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The term regulatory state refers to the expansion in the use of rulemaking, monitoring and enforcement techniques and institutions by the state and to a parallel change in the way its positive or negative functions in society are being carried out. [1] The expansion of the state nowadays is generally via regulation and less via taxing and ...
SAP ERP is enterprise resource planning software developed by the German company SAP SE. SAP ERP incorporates the key business functions of an organization. The latest version of SAP ERP (V.6.0) was made available in 2006. The most recent SAP enhancement package 8 for SAP ERP 6.0 was released in 2016.
Executive Order 12866 in the United States, issued by President Clinton in 1993, requires a cost–benefit analysis for any new regulation that is "economically significant", which is defined as having "an annual effect on the economy of $100 million or more or adversely affect[ing] in a material way the economy, a sector of the economy, productivity, competition, [or] jobs," or creating an ...
The licensing process is specific to the regulatory environment of the jurisdiction where the bank is located. Licensing involves an evaluation of the entity's intent and the ability to meet the regulatory guidelines governing the bank's operations, financial soundness, and managerial actions.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Enterprise modelling is the process of building models of whole or part of an enterprise with process models, data models, resource models and/or new ontologies etc. It is based on knowledge about the enterprise, previous models and/or reference models as well as domain ontologies using model representation languages. [3]
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This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]