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Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
Master data management (MDM) is a discipline in which business and information technology collaborate to ensure the uniformity, accuracy, stewardship, semantic consistency, and accountability of the enterprise's official shared master data assets.
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations .
Excel-related file extensions of this format include:.xlsx – Excel workbook.xlsm – Excel macro-enabled workbook; same as xlsx but may contain macros and scripts.xltx – Excel template.xltm – Excel macro-enabled template; same as xltx but may contain macros and scripts; Other formats Microsoft Excel uses dedicated file formats that are ...
Master data represents "data about the business entities that provide context for business transactions". [1] The most commonly found categories of master data are parties (individuals and organisations, and their roles, such as customers, suppliers, employees), products, financial structures (such as ledgers and cost centres) and locational concepts.
ISO 8000 is the international standard for Data Quality and Enterprise Master Data.Widely adopted internationally [1] [2] [3] it describes the features and defines the requirements for standard exchange of Master Data among business partners.
The replacement documents include DI-MGMT-81650 (Integrated Master Schedule), DI-MGMT-81334A (Contract Work Breakdown Structure) and DI-MGMT-81466 (Contract Performance Report). [14] [15] [16] In addition DFARS 252.242–7001 and 252.242–7002 provide guidance for integrating IMP/IMS with Earned Value Management.
While many electronic document management systems store documents in their native file format (Microsoft Word or Excel, PDF), some web-based document management systems are beginning to store content in the form of HTML. These HTML-based document management systems can act as publishing systems or policy management systems. [1]