Additional Windchill Capabilities > Windchill Quality Management Solutions > The Windchill Customer Experience Management Process > Regulatory Decisions and Reports > eMDR Process Overview > Setting Up Electronic Submissions for eMDRs
  
Setting Up Electronic Submissions for eMDRs
To begin using eMDRs with your Windchill Quality Management Solutions installation, do the following:
1. Send an email to esgprep@fda.hhs.gov requesting a test account registration URL.
2. Register online for the FDA ESG at https://esg.fda.gov/.
3. Send a letter of non-repudiation to authenticate your digital identity.
4. Purchase a digital certificate.
◦ The certificate must be an X.509 version 3 certificate. All data in the Issuer and Subject fields must be completed.
◦ The FDA has some constraints on the number of years the certificate is valid (typically 1-3 years).
5. Contact the Center for Devices and Radiological Health (CDRH) at emdr@fda.hhs.gov to let them know you plan to conduct internal testing using HL7 ICSR submissions.
6. Implement an AS2 server to perform the submission to the FDA AS2 gateway and to process the acknowledgements.
◦ The AS2 gateway server is not embedded with Windchill and not provided by PTC.
◦ The AS2 gateway server must be installed and configured separately. For installation, configuration, maintenance, and other issues, contact the software vendor for the AS2 gateway server.
7. Optionally, in Windchill, change the file drop location.
The Windchill Customer Experience Management module uses file drop functionality to save the HL7 message in an outbox folder to be processed by the AS2 server and sent to the gateway. Acknowledgements returned from the gateway to the AS2 server must be written to an inbox folder to be picked up automatically by Windchill.
The default location for the file drop folders is in the Windchill temp directory $(wt.temp) in filedropfdacommunications\<location>, where <location> is out, in, or orphan.
To change the location for any of the file drop folders, update the QMS.fdacommunicationfiledrop.properties.xconf file located at <Windchill>\codebase\com\ptc\qualitymanagement\qms\xconfs.
This configuration file has five entries:
File Entry
Description
An outbox location for outgoing HL7 messages
This location can only be modified using the following xconfmanager command:
<Property default="$(wt.temp)/filedropfdacommunications/out/"
name="com.ptc.qualitymanagement.QMS.FDA.fileDropOutputDirectory"/>
An inbox location of incoming acknowledgements from the FDA
• This location can only be modified using the following xconfmanager command:
<Property default="$(wt.temp)/filedropfdacommunications/in/"
name="com.ptc.qualitymanagement.QMS.FDA.fileDropInputDirectory"/>
• Windchill monitors this folder and automatically processes incoming acknowledgements.
• For more information about the purpose of each received acknowledgement, see the “eMDR Workflow” section in eMDR Process Overview.
• Acknowledgement #1 (ACK1) is generated when the submission reaches the ESG (FDA Gateway server). ACK1 must be generated by the AS2 server, and the first line must contain the file name that was submitted to the AS2 server. This file is stored in the inbox folder defined in the QMS.fdacommunicationfiledrop.properties.xconf file. The message ID is enclosed in <> brackets with the message ID generated by the AS2 server.
The following is an example of an ACK1 file:
fda_e0e6ebd2-8cf6-41cd-acef-e33b3f54ca92.tar.gz
<mendAS2-1389394654277-62@175749431_ZZFDATST>
• • Acknowledgement #2 (ACK2) contains the information that is sent to the AS2 server from the FDA when the submission reaches the CDRH (Center of Devices and Radiological Health).
The following is an example of an ACK2 file:
MessageID: <mendAS2-1389394654277-62@175749431_ZZFDATST>
CoreId: ci1389364942307.54077@fdsul05626_te2
DateTime Receipt Generated: 01-10-2014, 09:42:55
File Count: 1
Directory Count: 1

CDRH has received your submission
• Acknowledgement #3 (ACK3) contains the information that is sent to the AS2 server from the FDA when the CDRH validates and loads the submission into the Adverse Event database (MAUDE).
The following is an example of an ACK3 file:
<submission>
<coreId>ci1389364942307.54077@fdsul05626_te2</coreId>
<batchId>3</batchId>
<dateEntered>01-10-2014, 09:42:55</dateEntered>
<numReportFailed>0</numReportFailed>
<numReportPassed>1</numReportPassed>
<report id='12345678900005'>
<status>passed</status>
</report>
</submission>
• The ACK files can have any extension or no extension. If there is a file in the inbox, it is opened and evaluated by Windchill to determine if it is an ACK1, ACK2, or ACK3.
• Windchill does not store the ACK files. The contents of the ACK files are evaluated and stored in the submission tables. The attributes found in the ACKs can be viewed in the submission information for eMDRs in Windchill Customer Experience Management.
◦ ACK1 contains a communication ID, which is the original file name, and a message ID, which is generated by the AS2 server.
◦ ACK2 contains a message ID and a core ID, which is generated by the FDA.
◦ ACK3 contains a core ID and a submission status of success or failure. If an ACK3 indicates a failure, the error messages are stored and are visible in the submission information.
• After the ACK files are processed by Windchill, they are deleted from the inbox folder. If it is important to view or store the actual contents of the ACK files, then the AS2 server must be configured appropriately to keep copies of the ACK files.
An orphan location for incoming acknowledgements from the FDA that cannot be linked to a previous communication
The following property specifies the location of the orphan directory:
<Property default="$(wt.temp)/filedropfdacommunications/orphan/"
name="com.ptc.qualitymanagement.QMS.FDA.fileDropOrphanDirectory">
The orphan directory is used to store acknowledgements that cannot be processed due to one of the following conditions:
• If the file contains ACK1 information (the original submission file name and a message ID) and the original submission file name does not match the communication ID of an existing submission, the file is placed in the orphan folder. This issue generally does not happen unless there is a problem with the AS2 server generating the correct information to be placed in the acknowledgements.
• If the file contains ACK2 information and the system cannot match the message ID to the message ID in an existing valid submission, the file is placed in the orphan folder. This can occur if the ACK1 for the submission has not been processed yet, if the ACK1 is missing, or if both the ACK1 and ACK2 are placed in the inbox at the same time and the ACK2 is picked up first.
• If the file contains ACK3 information and the system cannot match the core ID to the core ID in an existing valid submission, the file is placed in the orphan folder. This usually occurs when the FDA returns an ACK3 but not an ACK2 for a submission. This can happen when the FDA ESG gateway experiences problems. This can also occur if the ACK2 and ACK3 are placed in the inbox at exactly the same time, and the ACK3 is picked up first.
When the file drop service activates, it scans the orphan folder to verify if there are any files present. If files are present, then Windchill attempts to process them. For example, an ACK was placed in the orphan folder because the previous ACK had not been processed yet. Once the previous ACK is processed, the ACK in the orphan folder is then processed successfully.
A targz location
This location is only used for UDI and not for Windchill Customer Experience Management.
The files for UDI submissions are packaged in a tar.gz format while the files for eMDRs are packaged as XML files.
The following property specifies the location of the targz directory:
<Property default="$(wt.temp)/filedropfdacommunications/targz/"
name="com.ptc.qualitymanagement.QMS.FDA.fileDropTarGzDirectory"/>
A fileDropWaitTime entry
This entry is only used for UDI and not for Windchill Customer Experience Management.
This property specifies the wait time to check the files in the directories for processing.
The following property specifies the fileDropWaitTime:
<Property default="10000"
name="com.ptc.qualitymanagement.QMS.FDA.fileDropWaitTime"/>
8. In Windchill, configure the preferences for sending eMDRs.
a. From the Navigator, click the quality icon for your quality context.
b. Click Utilities > Preference Management.
c. Under the Quality section, right-click eMDR Submission Mode and select Set Preference. From the Value list, select Test and click OK. This setting adds a prefix of 7 to eMDR numbers for test submissions to comply with FDA rules.
d. Right-click FDA Manufacturer Registration Number and select Set Preference. In the Value field, enter the FDA manufacturer registration number for your company and click OK.
* 
There are additional UDI properties that are not used by CEM, so you do not need to update them.
9. Test your data.
◦ Any type of data can be submitted for your testing, because the data is loaded only in the test database.
◦ If necessary, you can ask the CDRH to send the PDF that is generated on their end to verify a successful submission during informal testing.
10. Contact the CDRH again at emdr@fda.hhs.gov to let them know you plan to conduct formal testing. Send the report number, core ID, XML, and the PDF that is generated in Windchill for each submission so the CDRH can verify their success. The following submissions must pass testing to receive a production account from the FDA:
◦ Initial 3500A form
◦ Initial 3500A form with an attachment
◦ Initial 3500A form followed by a supplemental 3500A form (Submit the supplemental form after the initial form is loaded successfully.)
◦ Initial 3500A form with section F completed (Section F is used to provide information from a user facility or importer source report.)
◦ Initial 3500A form and source reports
For additional instructions, see the following websites:
• Electronic Submissions Gateway at http://www.fda.gov/esg
• eMDR – Electronic Medical Device Reporting at http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/emdr%E2%80%93electronicmedicaldevicereporting/default.htm
• FDA Electronic Submission Gateway (ESG) Update at http://www.fda.gov/downloads/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm229728.pdf
• AS2 Gateway-to-Gateway Electronic Submission at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm334502.htm