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.
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 Create Record from Template 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)
- PSUR Data (
- PSUR (
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. |