Manual Reporting Setup

Please select the object link below for more information on how to configure the object.

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Numbering Schemes

Yes

Yes

Submission Status

No

Yes

Regulatory Reporting Policies

No

No

PDF Template Configurations

No

No

 

 

Numbering Scheme

Please see Numbering Scheme under System Wide Setup.

 

 

Submission Status

The default submission status can be changed from INWORKS to anything needed by the users. The following default statuses are available in the system:

Status

Submission Type

Description

INWORKS

Manual | eSubmission

This status displays next to any regulatory report that must be submitted as a result of the decision tree conclusion.

 

MANUAL

Manual

This status displays if any regulatory report was submitted manually.

 

PENDING

eSubmission

This status displays next to any regulatory report that was submitted to the regulatory agency and is awaiting regulatory approval.

 

FAILED

eSubmission

This status displays next to any regulatory report submitted to the regulatory agency and has failed any of the three acknowledgements.

 

PASSED

eSubmission

This status displays next to any regulatory report submitted to the regulatory agency and has passed the third Acknowledgement. This means that the eSubmission is now in the MAUDE database (only for eMDR).

 

 

How to Change Default Submission Status

With the introduction of the new submission status, it may be necessary for customers to set a different default than INWORKS when a report is required, based on the policy results in a decision tree. For example, if there are periodic reports that are necessary to be completed within a certain time frame, but are not dependent on the closure of the complaint record, then customers may want to change the status to something else, for example, PERIODIC. This will also enable customers to search this status over a period of time to find all the incidents that need to be included within their reports.

A tag can be added to any report defined in the FormsConfig.xml file so that when the decision tree is run, and that specific report is required, the status of that report will display as the default that is defined for the report.

NOTE: This does not apply to follow-up reports. It applies only to the initial report when the decision tree is run.

For example the user might add the following tag to a report that is defined as a quarterly submission report or a Periodic report. The following tag can be placed anywhere within the structure for a specific report.

DefaultSubmissionStatus="Periodic"

 

1.     From the SmartSolve\SubmissionForms folder, open the FormsConfig.XML file.

2.     Add the tag DefaultSubmissionStatus="Anything" anywhere for this report within the valid tag structure.

3.     Where Anything = whatever is required by regulatory personnel. This is the value displayed instead of INWORKS when the forms are initially created.

4.     Save the file.

 

    Regulatory Reporting Policy

Regulatory Reporting policies should be created for regulated companies who are required to report an adverse event report and have one or more of the following:

 

This type of policy provides the ability to identify the appropriate pre-defined numbering scheme and to generate the Manufacturer Report #on the MedWatch 3500A form based on which site is responsible for manufacturing or specification development of the product. The policy records information (which includes reporting site details) and is transferred to the Submission folder of the complaint after the decision tree is run.

NOTE: If a policy is not defined, the SmartComplaintsTM default numbering scheme for submission numbering is used for the submission form. Please see Numbering Schemes.

 

Once the numbering schemes are attached to the policies, they will transfer to the regulatory reports that are loaded from the complaint record.

 

 

User Rights

The following rights must be assigned to a user to manage or view Regulatory Reporting Policies:

Rights

Description

CSP_MANAGE

Allows administrator to add new Regulatory Reporting Policies, modify existing Policy, or delete Policies.

 

CSP_VIEW

Allows user to access Regulatory Reporting Policy to View.

 

 

      Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

·         Global Regulatory Reporting Policies will be inherited by all local organizations. 

·         Local Regulatory Reporting Policies will only be viewed and used within that local organization.

 

Writing the Policy

To write a regulatory reporting policy, you must be familiar with writing a test condition in SQL using the un-translated field names of any of the exception template entries driving the policy. These SQL statements are not checked; therefore, human intervention is required.

The following are lists of translated and untranslated fields for the regulatory reporting policy:

Translated Field

Untranslated Field

Manufacturing Site

CEX_MFCTR_SITE

 

Importer/Distributor Site

CEX_IMPRT_DIST

 

 

How to Create Regulatory Reporting Policies

1.   From the main menu select Admin > Policy > Exception/Issue Related > Regulatory Reporting Policy.

2.     Right click and select Add then select the Regulatory Body.

3.     Enter information in the following fields:

Field

Description

Regulatory Body

Select a regulatory body from the drop down list.

 

Test Sequence

Enter Test Sequence (system evaluates from lowest to highest sequence to see which sequence first meets this requirement).

 

Test Condition

Enter the Test Condition using the un-translated field name(s).

 

Test Description

Enter Test Description which will better explain what the Test Condition means in laymen’s terms.

 

Reporting By

Select the Reporting By site.

Manufacturing Site - The registered establishment (facility mfg/design) will report their MedWatch Report and will supply the contact. Configure the following fields:

Manufacturing Numbering Scheme

Manufacturing Site Registration Number

Manufacturing Site Contact

Reporting Site - Typically the company reporting group/division that submits the MedWatch reports for the products that they are responsible to maintain. Configure the following fields:

Reporting Site

Reporting Site Contact

The manufacturing site’s contact information that will populate into Section G of the MedWatch report for the FDA to contact if they have questions.

Importer/Distribution Site - The registered establishment (importer) that imports or distributes products that they do not manufacture or repackage. They will submit the Medwatch to the FDA and the manufacturer. Configure the following fields:

Importer/Distributor Numbering Scheme

Importer/Distributor Site Contact

 

Manufacturing Numbering Scheme

Zoom to select a numbering scheme.

Manufacturing Site Registration Number

Enter a registration number, if applicable.

Manufacturing Site Contact

Zoom to select a contact for the policy.

Reporting Site

Zoom to select a reporting site.

 

Reporting Site Contact

Zoom to select a reporting site contact, if applicable.

eSubmission Enabled

Check the eSubmission checkbox if eSubmissions will be used with this policy.

 

 

NOTE: this functionality turns on the ability to use the html template for data entry of a requlatory form which will create an xml file for submission.  Please see eMDR Reporting Setup and eMDV Reporting Setup

 

Importer/Distributor Numbering Scheme

Zoom to select a numbering scheme, if applicable.

eSubmission File Naming Format

Enter the eSubmission File Naming Format if eSubmissions will be used with this policy.

 

 

NOTE: The default naming convention is defined in the formconfig.xml file, if a unique name needs to be defined at the policy level, this allows the actual name of the xml file that is output to be configured.  Please see  eMDR Reporting Setup and eMDV Reporting Setup.

 

Importer Distributor Contact

Zoom to select a distributor contact, if applicable.

eSubmission Folder Path

Enter the eSubmission Folder Path if eSubmissions will be used with this policy.

 

 

NOTE: the eSubmission Folder Path can be defined in the FormsConfig.xml file as a default path and then specific folder paths can be defined here for either plant specific or product type output.

For Example: \\corpresearch\apps\RegulatoryAffairs\FDASubmissionFolder

Please see eMDR Reporting Setup

Add Another

Check this option if you wish to add another Regulatory Policy at this time.

 

4.     Click the Save button.

 

Managing Regulatory Reporting Policy Data

Regulatory reporting policies can be edited, deleted and managed accordingly by an administrator.

 

How to Edit Regulatory Reporting Policies

1.     From the SmartSolve© menu select Admin > Policy >Exception/Issue Related > Regulatory Reporting Policy.

The Regulatory Reporting Policies list displays.

2.     Click the  icon to switch to Local view (if applicable).

3.   Select the check box of the Policy to edit, then select Action > Edit from the main menu (or right click).

4.     Edit any information for your policy.

5.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Regulatory Reporting Policies

1.     From the SmartSolve© menu select Admin > Policy | Exception/Issue Related | Regulatory Reporting Policy.

The Regulatory Reporting Policies list displays.

2.     Click the  icon to switch to Local view (if applicable).

3.   Select the check box of the policy to delete, then select Action >Delete from the main menu (or right click).

4.     Click the Save button.

The policy has now been removed from the system.

 

PDF Templates

 

How to Access the PDF on the Server

The PDF="3500aForm.pdf " file is the Pilgrim provided, FDA approved, MedWatch template used to generate the PDF form. If the 3500a needs to be approved or changed this is the file that needs to be changed. Any changes made to this form need to be approved by the FDA.

Application Name\SubmissionForm\3500aForm.pdf

 

Fields Mapped from Exception to PDF

Significance of Mapped Fields

The complaint record fields described in the tables below map automatically to fields in the regulatory submission forms. All other fields on the submission forms must be entered manually.

Some mapped fields in the Complaint record are read-only in the form. Other mapped fields can be edited in the form. However, if the user edits the regulatory submission form itself without changing the same information in the Complaint record and then recreates the form, the edits in the form will be overwritten by the unchanged complaint record output.

For a follow-up form, it is possible to exclude fields that appeared in the original form. For further technical advice on excluding fields from follow-up forms, consult Pilgrim Professional Services.

 

MedWatch Form Page 1

Section

Field Title

Data Source

Field/Value/Comments

Header

Company Name

SubmissionForms\3500aForm.xsl

To be replaced by customer

Current Value:

"Your Company" should appear at the top center of each page of each form.

 

FDA facsimileMfr Report # approval

SubmissionForms\3500aForm.xsl

"Pilgrim Software Inc. FDA Facsimile Approval: 05/05/2006" should appear top right of the page on second line

 

Mfr Report #

Complaint/V_BAH_BASE_

ATTACH_CXP/BAH_REPORTNUMBER

This will be auto generated on Submit using the Numbering Scheme defined as follows:

a) If Submission Reporting Site = "Manufacturing Site" or "Reporting Site" and the Manufacturing Numbering Scheme is defined.

b) If the Manufacturing Numbering Scheme is NOT defined, the system will assign the number from the Numbering Scheme defined for the corresponding form type in the Formconfig.xml.

This value is populated only for "30-day MDR" and "5-day MDR/"

Format 9999999-YYYY-XXXXX

9999999 – Hard coded value by customer (your Manufacturing Registration Number)

YYYY - Replaced by current year

XXXXX – Actual report number increment (reset every year).

 

 

 

 

NOTE: If this value is populated, "UF/Dist report#" should not be populated.

 

 

UF/Dist report#

Complaint/V_BAH_BASE_ATTACH_

CXP/BAH_REPORTNUMBER

This will be auto generated on Submit using the Numbering Scheme defined as follows:

a) If Submission Reporting Site = "Importer/Distributor Site" and the Importer/Distributor Numbering Scheme is defined.

b) If the If importer/Distributor Numbering Scheme is NOT defined, the system will assign the number from the Numbering Scheme defined for the corresponding form type in the Formconfig.xml.

This value is populated only for "30-day MDR Distributor."

Format 9999999-YYYY-XXXXX

9999999 – Hard coded value by customer (your Distributor Registration Number)

YYYY - Replaced by current year

XXXXX – Actual Report number increment (reset every year)

 

 

 

NOTE: The value will support a UF 9999999999-yyyy-xxxxx value. The field will be an editable field to be manually entered before submission.

 

B

3. Date of event (mm/dd/yyyy)

QXP_OCCURENCE_DATE

Occurrence Date

 

4. Date of This Report (mm/dd/yyyy)

QXP_REPORT_DATE

Report Date

 

5. Describe event or problem

QXP_SHORT_DESC + QXP_

DESCRIPTION

This field should auto fill with the "Short Description" and/or "Description" from the Complaint Description section of the Exception form

D

1. Brand name

CXP_BRAND_NAME

Brand Name from product information section

 

4. Model #

PXP_PRODUCT_NAME

Part Name from the product Information section

 

4. Catalog #

CXP_CATALOG_NUMBER

Catalog Number from the product Information section

 

4. Expiration Date (mm/dd/yyyy)

CXP_EXP_DATE

Expiration Date from the product Information section

 

3. Manufacturer name & address

Complaint/MANUFACTURER

/ORU_NAME

Complaint/MANUFACTURER_

ADDRESS/PHY_CITY

Complaint/MANUFACTURER

_ADDRESS/PHY_STATE

Manufacture Name and Address for the manufacture site defined in the Additional folder

 

D. Suspect medical device

9. Device available for evaluation?

CEX_SMP_AVAILABLE

"Is Sample Available? from the Additional section

Possible Values : Yes/No

 

D. Suspect medical device

9. returned to manufacturer on (mm/dd/yyyy)

CEX_SMP_RECEIPT_DATE

Check the box and Sample Receipt Date in Additional Section

E

E. Initial reporter

1. Name, address & phone#

CMC_NAME

CMC_STREET

CMC_CITY, CMC_STATE CMC_ZIPCODE

CMC_COUNTRY

Contact Name

Street

City, State Zip

Country

Fax: Fax No

Email: Email_address

From the Contact folder for Contact Type = "CUSTOMER" (First record if there are two contacts with the type "CUSTOMER.")

 

Phone #

CMC_PHONE

Phone

From the Contact folder for Contact Type = "CUSTOMER" (First record if there are two contacts with the type "CUSTOMER.")

 

E. Initial reporter

3. Occupation

CMC_TITLE

Title

From the Contact folder for Contact Type = "CUSTOMER" (First record if there are two contacts with the type "CUSTOMER.")

  

 MedWatch Form Page 2 

Section

Field Title

Data Source

Field/Value/Comments

F

6. Date User Facility or Importer became Aware of Event

(mm/dd/yyyy)

CXP_AWARE_DATE

Incident Aware Date from the Customer Information section

 

8. Date of This Report

(mm/dd/yyyy)

QXP_REPORT_DATE

Report Date

 

2. UF/Importer Report Number

Complaint/V_BAH_BASE_ATTACH_

CXP/BAH_REPORTNUMBER

Same as UF/Dist report# under header section, and editable field for user to hand enter if required.

 

1. User Facility / Importer check box

 

Importer If Submission Reporting Site = "Importer/Distributor"

 

 

 

 

NOTE: User Facility Check box is not supported by system. It is user keyable.

 

 

3. User Facility or Importer Name and Address

 

If Submission Reporting Site = "Importer/Distributor", then name and address of Importer/Distributor Site defined in the Additional folder.

If Submission Reporting Site = "Reporting Site" then Name and address of Reporting Site defined in the Reporting Default.

 

4. Contact Person

 

Primary Contact of the Site defined in F3

 

5. Phone Number

 

Phone Number of the Primary Contact in F3

 

7. Type of Report

 

Auto-fill if this is an initial or follow-up report

If initial, check Initial box.

If follow-up: check Follow-up box and enter follow-up sequence number.

 

14. Manufacturer Name/Address

 

Name and Address of the Manufacturing Site defined in the Additional folder.

G

G. All manufacturers

1. Contact office, name, address

2. Phone

SubmissionForms\3500aForm.xsl

  • If Submission Reporting Site = "Manufacturing Site," the system will auto-populate the full name, primary contact and address information of the manufacturing site defined in the Additional folder.

  • Section G2 will populate with the primary contact's phone number of the Manufacturing Site.

  • If Submission Reporting Site = "Reporting Site" the system will auto-populate the full name, primary contact and address information of Reporting site defined in the Reporting Default.

  • Directly below the Vigilance information in section G1 will also include the word "Site" followed by the Manufacturing Site name and address.

  • Section G2 will populate with the primary contact's phone number of Reporting Site.

  • If Submission Reporting Site = "Importer/Distributor," this section will be blank

 

G. All manufacturers

4. Date received by manufacturer

(mm/dd/yyyy)

CXP_AWARE_DATE

This should auto fill with the Incident Aware Date under the Customer Information section.

 

G. All manufacturers

7. Type of report

BAH_CONCLSN_NAME

And

BAH_FOLLOWUP_NO

Check box checked based on the Form type selected:

30 Day – if 30-day MDR

5-Day – if 5-Day MDR

  • Initial – if the form is without follow-up

  • Follow Up – If the form type is Follow-up

  • Follow Up # - Follow-Up Number from the Submission Folder

 

9. Mfr report number

Complaint/V_BAH_BASE_ATTACH_CXP

/BAH_REPORTNUMBER

Same as "Mfr Report #" under Header section

H

H. Device manufacturers only

10. Additional manufacturer narrative

BTK_SIGNOFF_COMMENT

Investigation Result

From Resolution section:

"Additional Manufacturer Narrative" - The check box will be checked.

NOTE: This should auto-fill if the Results of Investigation task in the issue workflow is signed off

  

EMDV Form 

Section

Field Title

Data Source

Field/Value/Comments

P1 sec 2

b. Address

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value:

Your Street

Your City, Your State 99999

Your Country

 

c. Contact person Name

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value: Your Contact Name

 

e. Telefax Number

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value: (XXX)XXX-XXXX

 

d. Telephone Number

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value: (XXX)XXX-XXXX

 

f. Report date

QXP_REPORT_DATE

 

P2 sec 4

c) Model or Catalogue Number

CXP_CATALOG_NUMBER

Catalog Number from the Product Information section

 

d) Serial number(s) or lot number(s)

PXP_LOT_NUMBER

 

 

Address

CMC_STREET

CMC_CITY, CMC_STATE CMC_ZIPCODE

CMC_COUNTRY

Street

City, State Zip

Country

 From the Contact folder for Contact Type = CUSTOMER

 

j) Incident reported by (user or other source)

CMC_NAME

Contact Name

 From the Contact folder for Contact Type = CUSTOMER

 

Telephone number

CMC_PHONE

CMC_PHONE Phone

 From the Contact folder for Contact Type = CUSTOMER

 

Date reported

QXP_REPORT_DATE

 

 

k) Incident date

QXP_OCCURENCE_DATE

 

 

l) Incident description

QXP_SHORT_DESC & QXP_DESCRIPTION

This field should auto-fill with the "Short Description" and/or "Description" from the Complaint Description section of the Exception form.

 

p3_4n_ManufacturesComments

BTK_SIGNOFF_COMMENT

Investigation Result from the Resolution section.

 

 

 

NOTE: This should auto-fill if the Results of Investigation task in the issue workflow is signed off.

 

P4 sec 2

b. Address

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value:

Your Street

Your City, Your State 99999

Your Country

 

c. Contact Person Name

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value: Your Contact Name

 

d. Telephone Number

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value: (XXX)XXX-XXXX

 

e. Telefax Number

SubmissionForms\ EU-QR-P12-01MedForm01.xsl

To be replaced by customer.

Current Value: (XXX)XXX-XXXX

 

2.f) Date of this final report

QXP_REPORT_DATE

Catalog Number from the Product Information section.

P5 sec 4

c) Model or Catalogue Number

CXP_CATALOG_NUMBER

 

 

d) Serial number(s) or lot number(s)

PXP_LOT_NUMBER

 

P6 sec 4

m) Result and conclusion of manufacturer's investigation

BTK_SIGNOFF_COMMENT

Investigation Result

From the Resolution section.

 

 

 

NOTE: This should auto fill if the Results of Investigation Task in the issue workflow is signed off.

 

  

Canada TPP Form 

Section

Field Title

Data Source

Field/Value/Comments

General Information (P1)

2. Name of Reporter

QXP_REPORTER_NAME

 

 

4. Institution/

Company

CXP_CLIENT_NAME

 

 

5. Address

CMC_STREET, CMC_CITY, CMC_STATE, CMC_COUNTRY

CMC_TYPE= CUSTOMER

 

6. Postal Code

CMC_ZIPCODE

CMC_TYPE= CUSTOMER

 

7. Telephone

CMC_PHONE

CMC_TYPE= CUSTOMER

 

8. Fax

CMC_FAX

CMC_TYPE= CUSTOMER

 

9. Contact Person (if different from reporter)

CMC_NAME

CMC_TYPE= CUSTOMER

 

13. Is the device available for evaluation?

CEX_SMP_AVAILABLE

 

 

14. Date of Incident

QXP_OCCURENCE_DATE

 

 

15. Manufacturer/Importer Awareness Date:

CXP_AWARE_DATE

 

Medical Device Information

16. Trade Name

PXP_PRODUCT_NAME

 

 

17. Manufacturer Medical Device Identifier:

PXP_PRODUCT_CODE

 

Problem Description (P2)

41. Details of Incident Including Consequences to Patient, User or Other Person, and Description of Other Devices or Accessories Involved in the Incident

QXP_SHORT_DESC & QXP_DESCRIPTION

This field should auto-fill with the Short Description and/or Description from the Complaint Description section of the Exception form.

 

42. Manufacturer's Preliminary Comments

BTK_SIGNOFF_COMMENT

Investigation Result

From Resolution section.

 

 

 

NOTE: This should auto-fill if the Results of Investigation task in the issue workflow is signed off.

 

  

Australia TGA Form 

Section

Field Title

Data Source

Field/Value/Comments

Header

-Mfr report #

BAH_REPORTNUMBER

This will be auto-generated using the "Australia Numbering" Numbering Scheme.

Format: 9999999-YYYY-XXXXX

9999999 – Hard coded value by customer. (Your Manufacturing Registration Number)

YYYY - Replaced by current year

XXXXX – Actual Report number Increment (Need to reset Every Year)

I- Administrative Information

Date of this report (dd-mmm-yyyy

QXP_REPORT_DATE

 

 

Date of adverse event (dd-mmm-yyyy)

QXP_OCCURENCE_DATE

 

 

Date mfr aware (dd-mmm-yyyy

CXP_AWARE_DATE

 

Person (authorized representative) submitting this report

Name

CMC_NAME

 

 

Company

CMC_COMPANY

 

 

Address

CMC_STREET

CMC_CITY, CMC_STATE, CMC_ZIPCODE

CMC_COUNTRY

 

 

Tel

CMC_PHONE

 

 

Fax

CMC_FAX

 

 

E-mail

CMC_E_MAIL

 

III- Healthcare Facility Information

Name

CXP_CLIENT_NAME

 

 

Address

CMC_STREET

CMC_CITY, CMC_STATE, CMC_ZIPCODE

CMC_COUNTRY

 

 

Tel

CMC_PHONE

 

 

Fax

CMC_FAX

 

 

E-mail

CMC_E_MAIL

 

 

Contact name at site of event

CMC_NAME

 

IV- Device Information (Specific Device Information)

Brand Name

CXP_BRAND_NAME

 

 

Model #

PXP_PRODUCT_NAME

 

 

Catalogue #

CXP_CATALOG_NUMBER

 

 

Ser. or Lot #'s

PXP_LOT_NUMBER

 

II- Clinical Event Information

Description of event or problem

QXP_SHORT_DESC & QXP_DESCRIPTION

This field should auto-fill with the Short Description and/or Description from the Complaint Description section of the Exception form.

V- Results of Mfr's Investigation

Manufacturers Device Analysis Results

(Specify, for this event, details of investigation methods, results, and conclusions)

BTK_SIGNOFF_COMMENT

Investigation Result

From Resolution section

 

 

 

NOTE: This should auto-fill if the Results of Investigation task in the issue workflow is signed off.

 

  

Japan ARR Form 

Section

Field Title

Data Source

Field/Value/Comments

Appendix form 7

1. Control information

3) Date problem occurred

QXP_OCCURENCE_DATE

 

 

5) Date reported

QXP_REPORT_DATE

 

 

4) Date information received

CXP_AWARE_DATE

 

3. Information on medical device

1) Trade name of medical device

PXP_PRODUCT_NAME

 

 

3) Detailed information on medical device

QXP_SHORT_DESC & QXP_DESCRIPTION

 

4. Investigation results and countermeasures

1) Investigation results

BTK_SIGNOFF_COMMENT

 

1. Control information

Information received

 

 

 

4) Date reported

QXP_REPORT_DATE

 

2. Information on medical device

1) Trade name of medical device

PXP_PRODUCT_NAME

 

 

3) Detailed information on medical device

QXP_SHORT_DESC & QXP_DESCRIPTION

 

3. Investigation results and countermeasures

Content of Research

BTK_SIGNOFF_COMMENT

 

  

   

 

How to Map Fields from the Complaint to the PDF

The XSLT=”3500aForm.xsl” file is used to map the data fields from the complaint record to the MedWatch PDF form.

Application Name\SubmissionForm\FormConfig.xml

 

Example Scenario

The table below shows some fields that are normally mapped from the Complaint record into the HTML (3500aFormHtml.xsl) template or any PDF (3500aForm.xsl) report. The data fields that are available for mapping are located in the following views:

Field Label

Data Source

CustomerComplaint

V_CXP_CUSTOMER_PXP

 

AdditionalInfo

V_CEX_CXP_EXTENSION

 

SerialNumbers

V_PXS_PXP_SERIAL

 

Attachments

V_BAH_BASE_ATTACH_QXP

 

Contacts

V_CMC_CXP_CONTACT

 

Part

V_EPA_EXCEPTION_PART

 

Lots

V_EPL_EXCEPTION_PART_LOT

 

Submissions

V_BAH_BASE_ATTACH_CXP

 

GetInvestigationResult

 V_BTK_BASETASK

 

References Tab | External  Reference

Complaint/V_EXR_EXTERNAL_REFERENCE/EXR_REFERENCE_VALUE

 

 

NOTE: Each data field in the complaint record is associated with a specific view; basically use the prefix of the data field to find the appropriate view name to use in your expressions.  For example, if you want to use a user defined field, CEX_UDF_STRING_2 and map it over you will need to use the view: V_CEX_CXP_EXTENSION

 

How to Enable | Disable Follow-up Report Data

·         If the user does not want Complaint record data to flow into the follow-up reports, add an attribute called “NotInFollowUp”=”True”.

·         If the user wants data to flow into Follow-Up reports set the True to False; for example, “NotInFollowUp”=”False”

Application Name\SubmissionForm\3500aForm.Xsl

 

How to Rename Your Company on the MedWatch PDF

In the MedWatch PDF Report, the default Out of the Box PDF says Your Company.

 

The MedWatch PDF report needs to be changed to the company’s corporate name. This is setup once and will populate into all the MedWatch PDF files.

     1.   Access the folder - Application Name\SubmissionForms\3500aForm.xsl

     2.   Change Your Company to the name to be used for MedWatch reporting.