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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 first version of the TMF Reference Model (TMF RM) [5] was released in June 2010 and was updated in February, 2011 (v1.1) based on feedback provided by Regulators, and again in December, 2011 (v1.2), based on feedback provided by users of the model as they used it within their respective organizations to structure their paper and electronic ...
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 concept provides process models of enterprise operations. Process oriented modelling allows to represent the operation of enterprise entities and entity types in all its aspects: functional, behaviour, information, resources and organisation. Models which can be used for decision support by evaluating operational ...
SAP HANA Information Modeling (also known as SAP HANA Data Modeling) is a part of HANA application development. Modeling is the methodology to expose operational data to the end user. Reusable virtual objects (named calculation views) are used in the modelling process.
SAP PowerDesigner (or PowerDesigner) is a collaborative enterprise modelling tool produced by Sybase, currently owned by SAP. It can run either under Microsoft Windows as a native application or in an Eclipse environment through a plugin .
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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.