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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorMorales Morales, José A.
dc.contributor.authorRamos, Tania
dc.date.accessioned2022-12-22T12:29:04Z
dc.date.available2022-12-22T12:29:04Z
dc.date.issued2022
dc.identifier.citationRamos, T. & Morales Morales, J. A. (2022). Using Six Sigma in a Computer System Validation Project in a GMP environment [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1783
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractComputer Systems Validation is a process used to test, validate, and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable, and traceable. This this is done under a very regulated environment. Biopharma industries use computerized systems like DeltaV™, an automation system that simplifies operational complexity. The Delta V™ is an easy-to-use system that simplifies operational complexity and lowers project risk. Six Sigma is a business management strategy used by different industries to improve the quality of products or services produced by the business through the removal of defects and errors. The Six-Sigma methodology is to improve a process with a positive implication on quality of product or, such as this case, a service in the Information Systems Department, to reduce Computer System Validation delays in the IS Department to zero days in a GMP environment. Key terms -- computer system validation, defects, GMP environment, Six Sigma.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesFall-2022;
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Postersen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshComputer software--Validation
dc.titleUsing Six Sigma in a Computer System Validation Project in a GMP environmenten_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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