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Industrial process data validation and reconciliation, or more briefly, process data reconciliation (PDR), is a technology that uses process information and mathematical methods in order to automatically ensure data validation and reconciliation by correcting measurements in industrial processes.
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 ]
Analyse-it is a statistical analysis add-in for Microsoft Excel. Analyse-it is the successor to Astute, developed in 1992 for Excel 4 and the first statistical analysis add-in for Microsoft Excel. Analyse-it is the successor to Astute, developed in 1992 for Excel 4 and the first statistical analysis add-in for Microsoft Excel.
Data validation is intended to provide certain well-defined guarantees for fitness and consistency of data in an application or automated system. Data validation rules can be defined and designed using various methodologies, and be deployed in various contexts. [1]
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.
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 ]
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 ...
In 2000, Microsoft released an initial version of an XML-based format for Microsoft Excel, which was incorporated in Office XP. In 2002, a new file format for Microsoft Word followed. [ 9 ] The Excel and Word formats—known as the Microsoft Office XML formats —were later incorporated into the 2003 release of Microsoft Office.