechanical compliance of tubular structures. The novelty of the system lies in its hardware and software. Here we use vascular graft as an example to demonstrate the utility of the system. A fully synthetic vascular graft would ideally mimic the mechanical and architectural properties of a native blood vessel. Therefore, mechanical testing of the graft material under physiological pressure is crucial to characterizing its potential in vivo performance. The device operates through a low-cost Arduino-based control system that simulates and measures cyclic fluid pressure changes over time and a laser micrometer that measures diameter changes with pressure. This system is low-cost, assuming one already has access to a laser micrometer. In contrast to previous methods, this system offers a simple, low-cost, and customizable option to measure compliance and is equipped with data acquisition/analysis programs. These programs include a MATLAB application that processes and synchronizes Arduino Uno pressure signals and LabChart Pro diameter readings. Lastly, this paper explains the hardware and software of the measurement system. The system is beneficial for testing the pressure-diameter relationship of tubular structures of varying sizes and materials. KEYWORDS: Tubular Structures; Compliance; Data Acquisition System; Physiological Pressure; Diameter Change; Arduino Uno; LabChart Pro; MATLAB

The Respiratory Mechanics of COVID-19 Acute Respiratory Distress Syndrome-Lessons Learned?

Acute respiratory distress syndrome (ARDS) is a well-defined clinical entity characterized by the acute onset of diffuse pulmonary injury and hypoxemia not explained by fluid overload. The COVID-19 pandemic brought about an unprecedented volume of patients with ARDS and challenged our understanding and clinical approach to treatment of this clinical syndrome. Unique to COVID-19 ARDS is the disruption and dysregulation of the pulmonary vascular compartment caused by the SARS-CoV-2 virus, which is a significant cause of hypoxemia in these patients. As a result, gas exchange does not necessarily correlate with respiratory system compliance and mechanics in COVID-19 ARDS as it does with other etiologies. The purpose of this review is to relate the mechanics of COVID-19 ARDS to its underlying pathophysiologic mechanisms and outline the lessons we have learned in the management of this clinic syndrome.

Design and Development of A Web-Based Smart Recycling System based on a Survey on Recycling Awareness

Everyone is aware that recycling reduces the amount of waste that ends up in landfills, but the biggest environmental advantage of recycling is the preservation of energy and natural resources, as well as the reduction of pollution that results from the use of raw materials to create new products. The energy wasted in the disposal of products like aluminium cans and newspapers that can be recycled is equal to the annual output of fifteen power plants. The goal of this study is to determine how much faculty and students at UTHM are aware of recycling. Out of the roughly 18,000 pupils enrolled at the institution, 450 locals were chosen as the study's sample. According to Mitchell and Jolly, the populations require a minimum sample size of 374 samples, a 95% confidence level, and a 5% margin of error. There were tick boxes, a Likert scale, and slots for other suggestions to indicate responses. Residents are eager to engage in recycling activities, according to poll results, if more recycling facilities and technologies, such reward and redemption systems, are made available to them. Therefore, a strong program like the Web Automated Bin Recycle (WARB) System is necessary to address these problems. The carbon emission avoidance (tCO2e) calculator, which is part of WARB's core module, is used to calculate the total amount of CO2e generated by the weight of each material since each material has a unique CO2e reading. User acceptance testing (UAT) and functionality testing are the two types of evaluation tests used to assess WARB. The software system's compliance with their functional requirements or specifications has been successfully validated. The UAT results show that most users are content with the functionality and aesthetics of the system interface.

Economic and legal aspects of consumer rights protection

The article is devoted to the study of the construction "protection of consumer rights as a component of the economic legal order". The sustainable development of our country can be solved in the context of ensuring the rights of consumers, since the development of the economy is not possible without the reliable functioning of the consumer market. Only a protected and confident consumer is able to create conditions for the sustainable development of the enterprise even in adverse conditions of large-scale military aggression. It is the consumer at the microeconomic level who decides on the direction of his money, thereby exerting a kind of economic influence on business entities. Therefore, the protection of consumer rights cannot be reduced only to the restoration of already violated rights, since this does not allow to prevent their repetition.
 It was concluded that the prevention of violations of consumer rights requires the state to implement a preventive approach to prevent and prevent such violations, which is possible within the limits of ensuring compliance with the economic legal order. For this, the state must ensure compliance with the requirements of legitimate economic activity, in particular, the rules on fair competition and prevent the abuse of a monopoly position and other types of distortion of competition, as well as manifestations of unfair competition in areas of economic activity related to the consumer sphere. These tasks can be solved only under the condition of the introduction of the appropriate state economic policy. In order to ensure the interests and rights of consumers, there should be a consolidated influence of state bodies, local self-government bodies, as well as self-regulatory organizations of business and consumers, which will ensure compliance with high standards of conducting business activities that take place in organizational and economic relations. Also, ensuring the observance of consumer rights should be carried out in the organic interconnection of economic-production and intra-economic rela­tions, as this allows for the creation of a system of compliance with the quality standards of goods, works and services sold to consumers.

Predicting the effects of surgically determined parameters on exercise tolerance in Fontan patients

The Fontan physiology is a surgically created circulation for patients with a single functioning ventricle. Patients with this circulation tend to have lower exercise tolerance compared to those with a normal circulation. Important computational and experimental work has been done to investigate this reduction in exercise tolerance. However, there are few systematic modeling studies that focus on the effect of several surgically determined parameters within the same framework. We propose a mathematical model to describe the Fontan circulation under exercise. We then formulate a heuristic based on clinical data from Fontan patients to estimate exercise tolerance. The model is used to investigate the effect of three important surgically determined parameters on exercise tolerance: the systemic arterial compliance, the systemic-venous to pulmonary-venous fenestration, and the resistance of the total cavopulmonary connection.

Regulatory requirement for Medical Devices

The safety and regulatory compliance of a widely used medical device have become a growing concern among a significant population. This has raised questions about the assessment of risks, monitoring of adverse drug reactions (ADR), and overall product safety. The efficacy and safety of such medical devices heavily rely on the regulations and guidelines set forth by regulatory agencies (RAs).
 In the pharmaceutical industry, regulatory affairs (RA) professionals play a crucial role in overseeing the lifecycle of healthcare products. They provide strategic, tactical, and operational guidance to ensure compliance with regulations, facilitating the efficient development and delivery of safe and effective healthcare products worldwide. Evaluating adherence to regulations requires a combination of expertise from the business, legal, and pharmaceutical domains.
 Regulatory authorities must thoroughly monitor medical device design, development, and manufacturing processes to guarantee that the products reaching the market are safe and effective. The certification process is intricate, involving multiple steps and the assessment of materials by competent authorities. In the United States, manufacturers must seek marketing authorization from the United States Food and Drug Administration (USFDA) through two primary application types: 510(k) and Pre-Market Application (PMA). In the European Union (EU), national authorities grant permission for the sale of medical devices, employing a third-party compliance system where notified bodies ensure quality assurance pre- and post-approval. In India, the Central Drug Standard Control Organization (CDSCO) licenses devices for sale and import under the CLAA framework.
 Conclusion
 Pharmaceutical regulatory affairs experts play a critical role in ensuring compliance with industry requirements for all pharmaceutical products. This review provides an overview of how medical devices are regulated and monitored in the EU, India, and the USA, emphasizing the importance of regulatory affairs in maintaining the safety and efficacy of healthcare products.

Проблемы управления данными и решения в облачных средах.

The challenges of managing dynamic data that arise in cloud environments are discussed and new approaches to solving these problems are considered. Literature research was conducted, including case studies and opinions from industry experts. The study findings identified significant barriers to data management, including issues related to data security, data privacy compliance, data transfer challenges, and the risk of vendor lock-in. Various approaches have been proposed to solve problems - encryption methodologies, compliance systems, data transfer methods and multi-cloud environments. Implementing effective data management practices is paramount to harnessing the power of cloud computing while also maintaining data security and compliance measures.

Compliance Agreements: Emergent Flexibility in the Inter-American Human Rights System

Abstract Are agreements between states and victims an effective way to achieve reparations for human rights violations? We identify and evaluate a legal instrument hitherto ignored in analyses of the Inter-American Human Rights System: compliance agreements. These agreements emerged as a tool to negotiate the implementation of recommendations made by the Inter-American Commission on Human Rights to states responsible for human rights violations. In the first part of the paper, we theorize the role of agreements in securing state compliance, and discuss the problem of self-selection in legal settlements. We then document the emergence of this legal instrument and its novel role in the Inter-American System. In the third part, we provide statistical evidence from event history, matching, difference-in-differences, and sensitivity analyses showing that agreements increase the probability of compliance and cut the expected time to compliance by more than half. Agreements thus contribute to a potential solution for the perceived crisis of compliance in the Inter-American Human Rights System. However, the Commission must offer greater transparency to facilitate the evaluation of this mechanism.

Актуальные вопросы применения антимонопольного комплаенса в сфере недропользования

The market economy, which gives a certain freedom for entrepreneurial activity, at the same time dictates compliance with the established rules of competition, which are fraught with the risk of competition restrictions associated with antimonopoly violations, first of all, we are talking about the monopolization of the market, the creation of discriminatory conditions, etc. in the field of subsoil use. Antimonopoly risks mostly arise due to subjective reasons (human factor), less often under the influence of external factors (emergency situations). The adoption of preventive measures in the activities of companies is an effective measure in the control, regulation, and elimination of risks. Such an institution of preventive measures is the antimonopoly compliance system. The purpose of the study is to develop proposals for the application of antimonopoly compliance procedures in the field of subsoil use. The authors analyzed the regulatory legal acts in the field of antimonopoly legislation and the practice of their application, concluded that it is advisable to apply compliance procedures in the field of subsoil use.