Who needs to be audited?
The proposed rule requires that systems developers or vendors must be audited. If you are developing an in-house system that digitally signs, transmits or receives e222 forms, your system must also be audited. If you are purchasing a product that digitally signs, transmits or receives e222 forms, the software vendor that provides the system must be audited and provide you with proof of certification for that product-with-version. For both systems developers and vendors, an additional audit is required whenever signing or verifying functionality is changed. NOTE: All organizations handling Level I and II controlled substances are ultimately responsible for ensuring that they fully comply with DEA regulations regarding handling of Level I and II substances. Using software which has received CSOS certification in and by itself does not exempt organizations handling Level I and II controlled substances of this responsibility.
