**Source URL:** https://quality.veevavault.help/en/lr/1224873/

# Configuring VMSR Reporting (Product Surveillance)

Your organization may opt to participate in the FDA's Voluntary Malfunction Summary Reporting (VMSR) program, which permits manufacturers to report certain device malfunction Medical Device Reports (MDRs) in an aggregated, summary format on a quarterly basis. This program is used by medical device manufacturers with a high volume of complaints to reduce the workload of filing individual eMDRs for every reportable complaint. Manufacturers need to submit separate summary reports for each unique combination of brand name, device model, and problem code(s). Each summary report identifies the total number of reportable malfunctions.

By leveraging configurable _Summary Report Profiles_, Product Surveillance can automatically assess _Complaints_ and _Reportability Assessments_ to determine if an incident qualifies for Summary Reporting, significantly reducing manual effort and assessment time for Vigilance Specialists and ensuring regulatory compliance.

## Managing Summary Report Profiles

_Summary Report Profiles_ define groups for summary reporting based on the _Product_ or _Product Variant_ and the severity.

Before creating _Summary Report Profile_ records, you must perform the following configuration steps:

* Display the following objects in Business Admin:  
  * **Summary Report Profile**  
  * **Summary Report Products Scope**  
  * **Summary Report - Codes**  
* Add the following _Related Object_ sections to the _Summary Report Profile_ object layout:  
  * **Summary Report Products Scope**  
  * **Summary Report - Code > Code**  
* Optional: Activate the **Override Justification** field on the _Reportability Assessment Effects_ object.

### Creating Summary Report Profiles

To create a _Summary Report Profile_:

1. Navigate to **Business Admin > Objects > Summary Report Profile** and click **Create**.  
2. Enter a **Name**.  
3. Select the **Allowed Severities**.  
4. Select a **Code Eligibility**.  
5. Optional: Select a **Country**.  
6. Optional: Select an **Expiration Date**.  
7. Select a **Start Date**.  
8. Optional: Enter an **HA Authorization Number**.  
9. Select a **Reporting Requirement**.   
10. Click **Save** or click **Save + Create** to add another _Summary Report Profile_.

### Creating Summary Report Product Scopes & Codes

To create a _Summary Report Product Scope_:

1. Navigate to **Business Admin > Objects > Summary Report Products Scope** and click **Create**.  
2. Enter a **Name**.  
3. Select the appropriate **Summary Report Profile**.  
4. Select one of following:  
   1. **Product Family**
   2. **Product**
   3. **Product Variant**
   4. **Material**
5. Click **Save** or click **Save + Create** to create another _Summary Report Products Scope_ record.

### Creating Summary Report - Codes

To create a _Summary Report - Code_:

1. Navigate to **Business Admin > Objects > Summary Report - Codes** and click **Create**.  
2. Select a **Summary Report Profile**.  
3. Select a **Code**.  
4. Click **Save** or click **Save + Create** to create another _Summary Report - Code_ record.

## Related Permissions

You can complete all the steps in this article with the standard _System Administrator_ or _Vault Owner_ security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

| Type | Permission | Controls |
| ----- | ----- | ----- |
| Security Profile | Object: _Summary Report Profile_: Read, Create, Edit, Delete | Ability to manage _Summary Report Profile_ records. |
| Security Profile | Object: _Summary Report Product Scope_: Read, Create, Edit, Delete | Ability to manage _Summary Report Product Scope_ records. |
| Security Profile | Object: _Summary Report - Codes_: Read, Create, Edit, Delete | Ability to manage _Summary Report - Code_ records. |