Data integrity: Principles of ALCOA+

To meet regulatory requirements, your laboratory data must be:

Attributable

to specific staff members via audit trails and eSignatures

Legible

for internal reference and audits, as well as regulatory inspections

Contemporaneous

so that data is recorded at the time that work is performed

Original

retained in the format in which they were originally generated

Accurate

using a system that minimizes errors, ensuring that raw data and analytical results are correctly presented

Complete

making sure everything is included, and nothing is missing

Consistent

based on a system that enforces use of approved data acquisition and analysis methods, reporting templates, and laboratory workflows

Enduring

using media that ensure records are maintained and protected

Available

so that records are accessible as needed