Failure to define and implement good data management practices can impact data reliability and completeness and undermine the robustness of decision-making based upon those data records. This one-day course offers an insight into how a GxP organization can integrate sound scientific principles into data processes to ensure regulatory expectations for data integrity are met.
Concepts of the modern quality system are illustrated such as culture, the role of senior management and quality risk management across the data lifecycle. These concepts are applicable irrespective of whether a paper, electronic or hybrid documentation system is used.
Utilizing a modern approach streamlines data processes in a manner that not only improves data management and integrity but also improves process efficiency and effectiveness, thereby reducing costs and facilitating continual improvement.