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How Pfizer meets Quality Document Compliance in a highly regulated environment

Pfizer Inc. partnered with Pega to co-develop the Quality System for Document Compliance (QDoC) to greatly increase the efficiency in performing quality control reviews of regulatory submission documents. The project team leveraged a hybrid agile methodology that allowed for rapid development of a flexible document quality solution for regulatory submission documents to support more than 1000 reviews annually. This session will outline the hybrid agile methodology, integration to the PleaseReview system, lessons learned and how this solution could be applied to other industries.Pfizer Inc. partnered with Pega to co-develop the Quality System for Document Compliance (QDoC) to greatly increase the efficiency in performing quality control reviews of regulatory submission documents. The project team leveraged a hybrid agile methodology that allowed for rapid development of a flexible document quality solution for regulatory submission documents to support more than 1000 reviews annually. This session will outline the hybrid agile methodology, integration to the PleaseReview system, lessons learned and how this solution could be applied to other industries.


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Assunto: Conformidade Assunto: PegaWorld Industry: Saúde

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