Processes to protect data integrity and reliability are paramount to support patient safety and product quality. However, the “controls for data integrity do not necessarily guarantee the quality of the data generated”, as recently recognized by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) in its ‘GxP’ Data Integrity Guidance and Definitions, March 2018. This poster highlights how one company, RTI Health Solutions, has implemented a quality management process to assure data quality in its research output, with a focus on minimizing the risk of scientific or statistical errors and misinterpretation. This quality management process is aligned with the Plan-Do-Check-Act (PDCA) framework and incorporates a control strategy which holds staff accountable for data quality at critical document deliverable stages. This poster provides an overview of the company’s three layers of data quality control that (1) confirm the accuracy of data, information, and analysis; (2) verify the validity of the scientific content and interpretation; and (3) ensure that the appearance and writing meet internal quality standards. Compliance with the data quality management process is monitored through internal process audits, client project audits and customer satisfaction reporting. The poster concludes with high-level metrics to illustrate the impact of implementing these quality management processes to assure data quality.
