The Importance of Data Integrity in the Laboratory: Adhering to FDA Standards and ALCOA Principles

In today’s highly regulated laboratory environment, maintaining data integrity is not just a matter of good practice—it’s essential for compliance, reliability, and the overall success of lab operations. For lab managers and IT support staff, ensuring data integrity means safeguarding data’s accuracy, completeness, and consistency throughout its lifecycle.

‍Most off-the-shelf lab informatics systems include robust data integrity controls, providing labs a headstart on data integrity. However, when labs add instruments and equipment to their workflows, they often transfer information between this hardware and their existing software systems via files. When they do this, they may unintentionally weaken data integrity and even become non-compliant.