From your sources to a cited first draft

Transcript

What the walkthrough shows, step by step

The recording has no narration: it shows the product, with captions. Here is what's on screen, with the time each step starts.

1. 0:00

   Authored documents

   The list of documents drafted and reviewed with Sanai: an IND Module 3, a CAPA investigation, a tech transfer report, a stability summary, a deviation report and a comparability assessment. Create a new authored document.

2. 0:04

   Choose a template

   Choose a template that matches the document type you are authoring: IND Module 3, IND Module 2.3 Quality Overall Summary, CMC stability report or technology transfer protocol.

3. 0:10

   The agent team

   The template selects the agent team that specializes in that document type. Each section is ready to generate from the template.

4. 0:22

   Invite collaborators

   Invite authors and reviewers to collaborate and edit in the same draft, against the same sources.

5. 0:28

   Confirm the input fields

   The user confirms the data in the input fields, such as the dosage form: a cell suspension for intravenous infusion, cryopreserved.

6. 0:40

   Attach the reference documents

   Attach the global source set, the material the document is generated and verified against. Attach everything before generating, so sections cite the right versions.

7. 0:54

   Sources for one section

   A reference can also go to a single section: here the stability protocol is added to Stability Data only.

8. 1:04

   Generate the sections

   From the document outline, generate the sections you choose, such as Stability Data, section 21 of 30.

9. 1:24

   Evaluation agents

   Evaluation agents flag data gaps and compliance risks during generation.

10. 1:28

    The finished draft

    30 of 30 sections generated: Module 3, from the table of contents through the body of data, with unit operations and in-process controls drawn from the batch records.

11. 1:48

    Flagged, never invented

    Missing data is marked in red with the documents searched, so the draft is ready for review.

More videos

Watch the rest of Sanai

• 

  The Sanai film

  1:20

  How Sanai turns raw lab, clean room and clinic data into cited, review-ready regulatory documents: from scattered versions and email threads to a first draft in days.

  Details and transcript→
• 

  Query Engine

  2:05

  A question asked across connected regulatory and clinical documents in Sanai, answered with the sources it came from.

  Details and transcript→
• 

  Review Tool

  0:46

  A drafted document checked claim by claim against its sources in the Sanai Review Tool.

  Details and transcript→
• 

  Document Control

  0:47

  Document versions, changes and their traceability tracked in Sanai Document Control.

  Details and transcript→