Q&A library · compliance-guide
How do covered entities document 340B OPAIS annual recertification attestation support?
Covered entities should treat 340B annual recertification as a control activity, not just an OPAIS screen check. Before the responsible official attests, they should verify OPAIS against source documents, governance records, personnel and operational changes, and keep a contemporaneous review memo showing what was checked, discrepancies found, and how accuracy was confirmed.