Frequently asked question
What should a data-integrity remediation program include beyond audit-trail review?
Audit-trail review is only one control within a broader data-governance system. A credible remediation program may need to define the scope and independence of retrospective review, establish a defensible review methodology, identify unofficial or…
Answer
Audit-trail review is only one control within a broader data-governance system. A credible remediation program may need to define the scope and independence of retrospective review, establish a defensible review methodology, identify unofficial or shadow systems, assess access and role design, and confirm how data are created, processed, reviewed, retained, backed up, and retrieved. It should also address governance, escalation, training, management oversight, and quality culture. The central question is whether decisions can be reconstructed from complete, contemporaneous, attributable, and reliable records — not whether a single procedural checkbox exists.
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