Document Review & Authoring Templates — Review Against the Sources, Sign Off With Evidence
Review Against the Sources. Sign Off With Evidence.
Check a document against the documents it was written from, let an AI first pass raise comments a person must answer, bring in external reviewers securely, and complete the review with a signed reconciliation report.
The findings that matter are comparisons
Most of what an experienced reviewer catches is not inside the document under review. It is a disagreement with the source it was written from — a batch size, a specification, a study number that differs from the batch record or the report.
A review tool that only sees the document cannot make those comparisons. And a review that ends in an email saying “looks fine” leaves no record of what was checked.
DnXT links a document to its sources, checks one against the other, and keeps every finding in the same review record until a person closes it.
Built for the people who own the outcome
Regulatory and CMC writers
Get the cross-document discrepancies flagged before review, as comments you can answer.
Reviewers and approvers
Review in one pane with every comment, its disposition and its thread, and sign off on a reconciliation report.
CROs and external experts
Review a sponsor’s document from a secure link with your own identity, without access to anything else.
Review and authoring in one governed place
Check against the sources
Link a document to the documents it was written from, and the numbers in each are compared — so a value that disagrees with its source is raised as a comment on the exact passage.
AI first pass, human verdict
An optional AI pass writes review comments, attributed to the machine, which a person must accept or reject like any other. The person who ran it stays accountable.
Edit in place
Suggested replacement text can be edited and accepted directly in the paragraph, with the change tracked.
External reviewers
Invite a CRO or external expert by secure link with a one-time code. Each grant is its own identity, and a review link cannot reach document content outside the review.
Signed completion
A review completes only when every comment is dispositioned, with an outcome statement, the meaning of the signature and re-authentication, producing a signed reconciliation report.
Governed templates
Authoring templates move from Draft through review to Approved and Retired. Each heading carries guidance on what to write, and a preview shows the document without filing anything.
Why it is built this way
The machine only comments
AI findings enter the same record as human comments and are answered the same way. Nothing an AI produces becomes a decision without a person.
Numbers by rule, meaning by person
Numeric agreement is checked by fixed rules, which do not make arithmetic mistakes. Judgements about meaning stay with reviewers.
One finding, one comment
Discrepancies are identified by the values in conflict, so the same problem is never raised four times under four labels.
A template is a proposal until approved
New templates arrive as Draft, because calling them approved would assert a review nobody performed.
Frequently asked
Is the AI first pass required?
No. It is optional, switched on per company, and its comments are always labelled as machine-written.
How do external reviewers access the document?
Through a secure link with a one-time code sent to their email. Their comments are recorded under their own identity, and the link gives no access beyond the review.
What does completion produce?
A signed reconciliation report listing every comment, its disposition and the outcome, signed with its meaning and the reviewer’s re-authentication.
Can templates carry our own writing guidance?
Yes. Guidance for each heading can be rewritten for your company directly from the template page.
Find the discrepancy before the agency does.
Bring a document and its sources, and we will show you the review DnXT starts with.
