A GIS audit framework is necessary considering the diverse nature of GIS with regard to components, applications and industry. In practice, checklists are generated during the audit process based on specific objective...A GIS audit framework is necessary considering the diverse nature of GIS with regard to components, applications and industry. In practice, checklists are generated during the audit process based on specific objectives. There is no standardized list of items that can be used as a reference. The purpose of this study was to develop a GIS audit framework as a foundation for GIS audits. The framework provides that comprehensive approach to various GIS aspects during the audit process. The design builds on a developed conceptual framework where most significant categories of GIS audit parameters namely data quality, software utilization, GIS competency and procedures (work flows) were identified. The study adopted a reductive model approach to simplify the complexity associated with each category of GIS audit parameter. The resultant audit elements for each category are organized in a matrix that forms an integral part of the framework. The columns comprise audit goal, audit questions and audit subjects as indicators which are qualitatively measured. The rows comprise the parameters (data quality, software utilization, personnel competency and procedure (workflows)). To use the framework, an auditor only needs to create an audit checklist that consists of particular parameters and indicators from the framework depending on audit objective. As part of an on-going research, the next step will involve validating the framework through a mock testing process.展开更多
Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,whic...Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.展开更多
文摘A GIS audit framework is necessary considering the diverse nature of GIS with regard to components, applications and industry. In practice, checklists are generated during the audit process based on specific objectives. There is no standardized list of items that can be used as a reference. The purpose of this study was to develop a GIS audit framework as a foundation for GIS audits. The framework provides that comprehensive approach to various GIS aspects during the audit process. The design builds on a developed conceptual framework where most significant categories of GIS audit parameters namely data quality, software utilization, GIS competency and procedures (work flows) were identified. The study adopted a reductive model approach to simplify the complexity associated with each category of GIS audit parameter. The resultant audit elements for each category are organized in a matrix that forms an integral part of the framework. The columns comprise audit goal, audit questions and audit subjects as indicators which are qualitatively measured. The rows comprise the parameters (data quality, software utilization, personnel competency and procedure (workflows)). To use the framework, an auditor only needs to create an audit checklist that consists of particular parameters and indicators from the framework depending on audit objective. As part of an on-going research, the next step will involve validating the framework through a mock testing process.
文摘Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.
