Document QC & Auto Link Verification — Catch It Before It Reaches the Sequence
Quality Checks That Run Before Anyone Has to Ask
Every document checked against your rules when it is uploaded, mechanical problems fixed in a new version, approval gated on the result — and every hyperlink verified against where it actually lands.
Most submission defects are mechanical — and found too late
Missing Fast Web View, bookmarks that change the zoom, author names left in the metadata, a file type the agency does not accept in that section, a link that opens the right document on the wrong page. None of these is hard to fix. All of them are expensive to find during final publishing.
DnXT checks documents where they are created and approved, fixes what can safely be fixed, and verifies links by rule rather than by eye.
Built for the people who own the outcome
Regulatory operations
Stop catching mechanical PDF issues during final publishing, when every fix costs a re-render and a re-check.
Document owners and authors
See exactly what failed and why, and get a corrected version with one action where the fix is mechanical.
Quality and compliance
Decide whether QC findings inform or block approval, and see every override with its reason in the audit trail.
Checks, fixes and gates across the platform
Configurable QC
Word and PDF checks with on/off, severity and limits set per company and region by an administrator — not one fixed list for everyone.
Auto-fix in a new version
Opening view, collapsed bookmarks, inherited zoom, cleared author metadata and Fast Web View are fixed and checked in as a new version. Each fix is re-checked; anything that still fails is reported as skipped, never as fixed.
Inform or block
Per company: QC findings either inform, or block approval while a high finding is open or QC has not finished. Authorised users can override with a reason recorded in the audit trail.
Fast Web View without broken checksums
PDFs are optimised for fast web view as they are placed in a sequence, before the checksum is recorded — so the sequence describes the exact file that ships.
Auto Link Verification
Every link is checked once per PDF version: the target is in the submission, the page exists, and the landing page actually contains what the link text says — with the right page suggested when it does not.
Publishing gates
A sequence cannot be published while a document from the eDMS is still a draft, and a US check flags any file type FDA does not accept in that eCTD location.
Rules, not guesses
“QC didn’t run” is never “QC passed”
Where approval is gated, a document whose QC has not completed is treated as not passed.
Link checks are code, not AI
Auto Link Verification uses fixed rules. A reviewer starts from evidence — passed, failed or not checkable — not from a model’s confidence score.
FDA forms are checked as FDA built them
A form is submitted exactly as FDA publishes it, so checks on how FDA built the file are skipped, while checks on the filled form still run.
Compare runs, not reports
Validation history shows what is new since the last run, what was fixed and what is still failing — so re-validation answers “did my edits add anything?” directly.
Frequently asked
Which fixes are automatic?
Opening view, bookmark collapse and zoom, author metadata and Fast Web View. Font embedding is deliberately not offered: a missing font cannot be added without the original font file.
Can we set our own QC rules?
Yes. Administrators set each check’s status, severity and limits, and choose a default region and whether findings inform or block approval.
What does Auto Link Verification check?
That the link’s target is part of the submission, that the destination page exists, and that the text the link claims — a section number, a table or figure, a study ID or a heading — appears where it lands.
Which file formats does the FDA check use?
FDA’s published table of accepted file formats by eCTD location, held as data so an FDA revision is a data update that names its version.
Fix it where it starts.
Send us a document set that gave you trouble at publishing time, and we will show you what DnXT would have caught, fixed and flagged.
