Overview #
PDF Rendering Configuration in DnXT Administrator provides comprehensive tools for managing how PDF documents are generated, validated, and certified for regulatory submission. Regulatory authorities worldwide impose strict technical requirements on PDFs included in eCTD submissions — from PDF version and font embedding to bookmarks, hyperlinks, and security settings. The PDF Rendering module ensures your documents meet these requirements before they are included in a submission.
This module is organized into three tabs: Profiles (rendering configurations per region), Compliance Rules (the validation rules applied to PDFs), and Validate PDF (test a specific file against a profile).
Accessing PDF Rendering Configuration #
- Log in to DnXT Administrator.
- Click PDF Rendering in the left sidebar (or navigate to Configurations > PDF Rendering).
- The PDF Rendering view opens with three tabs: Profiles, Compliance Rules, and Validate PDF.
Profiles Tab #
The Profiles tab manages PDF rendering profiles — named configurations that define how PDFs should be generated and what standards they must meet. Each profile targets a specific regulatory region and PDF specification.
Profiles Table #
The profiles table displays all configured profiles with the following columns:
| Column | Description |
|---|---|
| Name | The display name of the profile (e.g., “FDA Standard”, “EMA Compliant”) |
| Slug | A URL-friendly identifier used internally |
| Region | The target regulatory region |
| PDF Version | The PDF specification version |
| System | Whether the profile is a system-provided default or user-created |
| Actions | Edit, Clone, Delete buttons |
Creating a New Profile #
- Click the Add button in the toolbar.
- Fill in the profile fields:
| Field | Description | Options |
|---|---|---|
| Name | Display name for the profile | Free text |
| Slug | Unique identifier (auto-generated from name) | Lowercase, hyphens |
| Description | Describe the profile’s purpose | Free text |
| Region | Target regulatory authority | FDA, EMA, PMDA, Health Canada, Internal |
| PDF Version | PDF specification version | 1.4, 1.5, 1.6, 1.7 |
| Compression | Enable PDF compression | Enabled/Disabled |
| Fast Web View | Enable linearization for faster web loading | Enabled/Disabled |
| Tagged PDF | Enable PDF tagging for accessibility | Enabled/Disabled |
- Click Save.
Cloning a Profile #
To create a new profile based on an existing one:
- Find the profile in the table.
- Click the Clone button in the Actions column.
- A copy of the profile is created with “(Copy)” appended to the name.
- Edit the cloned profile to customize it for your needs.
Region-Specific Requirements #
Different regulatory authorities have different PDF requirements:
| Region | Typical PDF Version | Key Requirements |
|---|---|---|
| FDA | 1.4 – 1.7 | Embedded fonts, bookmarks, no password security, 8.5″ x 11″ preferred |
| EMA | 1.4 – 1.7 | Embedded fonts, A4 format, no multimedia, tagged PDF recommended |
| PMDA | 1.4 – 1.6 | Embedded fonts, bookmarks, A4 format, specific margin requirements |
| Health Canada | 1.4 – 1.7 | Embedded fonts, bookmarks, no security restrictions, letter or A4 size |
| Internal | Any | Custom requirements for internal use — not destined for regulatory filing |
Compliance Rules Tab #
The Compliance Rules tab displays all PDF validation rules that DnXT checks during PDF validation. Rules are predefined by the system and cover the full spectrum of PDF technical requirements for regulatory submissions.
Category Filter #
Use the category filter to narrow the rules list by type:
| Category | Description | Example Rules |
|---|---|---|
| Structure | PDF file structure and format compliance | PDF version check, file header validation |
| Font | Font embedding and usage | All fonts embedded, no Type 3 fonts, character encoding |
| Bookmark | Bookmark structure and validity | Bookmarks present, valid bookmark destinations |
| Link | Hyperlink validity and behavior | No broken links, valid URL formats, proper link annotations |
| Metadata | PDF metadata fields | Title present, author present, creation date set |
| Security | Security and permission settings | No password protection, no encryption, content copying allowed |
| Page | Page layout and dimensions | Page size within limits, consistent orientation, proper margins |
| Content | Document content requirements | No embedded multimedia, no JavaScript, no form fields |
Rules Table #
Each compliance rule displays the following information:
| Column | Description |
|---|---|
| Code | A unique rule identifier (e.g., FONT-001, LINK-003) |
| Name | A human-readable rule name |
| Category | The rule category (Structure, Font, Bookmark, etc.) |
| Severity | Error (must fix), Warning (should fix), or Info (advisory) |
| Auto-Fix | Whether DnXT can automatically fix this issue during rendering |
| Description | A detailed description of what the rule checks |
Validate PDF Tab #
The Validate PDF tab provides an on-demand PDF validation tool. Use it to check any PDF file against a specific rendering profile before including it in a submission.
Running a Validation #
- Navigate to PDF Rendering > Validate PDF.
- Select a Profile from the dropdown (determines which compliance rules are applied).
- Enter the File Path of the PDF to validate (the path must be accessible from the DnXT server).
- Select the Source Type (e.g., repository file, uploaded file).
- Click Validate.
Validation Results #
After validation completes, the results are displayed in two sections:
Summary #
A high-level overview showing:
- Total number of rules checked
- Number of Errors (red) — issues that must be fixed
- Number of Warnings (yellow) — issues that should be reviewed
- Number of Info (blue) — informational messages
- Overall Pass/Fail status
Detail Table #
A detailed table listing every rule that was checked, its result (Pass, Fail, Warning), and a description of any issues found. Failed rules include specific information about what was wrong and how to fix it.
Common PDF Issues and Resolutions #
| Issue | Category | Resolution |
|---|---|---|
| Fonts not embedded | Font | Re-render the PDF with font embedding enabled (Auto-Fix available) |
| No bookmarks | Bookmark | Add bookmarks in the source document or use DnXT’s bookmark generation |
| Password protected | Security | Remove password protection from the source document |
| Incorrect PDF version | Structure | Re-save the PDF using the correct version (Auto-Fix available) |
| Embedded multimedia | Content | Remove audio/video content; replace with static images |
| JavaScript present | Content | Remove JavaScript; re-export from the source application |
| Broken hyperlinks | Link | Fix or remove broken links in the source document |
FAQ #
Which PDF version should I use? #
Most regulatory authorities accept PDF versions 1.4 through 1.7. PDF 1.4 has the broadest compatibility and is the safest choice if you are unsure. Check the latest guidance from your target authority for specific requirements.
Can DnXT convert Word documents to compliant PDFs? #
Yes. DnXT’s rendering engine can convert documents to PDF format using the configured profile settings. The rendered PDF will have fonts embedded, correct version, and other profile-specified properties applied automatically.
What does “Fast Web View” mean? #
Fast Web View (linearization) restructures the PDF so that it can begin displaying before the entire file is downloaded. This is a “nice to have” for web-based submission portals but is not required by most authorities.
Can I create custom compliance rules? #
The compliance rules are system-defined and cover industry-standard requirements. Custom rules cannot be added through the UI. If you need additional validation checks, contact DnXT Solutions to discuss custom rule development.
How often should I validate PDFs? #
Validate PDFs when they are first added to a submission and again before final publishing. If a document is updated or re-rendered, validate the new version. Establishing a validation step in your workflow (using the Workflow Manager) ensures this happens consistently.
