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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorCruzado Vélez, Héctor J.
dc.contributor.authorTorres, Omar A.
dc.date.accessioned2024-04-25T19:50:42Z
dc.date.available2024-04-25T19:50:42Z
dc.date.issued2018
dc.identifier.citationTorres, O. A. (2018). Computer System Validation Cycle Optimization [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/2467
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe concept of the project involves the optimization of a current Computer system validation cycle in an active project in the biopharma industry. The root cause for the problem was the excessive amounts of deviations that were being received due to a deficient document generation process. This has been solved by identifying a gap in the review process and putting in place an engineering subject matter expert to review the documents. The end state is reducing the amount of deviations obtained by document at the Quality Assurance level or during the execution. Upon verification, the implementation of technical engineering review layer deviations were reduced to the point of having significant savings towards project managing events. Thus confirming that by having a technical review after generation of the document gaps were reduced to half of what was expected originally. Key Terms ⎯ Computer System Validation (CSV), General Manufacturing Practices (GMP), Food and Drug Administration (FDA).en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManagement;
dc.relation.ispartofseriesSpring-2018;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Subject headings--Unassigneden_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Postersen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate School--Master in Engineering Management degreeen_US
dc.titleComputer System Validation Cycle Optimizationen_US
dc.typePosteren_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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    Articulos y Carteles de investigación (Poster): Ingeniería Gerencial (MEM) [San Juan, INTEC], Gerencia Ambiental (MEnvM) y Administración de Empresas (MBA)

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