Building end-to-end compliant AS2 pipelines for electronic Medical Device Reporting.
The FDA Electronic Submissions Gateway generates three distinct receipts: ACK1 verifies receipt by the gateway, ACK2 confirms non-repudiation of receipt, and ACK3 reports XML schema and business rule validation. Our pipeline programmatically correlates all three tokens.
Every outbound eMDR payload is signed using X.509 PKI certificates recognized by the FDA gateway, ensuring complete legal non-repudiation and cryptographic audit trails for compliance inspections.