Skip to main content

PSUR Configuration

The Periodic Safety Update Report (PSUR) is a critical compliance document. DataReality allows Company Administrators to define standard templates, AI prompts, and abbreviation lists that enforce consistency across all reports generated by your organization.

1. Configuration Library​

Navigate to Company Settings > PSUR Config. This central repository lists all report templates available to your team.

PSUR Configurations List
  • Status:
    • PUBLISHED: Available for use in new reports.
    • DRAFT: Work-in-progress; only visible to admins.
  • Business Segment: categorizes templates (e.g., "Vision Care", "Medical Devices") to organize large portfolios.
  • Actions: Edit or Delete configurations directly from this list.

2. Creating a Configuration​

Click + Create Configuration to start a new template definition.

New PSUR Configuration

General Settings​

  • Configuration Name: A recognizable title (e.g., "EU-MDR Annual Template").
  • Description: Guidelines for when this specific config should be used.

3. Editing a Configuration​

The editor is divided into four functional tabs, allowing granular control over every aspect of report generation.

Edit General Settings

A. AI Prompts​

This is the core implementation of DataReality's Generative AI. You define the system prompts that guide the AI in synthesizing safety data.

AI Prompts Tab
  • Prompt Library: Select a section (e.g., "Complaint Rate Summary", "Patient Exposure").
  • System Prompt Template: Enter the instructions.
    • Example: "Summarize the complaint rate trends for the last 12 months, highlighting any deviations > 5%."
    • Variables: Use dynamic placeholders like {{product_name}} or {{date_range}} to make prompts reusable.

B. Abbreviations & Acronyms​

Standardize terminology across all documents. DataReality will automatically expand these acronyms on their first occurrence in the text, ensuring readability and compliance without manual proofreading.

Abbreviations Tab

C. Branding & Styling​

Customize the visual identity of your generated reports. This ensures that every PDF exported from DataReality aligns with your corporate branding guidelines.

Branding & Styling Tab

Brand Assets​

  • Logo Source: Choose between the default Company Logo (defined in global settings) or upload a Custom PSUR Logo specific to this report type.
  • Logo Configuration:
    • Dimensions: Fine-tune the Width and Height sliders (in pixels) to ensure the logo renders clearly without distortion.
    • Placement: Align the logo (Left, Center, Right) to match your document header standards.
    • Spacing: Adjust the Spacing Before (in points) to control the vertical whitespace between the page margin and the logo.
Validation

Changes to a Published configuration propagate immediately. For major updates, we recommend creating a new DRAFT version first, validating it on a sample report, and then swapping the PUBLISHED status.