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Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]
Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:
Both free and paid versions are available. It can handle Microsoft Excel .xls and .xlsx files, and also produce other file formats such as .et, .txt, .csv, .pdf, and .dbf. It supports multiple tabs, VBA macro and PDF converting. [10] Lotus SmartSuite Lotus 123 – for MS Windows. In its MS-DOS (character cell) version, widely considered to be ...
The FDA has outlined a regulatory framework [1] for PAT implementation. With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the ...
Modular PDF software. Solid Converter PDF: Proprietary: Yes Yes Yes PDF to Word, Excel, HTML and Text; supports passwords, text editing, and batch conversion. SWFTools: GNU GPL: Yes Yes Yes Yes SWF conversion and manipulation suite containing a standalone PDF to SWF converter along with a Python gfx API (requires Xpdf).
A check sheet is a form (document) used to collect data in real time at the location where the data is generated. The data it captures can be quantitative or qualitative. When the information is quantitative, the check sheet is sometimes called a tally sheet. [1] The check sheet is one of the so-called Seven Basic Tools of Quality Control. [2]
Google Sheets is a spreadsheet application and part of the free, web-based Google Docs Editors suite offered by Google. Google Sheets is available as a web application; a mobile app for: Android, iOS, and as a desktop application on Google's ChromeOS. The app is compatible with Microsoft Excel file formats. [5]
Functional data analysis (FDA) is a branch of statistics that analyses data providing information about curves, surfaces or anything else varying over a continuum. In its most general form, under an FDA framework, each sample element of functional data is considered to be a random function.
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