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The Effects of Competence and Auditor Training on Fraud Detection Within Multinational Companies in Sub-Saharan Africa
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作者 Ivan Djossa Tchokoté Joëlle Tsobze Tiomeguim 《Journal of Modern Accounting and Auditing》 2024年第1期1-13,共13页
The aim of this study is to examine the qualities that auditors engaged in detecting potential fraud within multinational corporations in Sub-Saharan Africa should possess.To achieve this goal,a quantitative approach ... The aim of this study is to examine the qualities that auditors engaged in detecting potential fraud within multinational corporations in Sub-Saharan Africa should possess.To achieve this goal,a quantitative approach was used to develop and test a research model based on three theories:agency theory,attribution theory,and cognitive dissonance theory.Responses from a panel of two hundred and nine(209)auditors who conducted a legal audit mission in a Sub-Saharan multinational were analyzed using SmartPLS 3.3.3 software.The results emphasize the crucial importance of auditors’competence and continuous training in fraud detection.However,professional skepticism and time pressure were found to be non-significant in this context.This conclusion provides essential insights for auditors,highlighting the key qualities needed to effectively address fraud detection within multinational corporations in Sub-Saharan Africa. 展开更多
关键词 FRAUD legal audit fraud detection MULTINATIONALS Sub-Saharan Africa
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Innovation of Audit Business Management Models under the Conditions of Information Technology
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作者 Kai Yuan 《Proceedings of Business and Economic Studies》 2024年第2期8-14,共7页
This paper focuses on the innovation of audit business management in the information technology era.In the wave of digitalization,audit companies need to adjust their management mode to take advantage of the advantage... This paper focuses on the innovation of audit business management in the information technology era.In the wave of digitalization,audit companies need to adjust their management mode to take advantage of the advantages of informatization.The key is to use digital tools to strengthen data analysis and reshape the audit process.This not only improves efficiency and accuracy but also improves the overall audit quality.The article also highlights the importance of developing a culture of continued auditor learning and skills development to ensure competitiveness in the digital age.At the end of the paper,the success of audit companies depends on innovation ability and the importance of combining management mode with technological innovation. 展开更多
关键词 audit INFORMATIZATION INNOVATION Digital tools Data analytics
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Analysis of the Impact of Big Data Technology on Environmental Pollution Control Audit
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作者 Xianrui Yang Jinyu Liu 《Proceedings of Business and Economic Studies》 2024年第3期22-27,共6页
As China strives towards the second centenary goal,increasing attention is being paid to environmental pollution and other related issues.Concurrently,with the rapid development of big data technology,many big data so... As China strives towards the second centenary goal,increasing attention is being paid to environmental pollution and other related issues.Concurrently,with the rapid development of big data technology,many big data solutions have been applied to environmental pollution control audits,exerting a significant impact.This paper presents the current situation of environmental pollution audits,summarizing the application of big data from the perspectives of both domestic and international research.In terms of data collection and data analysis for environmental pollution audits,cloud platform technology,and visualization technology are selected based on multiple data sources.The impact in the field of environmental pollution control audits is further analyzed.It is found that the environmental pollution audit cloud platform is not yet perfect,the technical skills of audit personnel are insufficient,and some technologies are not mature.Relevant suggestions are put forward to provide a reference for the future development of big data technology and its integration with environmental pollution control audits. 展开更多
关键词 Big data technology Environmental pollution control audit
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An Analysis of Innovative Contributions to the Important Discourse on the Development of New Quality Productivity
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作者 Yao Hao Jie Wu 《Journal of Contemporary Educational Research》 2024年第6期135-141,共7页
The discourse on developing high-quality productivity marks a significant theoretical innovation,which is conducive to the modernization and sinicization of Marxism.It refines our understanding of“new quality product... The discourse on developing high-quality productivity marks a significant theoretical innovation,which is conducive to the modernization and sinicization of Marxism.It refines our understanding of“new quality productivity,”defining it as an advanced form driven by innovation,embodying“high technology,efficiency,and quality,”with the aim of comprehensively enhancing productivity.It elucidates the necessity of cultivating such forces,asserting that they are crucial for achieving high-quality development,securing a leading position in global technology,and fulfilling the aspirations for a better life.Moreover,it outlines a new implementation route,emphasizing strategies such as fostering technological autonomy,nurturing emerging industries,integrating education and talent in technology,adopting a“build through challenges”approach,adjusting solutions locally,and providing categorized guidance,all of which are based on the ongoing comprehensive reforms. 展开更多
关键词 New quality productivity Basic connotation important discourse Realistic approach Innovative contributions
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A Federated Learning Framework with Blockchain-Based Auditable Participant Selection
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作者 Huang Zeng Mingtian Zhang +1 位作者 Tengfei Liu Anjia Yang 《Computers, Materials & Continua》 SCIE EI 2024年第6期5125-5142,共18页
Federated learning is an important distributed model training technique in Internet of Things(IoT),in which participant selection is a key component that plays a role in improving training efficiency and model accurac... Federated learning is an important distributed model training technique in Internet of Things(IoT),in which participant selection is a key component that plays a role in improving training efficiency and model accuracy.This module enables a central server to select a subset of participants to performmodel training based on data and device information.By doing so,selected participants are rewarded and actively perform model training,while participants that are detrimental to training efficiency and model accuracy are excluded.However,in practice,participants may suspect that the central server may have miscalculated and thus not made the selection honestly.This lack of trustworthiness problem,which can demotivate participants,has received little attention.Another problem that has received little attention is the leakage of participants’private information during the selection process.We will therefore propose a federated learning framework with auditable participant selection.It supports smart contracts in selecting a set of suitable participants based on their training loss without compromising the privacy.Considering the possibility of malicious campaigning and impersonation of participants,the framework employs commitment schemes and zero-knowledge proofs to counteract these malicious behaviors.Finally,we analyze the security of the framework and conduct a series of experiments to demonstrate that the framework can effectively improve the efficiency of federated learning. 展开更多
关键词 Federated learning internet of things participant selection blockchain auditability PRIVACY
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Identification of Important FPGA Modules Based on Complex Network
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作者 Senjie Zhang Jinbo Wang +3 位作者 Shan Zhou Jingpei Wang Zhenyong Zhang Ruixue Wang 《Computers, Materials & Continua》 SCIE EI 2024年第1期1027-1047,共21页
The globalization of hardware designs and supply chains,as well as the integration of third-party intellectual property(IP)cores,has led to an increased focus from malicious attackers on computing hardware.However,exi... The globalization of hardware designs and supply chains,as well as the integration of third-party intellectual property(IP)cores,has led to an increased focus from malicious attackers on computing hardware.However,existing defense or detection approaches often require additional circuitry to perform security verification,and are thus constrained by time and resource limitations.Considering the scale of actual engineering tasks and tight project schedules,it is usually difficult to implement designs for all modules in field programmable gate array(FPGA)circuits.Some studies have pointed out that the failure of key modules tends to cause greater damage to the network.Therefore,under limited conditions,priority protection designs need to be made on key modules to improve protection efficiency.We have conducted research on FPGA designs including single FPGA systems and multi-FPGA systems,to identify key modules in FPGA systems.For the single FPGA designs,considering the topological structure,network characteristics,and directionality of FPGA designs,we propose a node importance evaluationmethod based on the technique for order preference by similarity to an ideal solution(TOPSIS)method.Then,for the multi-FPGA designs,considering the influence of nodes in intra-layer and inter-layers,they are constructed into the interdependent network,and we propose a method based on connection strength to identify the important modules.Finally,we conduct empirical research using actual FPGA designs as examples.The results indicate that compared to other traditional indexes,node importance indexes proposed for different designs can better characterize the importance of nodes. 展开更多
关键词 Hardware security FPGA circuits node importance interdependent network
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What Is the Convenience of Treating a Wetland as an Agricultural Area?
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作者 Roberto De Pietro Renzo Ientile Giorgio Sabella 《Open Journal of Ecology》 2024年第6期544-561,共18页
The Gelsari and Lentini marshes, in east-central Sicily, are wetland under heavy anthropogenic pressure. This area is regularly subjected to water withdrawals and agriculture is practiced. Periodic bird census activit... The Gelsari and Lentini marshes, in east-central Sicily, are wetland under heavy anthropogenic pressure. This area is regularly subjected to water withdrawals and agriculture is practiced. Periodic bird census activities had been conducted in this area between 2016 and 2022 with collected data being supplemented with the data from a previous survey conducted between 2010 and 2016. During the censuses, numerous photographs were collected, which were later used for counts. In total, 121 surveys were carried out, with visits occurring approximately 20 times per year, covering all seasons. The data collected, both from bibliography and unpublished observations, were organised in table. 120 species and subspecies have been reported, 41 of which are in Annex I of the Birds Directive. Between 2021 and 2022, a water column measurement was taken in a central area of the Lentini marsh and compared with rainfall data in the area. It was found that water removal, occurring in both marshes in different modes, produced different effects on habitat conservation. Of the two marshes, Lentini is the one in which the existing favorable conditions in its most depressed areas, located below sea level, have allowed for the adequate conservation of the wetland. This environmental improvement having occurred with respect to the previous period has restored to the marsh its historically recognized possibility of not drying up completely during the summer period, allowing permanence of numerous birds. The obtained results suggest total elimination of agriculture and discontinuation of water withdrawals in the Lentini marsh as well as regulation of withdrawals in the Gelsari marsh. 展开更多
关键词 Sicily CHECKLIST CONSERVATION important Coastal Salt Marsh under the Sea Level Pantano Lentini
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Development of endemicity and conservation importance indices for tropical forests and the floral diversity assessment of Mt.Natoo in Benguet,Philippines
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作者 Johndale Rein T.BULLONG Jim P.SILVERIO +2 位作者 Joanna I.ALAFAG Maricel A.GURON Jones T.NAPALDET 《Journal of Mountain Science》 SCIE CSCD 2024年第3期786-804,共19页
The scientific community faces the challenge of measuring progress toward biodiversity targets and indices have been traditionally used.However,recent inventories in secondary tropical mountain forests using tradition... The scientific community faces the challenge of measuring progress toward biodiversity targets and indices have been traditionally used.However,recent inventories in secondary tropical mountain forests using traditional biodiversity indices have yielded results that are indistinct with primary ones.This shows the need to develop complementary indices that goes beyond species count but integrates the distribution and conservation status of the species.This study developed endemicity and conservation importance index for tropical forest that incorporated the distribution and conservation status of the species.These indices were applied to Mt.Natoo,a remnant primary mossy forest in Buguias,Benguet,Philippines,that resulted to endemicity index of 81.07 and conservation importance index of 42.90.Comparing these with secondary forest sites with comparable Shannon-Wiener,Simpson,Evenness and Margalef’s indices,our endemicity and conservation indices clearly differentiates primary forest(our study site)with higher values from secondary forests with much lower values.Thus,we are proposing these indices for a direct but scientifically-informed identification of specific sites for conservation and protection in tropical forests.Additionally,our study documented a total of 168 vascular plant species(79 endemic and 12 locally threatened species)in Mt.Nato-o.Majority are of tropical elements for both generic and species levels with some temperate elements that could be attributed to the site's high elevation and semi-temperate climate.These are important baseline information for conservation plans and monitoring of tropical mossy forests. 展开更多
关键词 Endemicity index Conservation importance index Cordillera Central Range Floristic element Jaccard Index of Similarity
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Does the Internal Audit Function Play a Role in Mitigating Earnings Management?
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作者 Hella Dellai 《Journal of Modern Accounting and Auditing》 2024年第1期20-38,共19页
This paper aims to investigate the effect of the characteristics of the internal audit function(IAF)on earnings management(EM)for a sample of 27 Tunisian listed companies.The authors employed the Correlated Panels Cor... This paper aims to investigate the effect of the characteristics of the internal audit function(IAF)on earnings management(EM)for a sample of 27 Tunisian listed companies.The authors employed the Correlated Panels Corrected Standard Errors model to estimate the regression equation.The results showed that EM is negatively associated with internal audit effectiveness,frequency of audit committee meetings with Chief Audit Executives(CAEs),the partial outsourcing of internal audit,and the firm’s size.Moreover,the authors found a positive relationship between EM and the use of IAF as a training ground for management and the private sector.This study is important to academics,regulators,and policymakers in introducing new governance reforms to strengthen the IAF as an important internal governance mechanism to reduce earnings management practices in emerging countries.The results also provide useful information for investors to examine the effect of internal audit characteristics on earnings management. 展开更多
关键词 earnings management internal audit emerging economies
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Overview of the Development of the Soybean Industry in the United States,Brazil and Argentina and Its Lessons for the Development of the Soybean Industry in China
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作者 Guancong Deng Tian Tian 《China's Foreign Trade》 2024年第1期47-50,共4页
Since the 1950s,China has gradually moved away from complete self-sufficiency in terms of soybeans to a high dependence on imports,and its annual import of soybeans accounts for about 60%of the global soybean trade.Br... Since the 1950s,China has gradually moved away from complete self-sufficiency in terms of soybeans to a high dependence on imports,and its annual import of soybeans accounts for about 60%of the global soybean trade.Brazil,the United States and Argentina have seen rapid growth in the soybean industry in just a few decades,and now account for about 80%of the world’s annual production.On the whole,in addition to the unique resource endowment and the continuous expansion of international market demand,the strong support of the U.S.government. 展开更多
关键词 SOYBEan ent IMPORTS
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The Importance of Breathing Training in Folk Dance Teaching
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作者 Xiaowei Sun 《Journal of Contemporary Educational Research》 2024年第4期187-192,共6页
The importance of breathing training in dance teaching is reflected in the two aspects of enhancing the quality of dance movements and sublimating the connotation of dance movements.For example,high-quality breathing ... The importance of breathing training in dance teaching is reflected in the two aspects of enhancing the quality of dance movements and sublimating the connotation of dance movements.For example,high-quality breathing can help performers complete the dance movements and improve the coordination of the movements;at the same time,the unique body rhythm formed by breathing can strengthen the visual effect of the performance and convey its spirit and soul to the audience.This requires folk dance teachers to carry out relevant training and teaching activities based on the categories and skills of dance breathing,such as changing students’ideological cognition,developing periodic breathing training courses,providing personalized guidance to students,and allowing students to adjust their learning and practice methods in the evaluation. 展开更多
关键词 Folk dance teaching Breathing training IMPORTanCE Training methods
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The Customer Requirements Analysis Method of Engineering Products Based on Multiple Preference Information
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作者 Guo Mao 《Proceedings of Business and Economic Studies》 2024年第1期204-209,共6页
To effectively evaluate the fuzziness of the market environment in product planning,a customer requirements analysis method based on multiple preference information is proposed.Firstly,decision-makers use a preferred ... To effectively evaluate the fuzziness of the market environment in product planning,a customer requirements analysis method based on multiple preference information is proposed.Firstly,decision-makers use a preferred information form to evaluate the importance of each customer requirement.Secondly,a transfer function is employed to unify various forms of preference information into a fuzzy complementary judgment matrix.The ranking vector is then calculated using row and normalization methods,and the initial importance of customer requirements is obtained by aggregating the weights of decision members.Finally,the correction coefficients of initial importance and each demand are synthesized,and the importance of customer requirements is determined through normalization.The development example of the PE jaw crusher demonstrates the effectiveness and feasibility of the proposed method. 展开更多
关键词 Product planning Customer requirements Importance ratings Multi-format information
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The Turkish Economy in the Period between 1990 and 2000 in the Light of the Open Economy Policies of the 1980s Developments
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作者 Sitki Selim Dolanay 《Economics World》 2024年第3期122-135,共14页
The structure of the economy seems to have been reshaped for the post-1980 period with the decisions of January 24,1980 and the structural changes that followed.In the 1980s,which can be called the transition process ... The structure of the economy seems to have been reshaped for the post-1980 period with the decisions of January 24,1980 and the structural changes that followed.In the 1980s,which can be called the transition process to a Free-Market Economy and an open economy,on the one hand,the privatization of state institutions and the determination of the prices of goods and services in free market conditions were tried to be ensured in order to withdraw the state from economic life,on the other hand,it was tried to grant freedom to foreign trade and capital movements.While these two main issues were being realized,the import substitution industrialization strategy was abandoned and the export-led growth model was started to be implemented.The last step of this process of opening up and liberalization was realized with the decision numbered 32 in 1989.While the change in the economic structure was achieved through domestic borrowing in the 1980s,with the liberalization of capital movements in the 1990s,it was seen that economic growth and development were tried to be achieved with hot money inflows rather than foreign direct investments.This orientation made the economy more open to crises,and for the first time there was a crisis in the form of the 1994 economic crisis,which was understood to be caused by hot money.The 1994 economic crisis could only be overcome by giving government guarantees to bank deposits and issuing high-interest Treasury Bills.Even the new banking regulations could not prevent the emergence of similar new economic crises in the following years.Because,we can say that the economic crisis experienced in the 2000s brought about a political transformation along with creating great economic problems. 展开更多
关键词 Turkish economy free market economy IMPORT export INVESTMENTS economic growth inflation
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The minimal clinically important difference for gait speed in significant unilateral vestibular hypofunction after vestibular rehabilitation
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作者 Isaac B.Thorman Brian J.Loyd +2 位作者 Richard A.Clendaniel Leland E.Dibble Michael C.Schubert 《Journal of Otology》 CSCD 2023年第1期15-20,共6页
Gait speed is a valid measure of both physical function and vestibular health.Vestibular rehabilitation is useful to improve gait speed for patients with vestibular hypofunction,yet there is little data to indicate ho... Gait speed is a valid measure of both physical function and vestibular health.Vestibular rehabilitation is useful to improve gait speed for patients with vestibular hypofunction,yet there is little data to indicate how changes in gait speed reflect changes in patient-reported health outcomes.We determined the minimal clinically important difference in the gait speed of patients with unilateral vestibular hypofunction,mostly due to deafferentation surgery,as anchored to the Dizziness Handicap Index and the Activities Balance Confidence scale,validated using regression analysis,change difference,receiveroperator characteristic curve,and average change methods.After six weeks of vestibular rehabilitation,a change in gait speed from 0.20 to 0.34 m/s with 95%confidence was required for the patients to perceive a significant reduction in perception of dizziness and improved balance confidence. 展开更多
关键词 Vestibular hypofunction Gait speed Minimal clinically important difference
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Assessment of the Implementation of Energy Conservation Opportunities Arising from Energy Audits;A Study of Four-Star and Five-Star Hotels in Nairobi Kenya
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作者 Nicholas Ogola Peter Musau Cyrus Wekesa 《Journal of Power and Energy Engineering》 2023年第9期15-44,共30页
This study assesses the implementation of energy conservation opportunities in four-star and five-star hotels in Nairobi. The Covid-19 pandemic had a significant impact on the Hospitality Industry. Currently, there is... This study assesses the implementation of energy conservation opportunities in four-star and five-star hotels in Nairobi. The Covid-19 pandemic had a significant impact on the Hospitality Industry. Currently, there is a growing inclination to furnish guests with superior and sustainable services in an energy-efficient and eco-friendly way. Comprehensive research was conducted from energy audits gathered from the establishments and contracted auditing companies, on top of this, hotel staff were given digital questionnaires. To add to the data, the researcher surveyed the hotels with engineering managers. The Energy Audits found that all 10 hotels had adopted Energy Conservation Opportunities (ECOs). After further analysis, the mean adoption rate of Energy Conservation Opportunities (ECOs) during the past three years was 55.83%, which was below the aim of 100%. According to studies, hotel staff manages energy to cut costs. The researcher found that hotels use up a lot of energy. However, they have conservation potential, depending on government policies, costs, ease of implementation, and management commitment to sustainable practices. Essentially, Energy Conservation Opportunities (ECOs) reduce energy expenditures and boost reliable revenues, especially during high energy prices and uncertainty. 展开更多
关键词 Energy Conservation Opportunities (ECOs) Energy Regulation 2012 Energy audit 4-Star Hotel 5-Star Hotel Energy Management Environmental Sustainability Energy Efficiency
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An Uneven Impact of Emerging Technologies on Taxpayers With Various Income Levels Audited by the IRS: Empirical Evidence From an AI Technology Application and Regression Models
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作者 Gordon Leeroy 《Journal of Modern Accounting and Auditing》 2023年第4期83-92,共10页
This study aims to investigate the influence of emerging technology adoption on tax compliance, encompassing both the Internal Revenue Service’s (IRS) compliance audits and taxpayers’ compliance performance (collect... This study aims to investigate the influence of emerging technology adoption on tax compliance, encompassing both the Internal Revenue Service’s (IRS) compliance audits and taxpayers’ compliance performance (collectively, tax compliance). We employed the Gradient Descent optimization algorithm, an artificial intelligence (AI) technology application, to scrutinize the connection between the quality of US tax filings and the development of emerging technology, among other contributing factors. Additionally, we utilized multiple linear regression to evaluate the relationships between dependent variables, specifically IRS audit rates and the no-change rate at different income levels,1 and several independent variables, including a proxy for emerging technology in the form of tax software. Our findings reveal that while emerging technology significantly impacts tax compliance within the IRS and taxpayers’ performance, its effects vary across income groups. Notably, emerging technology seems to confer greater advantages to higher-income individuals compared to their lower-income counterparts. These study results hold considerable policy implications for government decision-makers in promoting the adoption of emerging technology among lower-income taxpayers. 展开更多
关键词 IRS audit taxpayer compliance emerging technology artificial intelligence tax software income levels
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A Brief Discussion of Audit Risks and Their Causes
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作者 Zhihua Xie 《Proceedings of Business and Economic Studies》 2023年第6期98-103,共6页
As a crucial supervisory department overseeing economic operations,the audit department plays a pivotal role in safeguarding the healthy development of the country’s economy,exposing corruption,and effectively mainta... As a crucial supervisory department overseeing economic operations,the audit department plays a pivotal role in safeguarding the healthy development of the country’s economy,exposing corruption,and effectively maintaining social and economic peace and stability.The work of auditing involves detecting existing issues,providing remedies,and consistently contributing to national governance.However,as the market economic environment undergoes continuous changes,legal systems advance,and the audit environment becomes more complex,audit risks have gradually gained prominence.The prevention of audit risks has increasingly captured the attention of audit agencies at all levels.This necessitates audit institutions to continually adapt to new challenges,comprehend risks,and exert effective control over them.This article delves into the causes of audit risks,exploring ways to effectively identify and respond to these risks within a complex and ever-changing environment.The objective is to ensure the objectivity and accuracy of audit reports,allowing the audit function to truly serve as an“immune”system,protecting public interests. 展开更多
关键词 audit risk REASONS audit environment
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The Construction and Implementation Path of the Audit System for Quality Control in the Big Data Era
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作者 Wenjun Zou 《Proceedings of Business and Economic Studies》 2023年第6期111-115,共5页
In the era of big data,the construction and implementation of a quality control audit system are particularly crucial.This article delves into the impact of big data technology on quality control auditing,establishes ... In the era of big data,the construction and implementation of a quality control audit system are particularly crucial.This article delves into the impact of big data technology on quality control auditing,establishes a quality control auditing system in the big data era,and elucidates the pathway to realizing this system.Through the application of big data technology to quality control audits,there is an enhancement in audit efficiency,the attainment of more accurate risk assessment,and the provision of robust support for the sustainable development of enterprises. 展开更多
关键词 Big data Quality control audit system
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Internal Audit and Risk Analysis:The Particular Case of a Public Entity in Portugal
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作者 Maria da Conceição da Costa Marques 《Management Studies》 2021年第2期111-123,共13页
The purpose of this paper is to present the results obtained by an internal audit unit of a large public sector entity,in the area of education,during 2018,which we will call here Entity X and analyze the impact that ... The purpose of this paper is to present the results obtained by an internal audit unit of a large public sector entity,in the area of education,during 2018,which we will call here Entity X and analyze the impact that developed work had in the management decisions of that entity.The methodology used in the preparation of the article is the case study,where Cervo,Bervian,and Silva(2007,p.62)define it as“research on a particular individual,family,group or community that is representative of their universe,to investigate the different aspects of life”.The theoretical framework on the theme(secondary sources)was developed from bibliographic and documentary research,which concerns the classification of procedures and are appropriate to the characterization of this study,as an instrument for collecting information on the subject in question(Gil,2006).The results obtained are related to the activity of the referred internal audit unit in 2018,which proved to be quite fruitful and are developed in points 4,5,and 6 of the paper.During the preparation of the study,some limitations were found,related to the fact that it was only possible to analyze the year 2018,thus failing to establish a relationship with the department’s activity history.In our opinion,this study is important because it allows other similar entities to verify that it is possible to carry out internal auditing in the public sector(especially in this sector of education),since this practice is not yet disseminated within the area.This study is original in that it uses real data from an internal audit body. 展开更多
关键词 internal control audit ACCOUNTING management
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The Self-inspections(Internal Audits)Process as a Part of the Pharmaceutical Quality System:Formation of a Risk-Based Approach to Internal Audits Planning
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作者 Valeriy Nikityuk Tetiana Karamavrova V.Lebedynets 《Journal of Pharmacy and Pharmacology》 2019年第7期385-397,共13页
The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to it... The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system. 展开更多
关键词 Medicinal products PQS SELF-INSPECTION internal audit quality RISK management risk-based APPROACH
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