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
This paper is based on the samples of listed manufacturing companies of China, taking the financial performance as criterion, and then does research on the firm performance with different internal auditing modes, usin...This paper is based on the samples of listed manufacturing companies of China, taking the financial performance as criterion, and then does research on the firm performance with different internal auditing modes, using Cross-sectional data to analyze the distribution of internal auditing modes and the characteristics of the firm performance. The conclusion is that setting up internal auditing is good for the development of companies, but the function of internal auditing has not been widelv fulfilled.展开更多
In the mobile Internet era,the business model of new retail enterprises has changed greatly,so the audit mode needs to be innovated to adapt to the development of the times and improve the audit quality.Luckin Coffee ...In the mobile Internet era,the business model of new retail enterprises has changed greatly,so the audit mode needs to be innovated to adapt to the development of the times and improve the audit quality.Luckin Coffee has achieved rapid expansion relying on Internet technology,but the unsustainability of its business model leads to financial fraud by its management.In the mobile Internet era,the new retail enterprises,such as Luckin Coffee,are more suitable to adopt the data-based audit mode.In the audit process,the business model,original sales data,information system and transaction cycle are the key audit contents,and the key audit technologies such as field investigation,information technology and data analysis are adopted to realize the verification of financial information of new retail enterprises[1].展开更多
The assessment mode of the CPA audit independence risk based on the Rough Set Theory is a risk assessment method and using the Analytical Hierarchy Process, whose aim is to solve the bid management in the process of t...The assessment mode of the CPA audit independence risk based on the Rough Set Theory is a risk assessment method and using the Analytical Hierarchy Process, whose aim is to solve the bid management in the process of the Financial Statement Insurance. Firstly, according to the general instance of the accountant office, the experts grade the risk elements to establish the decision-making table; secondly, construct the judgment matrix using the attribution dependence degree of Variable Precision Rough Set to obtain relative importance, and further get the general importance for all of risk elements; Finally, establish the general assessment mode of the audit independence risk.展开更多
文摘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.
基金This paper is supported by National Natural Science Foundation of China （NoL70372028）, the ＂Projects 985＂ and ＂Projects 211＂ of Nankai University. It＇s the authors＇ responsibility to stand the errors in this paper..
文摘This paper is based on the samples of listed manufacturing companies of China, taking the financial performance as criterion, and then does research on the firm performance with different internal auditing modes, using Cross-sectional data to analyze the distribution of internal auditing modes and the characteristics of the firm performance. The conclusion is that setting up internal auditing is good for the development of companies, but the function of internal auditing has not been widelv fulfilled.
文摘In the mobile Internet era,the business model of new retail enterprises has changed greatly,so the audit mode needs to be innovated to adapt to the development of the times and improve the audit quality.Luckin Coffee has achieved rapid expansion relying on Internet technology,but the unsustainability of its business model leads to financial fraud by its management.In the mobile Internet era,the new retail enterprises,such as Luckin Coffee,are more suitable to adopt the data-based audit mode.In the audit process,the business model,original sales data,information system and transaction cycle are the key audit contents,and the key audit technologies such as field investigation,information technology and data analysis are adopted to realize the verification of financial information of new retail enterprises[1].
文摘The assessment mode of the CPA audit independence risk based on the Rough Set Theory is a risk assessment method and using the Analytical Hierarchy Process, whose aim is to solve the bid management in the process of the Financial Statement Insurance. Firstly, according to the general instance of the accountant office, the experts grade the risk elements to establish the decision-making table; secondly, construct the judgment matrix using the attribution dependence degree of Variable Precision Rough Set to obtain relative importance, and further get the general importance for all of risk elements; Finally, establish the general assessment mode of the audit independence risk.
