Extract
The model reads.
It extracts cited facts from R&D, QC, QA, and prior filings. A fact without a document, a page, and a span is not an answer. High-precision retrieval is the job. Judgment is not.
Rauzr How it works
How it works
Agents do the work. Humans review.
Every Rauzr agent is built for regulated review: retrieval that cites the page, rules that do not drift, and a person on every decision. Rules find the issue; anyone can verify it by asking and reading the source. The examples below come from Dossiq, the first Rauzr Helix agent.
Separation
Each kind of work has an owner.
Rules
The check is deterministic.
Rules compare those facts: a specification against a method, a stability conclusion against the data, impurity wording against the release text. The same inputs produce the same result. The rule id is stored on the finding.
Regulatory affairs
The person disposes.
Findings show a source of Rule or Human. Severity, owner, and state are explicit. Agree, dispute, waive with a justification, or raise a finding the agent did not. That record is the disposition.
Who is allowed to do what.
Ask is a reader. It is listed here because teams should see its limits next to the rules, not in a footnote.
| Work | Model | Rules | Ask | Regulatory affairs |
|---|---|---|---|---|
| Read source documents | Yes, and cite | Use stored facts | Yes, and cite | Reviews the source |
| Pass or fail a check | Never | Deterministic result | Never | Disposes the finding |
| Open a finding | Only via a rule result | When a check fails | Never | Can raise a human finding |
| Set severity | Never | From the rule | Never | Can set it on a human finding |
| Waive a finding | Never | Never | Never | With a justification logged |
| Submit to an agency | Never | Never | Never | Outside Dossiq, by a person |
On a small screen, scroll the table horizontally.
Ask
A reader with the limits printed on it.
Ask the package and Ask on a document answer from cited sources only. Scope can be the whole package, one department, one batch, or one file. Voice is an input mode. It is not a second authority.
The interface states the guardrail in the thread: answers cite source documents only, and pass or fail comes from rules and RA review. A question about whether the package is ready to file is refused, and the reviewer is pointed to readiness gates and Review & Approve.
Ask does not create a finding, assign severity, or dispose a package. When a person wants that, the handoff is Raise finding or a side-by-side comparison.
Baselines
A cross-check is only as strong as its baseline.
Sections carry a trust tier so a carried paragraph is not treated as a checked one. The tier is shown on the package. It is a label on the baseline, not a score for the company.
T0
Carried, unverified. A section brought forward without a source check. The product shows it as carried and unverified. It does not show it as cross-checked.
T1
Source document. A baseline from an ingested source. In the product, Tier 1 records how it was established — for example a guided export of an approved sequence — and that the sequence was ingested.
T2
The next tier on the same scale. Where a baseline is marked T2, the package shows that label with the section. The tier is still a description of the baseline. It is not a waiver, and it is not a filing decision.
Record
Attribution you can walk back through.
Regulated teams need to reconstruct who saw a document, which rule ran, and who disposed a finding. Dossiq is designed with that posture: attributable reads, named rule runs, citations that point at a page, and waivers that require a justification.
That is a 21 CFR Part 11 and GxP posture — controls aimed at attribution, audit, and the integrity of the review record. It is a design aim. It is not a certification, and it does not replace validation inside your quality system. What your organization relies on is still your validation, your SOPs, and your disposition.
Limits
What we will tell you plainly.
- Dossiq is not FDA-approved, cleared, or authorized. It is software for the people who prepare a filing.
- Dossiq does not file, transmit, or correspond with FDA, EMA, or any other agency. There is no autonomous submission.
- A Part 11 / GxP posture is not a certificate. Your quality unit decides what is validated and what a record is allowed to support.
- This site publishes no accuracy rates, cycle times, or customer logos. Sample screens are sample screens.
Contact
Bring agents to your regulated work.
Tell us about your team and the work you want agents to take on. We work with health and life sciences teams on regulated, document-heavy work.