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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.
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 ...
The risk differentiation process requires the regulator to directly link a robust risk assessment, such as via a risk scoring model, to different regulatory responses (e.g. financial penalties, criminal imprisonment). Regulatory risk differentiation is also referred to as the Compliance Model in some regulatory agencies. [1]
The company was significantly restructured during 2000-2001, and under new management its offerings were marketed as Governance, Risk, and Compliance software and services sold to enterprise customers. Over the decade that followed OpenPages attracted more than 200 customers including Barclays, Duke Energy, and TIAA-CREF.
The Standard allows some discretion for each national authority to determine the due diligence approach, but only within minimum standards determined by the OECD: "The term "reportable account" means a [Jurisdiction A] reportable account or a [Jurisdiction B] reportable account, depending on the context, provided it has been identified as such ...
Interactive process simulation software with support for manufacturing, healthcare and supply chain. 2D and 3D visualization with VR capability Simantics System Dynamics: Free, Eclipse Public License (EPL) Java, Modelica: 2018 Free and open source system dynamics modelling software with stock and flow modelling, hierarchical models and array ...
A software package can read an SBML model description and translate it into its own internal format for model analysis. For example, a package might provide the ability to simulate the model by constructing differential equations and then perform numerical time integration on the equations to explore the model's dynamic behavior.
The Proceedings serve as the permanent record of all NAIC actions, including model laws and regulations, as well as committee and task force minutes and reports. The current and some archival issues of the Proceedings are publicly available for download in PDF format on the NAIC Publications department website. [4]