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The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
The Individual Master File (IMF) is the system currently used by the United States Internal Revenue Service (IRS) to store and process tax submissions and used as the main data input to process the IRS's transactions.
A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US.
The Death Master File is considered a public document under the Freedom of Information Act, and monthly and weekly updates of the file are sold by the National Technical Information Service of the U.S. Department of Commerce. [4] Knowing that a patient died is important in many observational clinical studies and is important for medical ...
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 Social Security Death Index (SSDI) was a database of death records created from the United States Social Security Administration's Death Master File until 2014. Since 2014, public access to the updated Death Master File has been via the Limited Access Death Master File certification program instituted under Title 15 Part 1110.
The Site Master file contains specific and factual GMP information about the production and control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file needs to ...
Managed file transfer, a technology that supports secure transfer of files within and among organizations; Master File Table, an integral component of the NTFS file system; Media Foundation Transform, a media processing plugin filter model in Microsoft Media Foundation