White Paper
Data Integrity in GxP Systems: Beyond the Audit Trail
Why ALCOA+ findings keep coming back after remediation, and how to close the process gaps that keep generating them.
Overview
Most data integrity remediation goes after systems. Audit trails get switched on, access controls get tightened, the finding closes. Two years later the same observation comes back, because the problem was never a technical one.
This paper looks at where data integrity breaks down in practice: the handoff between analyst and reviewer, the second-person review nobody has time to do properly, and the paper records that quietly shadow a validated system. It covers assessment, the order to remediate in, and how to show an investigator sustained control rather than a fix that happened to be in place on the day.
What you will learn
- Assess data integrity risk across process boundaries, not just system ones
- Apply ALCOA+ to hybrid paper and electronic workflows
- Design a second-person review that reviewers can finish in the time they have
- Evidence sustained control, not just closure
How Viltis helps
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