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Business Process Validation (BPV) is the act of verifying that a set of end-to-end business processes function as intended. If there are problems in one or more business applications that support a business process, or in the integration or configuration of those systems, then the consequences of disruption to the business can be serious.
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 ]
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
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 ...
The Workflow Management Coalition, [6] BPM.com [7] and several other sources [8] use the following definition: Business process management (BPM) is a discipline involving any combination of modeling, automation, execution, control, measurement and optimization of business activity flows, in support of enterprise goals, spanning systems, employees, customers and partners within and beyond the ...
Validation during the software development process can be seen as a form of User Requirements Specification validation; and, that at the end of the development process is equivalent to Internal and/or External Software validation. Verification, from CMMI's point of view, is evidently of the artifact kind.
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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 ]