Using Periodic Safety Update Reports (QMS)

Vault 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 Vault 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 determined by your Admin. In this article, Periodic Report is collectively referred to as PSUR.

How PSUR Management Works

PSUR management in Vault 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 Veeva 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:

Navigate to the list of Periodic Report Templates (periodic_report_template__v), and click to create a new Periodic Report Template record.
Add the name of the template and provide the required metadata (Product, Country, and so on).
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.
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:

Navigate to a PSUR Template record of the PSUR object type, either in Business Admin or in a custom object tab, per your configuration.
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 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.

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: