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Office Open XML (also informally known as OOXML) [5] is a zipped, XML-based file format developed by Microsoft for representing spreadsheets, charts, presentations and word processing documents. Ecma International standardized the initial version as ECMA-376.
DOCX – Office Open XML document; DOT – Microsoft Word document template; DOTX – Office Open XML text document template; DWD – DavkaWriter Heb/Eng word processor file; EGT – EGT Universal Document; EPUB – EPUB open standard for e-books; EVTX – Windows XML EventLog files are system log files used by the Windows operating system [9 ...
Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation ...
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
Protected View is implemented as a separate child process instance of Excel, PowerPoint, and Word. The main process of each app is assigned the current user's access token and hosts the Office user interface elements such as the ribbon, whereas the Protected View process consists of the document viewing area, parses and renders the document ...
Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [ 1 ] outlining best practices regarding business process validation in the pharmaceutical ...