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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorTorres, Edgar
dc.contributor.authorCádiz García, Osvaldo R.
dc.date.accessioned2020-07-15T17:54:02Z
dc.date.available2020-07-15T17:54:02Z
dc.date.issued2017
dc.identifier.citationCádiz García, O. R. (2017). Data integrity implementation strategy for pharma industry [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/399
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractData integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality as decisions on product quality are made based on the data. Electronic data and computerized systems have introduced new challenges to maintain data integrity; hence the data governance system should be integral to the pharmaceutical quality system as required by regulatory authorities as Food and Drug Administration (FDA) and Healthcare Products Regulatory Agency (MHRA). Data integrity requirements apply equally to manual (paper) and electronic data. The regulatory authorities have put much emphasis on data integrity in recent years because they uncovered serious cases of data integrity breaches. This project supports the pharma industry goal and success of operational excellence with zero FDA’s alerts related to Data Integrity. This should also be a model to all plant sites within the same problem and avoid CGMP’s violations or issues involving data integrity. Key Terms - ALCOA, Data Integrity, ERES, GMP’s.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesFall-2017;
dc.relation.haspartSan Juanen_US
dc.subject.lcshData integrity
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleData Integrity Implementation Strategy for Pharma Industryen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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