Preflight Validation — Each Region’s Criteria, While You Build


Validation

Validation that runs while you build

The target region’s own criteria, graded at that region’s severity, run on the sequence as it is assembled — with document checks as files arrive and a history you can compare run against run.

Validation report
Sequence 0007 — US
Graded at FDA severity
Sub-type not valid for submission typeEnvelope
High
File changed after backbone was builtm3/32p/stability.pdf
High
Hyperlink target not foundClinical summary, page 14
Medium
Bookmarks missingcsr-001.pdf
Low
Two high-severity findings: this sequence would be rejected.
The problem

A clean report only means something at the agency’s severity

The same defect can be a warning in one region and a rejection in another. A generic checker that grades everything the same way — or one run only on the last day — tells you little about whether the sequence will be accepted.

DnXT applies the receiving region’s own criteria and grading, from the first draft of the sequence.

Who it is for

Built for the people who own the outcome

Publishers

Fix findings while the sequence is being built, in order of severity.

Regulatory operations leads

See validation history for each sequence and what changed between runs.

Quality

Keep the validation report that was produced at the point of publishing with the sequence.

How it works

Getting a sequence through cleanly

Choose the scope

Validate the whole sequence or the part you changed.

Read by severity

Rejection-level findings first, then the rest.

Fix at the source

Envelope, lifecycle, titles and file names; mechanical PDF problems fixed in a new version.

Re-run and compare

Compare with earlier runs to confirm what was fixed.

Capabilities

What is checked

Regional criteria

More than 2,500 criteria across 16 regions, each with the region’s own severity.

Envelope and identifiers

Application numbers, submission types and sub-types, sequence numbers and their folders.

Backbone and specification files

Backbone against the region’s DTD or schema, checksums, and the required specification files.

Lifecycle

Operations that point at documents that do not exist or sit in another section.

Documents

PDF version and security, fonts, bookmarks, Fast Web View, file names and paths.

Hyperlinks

Every link checked against its destination, not only for whether the file exists.

Questions

Frequently asked

When should validation run?

From the first draft of the sequence, and every time it changes — not only before transmission.

Does DnXT fix problems automatically?

Mechanical document problems that can safely be fixed are corrected in a new version for a person to accept. Envelope and lifecycle findings are fixed by the publisher.

Validate a sequence of your own

Bring a sequence and we will run its region’s criteria in DnXT with you.