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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorGonzález Miranda, Carlos J.
dc.contributor.authorSoto Cruz, Alexandra
dc.date.accessioned2020-07-15T13:03:57Z
dc.date.available2020-07-15T13:03:57Z
dc.date.issued2017
dc.identifier.citationSoto Cruz, A. (2017). Validation exercise for upgrade of the Systech’s Serialization Program v8.01 at a packaging line [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/378
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractSerialization has been the focus during the past years due to the new worldwide regulation related to the track and trace of pharmaceutical products. Companies dedicated all their efforts incorporating new technology to their actual packaging lines. Some has to update their serialization systems versions to improve their process. For this update a complete validation strategy and exercise was developed: from Commissioning and Qualification to Packaging Line Integration. Eight protocols were executed, documents were updated and reports were generated to assure the system was satisfactorily upgraded. From 3721 steps executed, 96.60% passed right and 131 steps failed generating 59 discrepancies and 7 re-test exercises related to protocol errors, error in reference documents and equipment failure. It was concluded that main offenders were Lack of Information, Human Error, Wrong Information found on Vendor’s documents and Configuration errors. A closing meeting was held to identify lessons learned and improvement’s opportunities for upcoming upgrades. Key Terms - Packaging, Serialization, Upgrade, Validation.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.lcshComputer programs--Validation
dc.subject.lcshPackaging
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleValidation Exercise for Upgrade of the Systech’s Serialization Program v8.01 at a Packaging Lineen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Ricoen_US


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