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Peer Review: Utilizing the Quality Management System to Assure Data Integrity

Description

Review and address improvements to finalize the Technical Report (TR). This TR was developed by the global pharmaceutical industry to summarize a risk-based data governance model with the objective of assuring data integrity compliance by design for GxP data and information. In addition to the operationalization of data governance and data management through the integration of requirements and controls within quality system elements, this technical report addresses the influence and expectations of leadership, quality culture, and management responsibilities.

PDA technical documents undergo external review to provide high quality, valuable resources for the pharmaceutical industry. Reviewers from all levels of experience and geographies are encouraged to participate to ensure the documents are accessible and relevant to a wide audience.