Data Integrity & ALCOA+ Compliance

Data integrity ensures that regulated data are accurate, complete, and reliable throughout their lifecycle. FDA data integrity expectations are commonly summarized through the ALCOA+ principles, which emphasize data being attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.

Data integrity applies across clinical, laboratory, manufacturing, and quality systems. Weak data governance or poor controls can result in significant regulatory findings, even when underlying processes appear compliant.

Effective data integrity programs focus on system design, procedural controls, and organizational awareness.

Data integrity and ALCOA+ activities often include:

• Data flow and system mapping

• Data integrity risk assessments

• Review of controls and access management

• Procedural and documentation alignment

• Inspection readiness related to data integrity