FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
organization’s security policy. The decision of who to trust rests with the individualorganization.In-HouseAn in-house PKI makes it possible to achieve complete control of security policies andprocedures. It also carries the burden of management and cost to set up and maintain the system.FDA recommends using certificates with 3 years validity.OutsourcedThird-party certificate authorities can be leveraged to purchase X.509 certificates for general use.The CA manages the security policies and details such as certificate revocation. The level ofoutsourcing can range from purchasing a public key certificate that is valid for 1 year to 3 yearsfrom a commercial CA, to outsourcing all of the PKI services that an organization requires.If you plan to use an outsourced certificate, the following are just a few of the many companiesthat sell the X.509 certificates (Displayed in alphabetical order).FDA recommends using certificates with 3 years validity.- Comodo:https://secure.instantssl.com/products/frontpage?area=SecureEmailCertificate- GeoTrust: http://www.geotrust.com/signing-products/secure-email/index.html- GlobalSign:http://www.globalsign.com/digital_certificate/personalsign/index.htm#2- TrustCenter: http://www.trustcenter.de/en/products/tc_personal_id.htm- Verisign: http://www.verisign.com/authentication/individual-authentication/digitalid/index.htmlNote: References to commercial products are for illustrative purposes only and does notconstitute an official FDA endorsement.CA will send you an email with PIN number and a link to a website where you can import/installthe certificate. Accept all defaults and say "yes” to all pop-ups, your certificate will be installedin your browser. Note, if you are using WebTrader, you do not have to install the certificate onthe same machine that you will be using. Once the certificate is installed in the browser you canexport the public and private keys out and use them where ever you want. AS2 users will need toinstall the certificates in their system. Configuring the certificates may defer from sponsor tosponsor depending on what gateway software being used.1. From Internet Explorer go to Tools Internet Options Content tab Certificates2. Select your certificate in the Personal tab.
3. Click on the Export button to create public and private keys, which can be used for theGateway.4. To export public key (.cer or .p7b) select Next on the next screen5. Select No, do not export the private key option and click on the Next button.
- Page 1 and 2: FDA Electronic Submissions Gateway
- Page 3: Appendix C. Digital Certificates...
- Page 6 and 7: Figure 1: Overview of the Registrat
- Page 8 and 9: 2.6 Send Submissions to the Product
- Page 10 and 11: eCTD - Electronic Common Technical
- Page 12 and 13: FDAPreparation of multi-filesubmiss
- Page 14 and 15: 3.7 Help and InformationThere are r
- Page 16 and 17: 4. Click the Next button.The Pick a
- Page 18: 8. Click the Next button.The Locate
- Page 21 and 22: 14. Enter a new login User ID and P
- Page 23 and 24: Confirm that the correct version of
- Page 25 and 26: 7. Select the Send document menu it
- Page 27 and 28: - Load tests ensure that you are ab
- Page 29 and 30: 20. To access the receipt, click on
- Page 31 and 32: 4.4 Apply for a Production System A
- Page 33 and 34: submissions (> 7.5 GB), this can ta
- Page 35 and 36: When a Center receives a submission
- Page 37 and 38: The following information is requir
- Page 39 and 40: Be sure to indicate on the applicat
- Page 41 and 42: - Create a local environment that s
- Page 43 and 44: ___________________________________
- Page 45 and 46: Upon receiving the file, signature
- Page 47: or by obtaining a certificate from
- Page 51 and 52: 9. Give a file name and select the
- Page 53 and 54: 4. Create a password for your priva
- Page 55 and 56: 2. Select "Windows" from the platfo
- Page 57 and 58: 2. Click on the link under Required
- Page 59 and 60: 4. With the box unchecked, a warnin
- Page 61 and 62: . From the Add or Remove Programs d
- Page 63 and 64: Appendix E. Glossary of TermsTable
- Page 65 and 66: Appendix F. AcronymsA list of acron
- Page 67 and 68: Table G-1: Allowable Center Attribu
- Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
- Page 71 and 72: EDIFACT UNB Header InformationDescr
- Page 73 and 74: Consult with an FDA Center represen
- Page 75 and 76: Figure 3: File System Settings, Dir
- Page 77 and 78: 6. Click on the Save changes button
- Page 79 and 80: Figure 7: Submission Types Supporte
3. Click on the Export button to create public and private keys, which can be used for the<strong>Gateway</strong>.4. To export public key (.cer or .p7b) select Next on the next screen5. Select No, do not export the private key option and click on the Next button.