# Configuring Periodic Safety Update Reports (QMS)

QMS supports management of the Periodic Safety Update Report (PSUR) process, which facilitates the preparation and submission of PSURs for MedTech customers. PSURs are a regulatory requirement in the EU and provide clinical, commercial, and vigilance data, along with authored narratives and contextual content. Class IIa devices and above are required to submit a PSUR twice a year to EU health authorities. MedTech customers can manage the entire PSUR process in QMS, which can yield efficiencies through organization, template usage, and work item tracking.

This article contains basic configuration information to outline the PSUR process in your Vault.

## Configuration Overview

Configure the following components to use the PSUR functionality:

* Configure objects and page layouts for the _Periodic Report_ and _Periodic Report Item_ objects.
* Configure the object page layouts, lifecycles, and optionally, the review and approval workflows for _Periodic Report Template_ and _Periodic Report Item Template_.
* Configure the necessary document types and fields.
* Add the <a href="/en/gr/57968807/">Create Record from Template</a> user action on the _Periodic Report Template_ object.
* Add the _PSUR: Generate Merged PDF_ user or entry action to the _Periodic Report_ object.
* Create _Periodic Report Templates_ as needed for your processes.
* Optional: If you are leveraging _Periodic Report Templates_, create tabs or provide navigation tools for executors of _Periodic Reports_ to access the templates from which they create reports.

## Object Setup

Configure the following objects to support the PSUR process:

* _Periodic Report Template_ (`periodic_report_template__v`)
* _Periodic Report Template Item_ (`periodic_report_template_item__v`)
* _Periodic Report_ (`periodic_report__v`)
* _Periodic Report Item_ (`periodic_report_item__v`)

### Periodic Report Template Object

Make the following changes to the _Periodic Report Template_ object to support the PSUR process:

* Add the _Create Record from Template_ user action to the object configuration, typically in the _Approved_ state.
* Add a _Periodic Report Template Item_-related object section on the _Periodic Report Template_ object page layout for the _Periodic Report_ object type.

## Document Setup

Configure the following document types to support the PSUR process:

- _Periodic Reports_ (`periodic_reports__v`)
  - _PSUR_ (`psur__v`)
    - _PSUR Data_ (`psur_data__v`)
    - _PSUR Final Report_ (`psur_final_report__v`)

## Document Field Setup

When a user performs the _PSUR: Generate Merged PDF_ action, Vault will attempt to create a document of the _PSUR Final Report_ type. This generation can fail if that document type has required fields that cannot be set automatically during creation. Ensure that all required fields on the generated document type have default values.

## Object Lifecycle Setup

The PSUR process relies on several actions configured on the appropriate object lifecycle states of several objects' lifecycles.

### Periodic Report Template Lifecycle

Add the _Create Record from Template_ user action to the _Periodic Report Template Lifecycle_ in an appropriate state so that users can create _Periodic Reports_ from the established template.

### Periodic Report Lifecycle

Add the _PSUR: Generate Merged PDF_ action to an appropriate state in the _Periodic Report Lifecycle_. This action generates the PSUR final report, so it should be added to a state after all documents for the PSUR have been approved.

## Related Permissions

Your security profiles require the following permissions to work with PSURs:

|Type|Permission Label|Controls|
|--- |--- |--- |
|Security Profile|Object: Periodic Report Template: Create, Edit, View|Ability to create, edit, and view _Periodic Report Template_ records during the PSUR process.|
|Security Profile|Object: Periodic Report Template Item: Create, Edit, View|Ability to create, edit, and view _Periodic Report Template Item_ records during the PSUR process.|
|Security Profile|Object: Periodic Report: Create, Edit, View|Ability to create, edit, and view _Periodic Report_ records during the PSUR process.|
|Security Profile|Object: Periodic Report Item: Create, Edit, View|Ability to create, edit, and view _Periodic Report Item_ records during the PSUR process.|
|Security Profile|Object: Periodic Report Template: Execute|Ability to execute the _Create Record from Template_ user action.|
|Security Profile|Object: Periodic Report: Execute|Ability to execute the _PSUR: Generate Merged PDF_ action.|

Users require the following lifecycle state role permissions for the _Periodic Reports_ lifecycle:

|Type|Permission Label|Controls|
|--- |--- |--- |
|Document Type (PSUR Final Report)|Create Document|Ability to create a _PSUR Final Report_ using the _PSUR: Generate Merged PDF_ action.|
|Document Type (PSUR Final Report)|View Document|Ability to view a _PSUR Final Report_.|
|Document Type (PSUR Final Report)|Edit Document|Ability to edit a _PSUR Final Report_.|
|Document Lifecycle (Editor role)|View Document|Ability to view documents in the _Periodic Report_ lifecycle.|
|Document Lifecycle (Editor role)|View Content|Ability to view content in the _Periodic Report_ lifecycle.|
|Document Lifecycle (Editor role)|Edit Fields|Ability to edit fields in the _Periodic Report_ lifecycle.|
|Document Lifecycle (Editor role)|Version Document Source|Ability to version the document source in the _Periodic Report_ lifecycle.|