# Using 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.

While the PSUR process, as well as object and action labels, may differ between organizations, the examples in this article assume a typical configuration. The procedure in your Vault may differ, depending on the [configuration](/en/lr/30980/) determined by your Admin. In this article, _Periodic Report_ is collectively referred to as _PSUR_.

## How PSUR Management Works

PSUR management in QMS centers around the PSUR (`periodic_report__v`) object, the _PSUR Template_ (`periodic_report_template__v`) object, and the _Create Record from Template_ user action on the _PSUR Template_ object.

The PSUR process typically involves creating a standard structure for the report, collaborating with stakeholders to author different sections, and collecting sets of documents to combine all of these elements into a single PDF document for submission. Vault allows you to create a _PSUR_  record manually or from a _PSUR  Template_. When you use the _Create Record from Template_ user action to create a _PSUR_ record from a template, Vault also creates any _PSUR Template Items_ that were included on the template. Each _PSUR Item_ refers to a section that needs to be added into the final report, for example, the Cover Page, Scope, _Complaints_ data, and so on.

Once all required documents are gathered and approved, you can generate a PDF document through the _PSUR: Generate Merged PDF_ action to combine all of the documents together for the final report.

## Example PSUR Process Overview

When performed in QMS, a typical PSUR process includes some or all of the following components:

* Create a _Periodic Report Template_ for PSURs. This step is usually performed once but may be performed whenever new templates are required.
* Create a _PSUR_ record. This step instantiates the workspace for your report's preparation.
* Add, modify, and assign _PSUR  Items_.This step ensures that your project is set up for success.
* Add documents to _PSUR Items_. This step allows assignees to mark items complete as they progress through the report.
* Generate the PSUR final report for submission.

## Creating Periodic Report Templates for PSURs

Only approved templates can be used to instantiate _PSUR_ records. Complete the following steps to create and approve a _PSUR Template_ for use in a typical PSUR process:

1. Navigate to the list of _Periodic Report Templates_ (`periodic_report_template__v`), and click to create a new _Periodic Report Template_ record.
2. Add the name of the template and provide the required metadata (_Product_, _Country_, and so on).
3. Create _PSUR Template Item_ records. These records designate what content needs to be collected to create the PSUR, such as the Cover Page, Scope, _Complaints_ data, and _Vigilance_ data.
4. Review and approve the template. The review and approval processes may be as simple or robust as your organization requires. A template is considered approved when it is in the _Approved_ state.

## Creating PSUR Records

You can create a _PSUR_ record manually to create a PSUR workspace. If your organization has predefined _PSUR Templates_, you can also use the following steps to create a PSUR from a template:

1. Navigate to a _PSUR Template_ record of the _PSUR_ object type, either in **Business Admin** or in a custom object tab, per your configuration.
2. Perform the **Create Record from Template** user action on the record. When you perform this action, Vault creates the _PSUR_ record, gives it a system-managed record name, and transfers data and _PSUR Template Item_-related records from the template to the new record. This new record is your project workspace for the new PSUR activity.

## Adding Documents to PSUR Items

The PSUR process typically includes gathering documents for inclusion in the final report. Each _PSUR Item_ can be assigned to an Owner who is responsible for adding a document to that _Item_ record. The required documents can be authored manually, created via templates, or created using the [Generate Document from Report](/en/lr/72016/#report-action) action.

## Generating PSUR Final Reports

Once the documentation and data in all associated _PSUR Item_ records have been finalized, a typical PSUR process includes the generation of a final report. To generate a single PDF document containing all documents referenced by the _PSUR Items_ in the _Periodic Report_ record, perform the **PSUR: Generate Merged PDF** action. When you perform this action, Vault creates the combined PDF document and stores it as a new document in the Vault, with the _Periodic Reports_ > _PSUR_ > _PSUR Final Report_ document type, and sets the value of the PSUR's _Final Report_ field, creating a link to the document from the _PSUR_ record. This link updates to the newly generated version of the document each time a user performs the _PSUR: Generate Merged PDF_ action on a given _PSUR_ record. If the action is unsuccessful, Vault displays a notification indicating the reasons for the failure and which specific document failed.

## Related Permissions

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

|Type|Permission Label|Controls|
|--- |--- |--- |
|Security Profile|Object: Periodic Report: View|Ability to view _Periodic Report_ records during the PSUR process.|
|Security Profile|Object: Periodic Report Template: View|Ability to view _Periodic Report_ _Template_ 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: Edit|Ability to edit _Periodic Reports_ during the PSUR process.|
|Security Profile|Object: Periodic Report Item: Edit|Ability to edit _Periodic Report Items_ during the PSUR process.|

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 _Periodic Report_ lifecycle.|
|Document Lifecycle (Editor role)|Version Document Source|Ability to version the document source in _Periodic Report_ lifecycle.|