FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

To gzip files: gzip Utility at http://www.gzip.org/Apache Ant Java package should be integrated into the application when creating .tar.gz filesautomatically through the application.Appendix C. Digital CertificatesA digital certificate is an electronic document which conforms to the InternationalTelecommunications Union’s X.509 specification. It is a document which typically contains theowner’s name and public key, the expiration date of the public key, the serial number of thecertificate, and the name and digital signature of the organization which issued the certificate.The digital certificate binds together the owner’s name and a pair of electronic keys (a public keyand a private key) that can be used to encrypt and sign documents.Encrypting and digitally signing documents using certificates provides the following assurancesabout document transmissions:- Only the addressee (and no unauthorized users) can read the message. Encryptionprovides this assurance.- The message cannot be tampered with. That is, data cannot be changed, added, ordeleted without the sender’s knowledge. A document’s digital signature providesthis assurance.- Parties sending documents are genuinely who they claim to be. Likewise, whenthose parties receive documents signed by the sender, they can be confident aboutthe source of the documents. A document’s digital signature provides thisassurance.- The parties who send documents cannot readily claim they did not send them. Thisis referred to as non-repudiation of origin. A document’s digital signature providesthis assurance.- Parties who are sent documents cannot readily claim they did not receive them.This is referred to as non-repudiation of receipt. The signed documentacknowledgment provides this assurance.Using the certificationThe public key in the FDA’s certificate is used to encrypt a document for transmission. The FDAESG uses the public key to verify the digital signature of a document received from a specifiedsource.Before encrypted and signed documents (sent submissions) are exchanged with the FDA ESG,there must be a certificate exchange to obtain the other’s certificate and public key. Each partyobtains a certificate with a public-private key pair, either by generating a self-signed certificate