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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorGonzález Miranda, Carlos J.
dc.contributor.authorFigueroa Del Valle, Alois
dc.date.accessioned2021-03-18T15:07:46Z
dc.date.available2021-03-18T15:07:46Z
dc.date.issued2020
dc.identifier.citationFigueroa Del Valle, A. (2020). Quality alerts notifications evaluation and response solution for sites to communicate computer systems potential issues in an alignment form and integrated process [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1090
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe Quality Alert Process is used to communicate IT or computer system related situations that have the potential to adversely impact regulatory requirements (e.g. product quality, patient safety, record integrity and privacy) as well as potentially impacted sites/areas. In addition, the pharmaceutical industry is a highly and strictly regulated environment. Therefore, the data generated in this process are important in order to demonstrate compliance to the external agencies and patient safety. The Quality department is accountable for this process and, with the technology changes across the world, many business decisions are driven thru this department. A commercial off-the-shelf (COTS) software was identified to standardizing a global practice and replace/eliminate the manual and local process in the sites. This software helps communication to all the sites at the same time, with the same information, increasing and improving the process experience. To develop a global solution, Lean Six Sigma methodology were used to identify and implement the requirements to this process. Key Terms — Compliance, Quality Alerts, Response, Simplify, Standardize, Sustainable.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesWinter-2020;
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshTransaction systems (Computer systems)en_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleQuality Alerts Notifications Evaluation and Response Solution for Sites to Communicate Computer Systems Potential Issues in an Alignment Form and Integrated Processen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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