Module 3 Authoring Tool
Drafts Module 3 sections from source documents and cites every sentence to the table or section it came from.
Interactive walkthroughThis is a scripted walkthrough with synthetic data. It shows how the tool works without real program data.
Source
STB-RPT-014 · Drug product stability report
Three commercial-scale batches · long-term storage at 5 °C ± 3 °C · Table 3 shows batch DP-001
| Test | 0 mo | 6 mo | 12 mo |
|---|---|---|---|
| Potency (%)Spec 80 to 125 | 101 | 99 | 98 |
| Purity, SEC (%)Spec ≥ 95.0 | 98.9 | 98.6 | 98.4 |
| AppearanceSpec Clear, colorless | Conforms | Conforms | Conforms |
| pHSpec 6.8 to 7.6 | 7.2 | 7.2 | 7.3 |
Drafted section
Click a sentence to see the source rows that support it.
The draft does not state a 24-month shelf life. The source set has no 18-month or 24-month results. Thus the tool flags the claim and does not write it.
Why I built it
Each Module 3 writing cycle had the same problem. Batch records, stability reports, analytical methods, reviewer comments, and gap closure were in separate places.
This tool started from my work at Novavax. See the role →
What it does
- Links source files directly to the draft text.
- Shows support gaps before the late-stage review.
- Gives output that is ready for review, not raw generated text.
- Keeps the traceability as the content moves to the submission pack.
- What goes in
- Batch records, stability reports, analytical methods, templates, document plans, and the expected section structure.
- What comes out
- Draft sections, citation maps, Word-ready exports, review notes, and gap summaries for reviewers.
- What it changes
- Teams spend more effort on scientific quality and less effort on repetitive draft work. The traceability stays intact.
How it stays inside the rules
- What it is for
- The tool writes first drafts of Module 3 sections from named source documents, and it flags gaps. The users are a regulatory writer or a CMC author. The output is a draft with citations. It is never filed content.
- What it never does
- This tool is outside the boundary of critical GMP applications, because it does not control a process or release product. But the output becomes submission content. Thus ALCOA+ and 21 CFR Part 11 expectations apply from the first draft. They apply to version control, attribution, and the audit trail.
- Who decides
- Each sentence that the tool writes has a citation to its source document and page. The writer checks each claim against its source before the claim goes into the document plan. The tool blocks each unsupported statement and does not make it softer.
- Risk level
- High under FDA's draft AI framework (how much the output influences a decision × how serious that decision is)
- Guidance it follows
- FDA draft guidance · ICH M4Q(R2) · EU GMP Annex 22
What already exists
- Docuvera: Structured authoring of modular, reusable, and traceable CMC content components
- Celegence CAPTIS: Generative AI that automates the creation of CMC Module 3 documents
- Certara CoAuthor: Generative AI for regulatory and medical writing, now integrated with Veeva RIM data flows
- Weave Bio, SyncIQ, Peer AI, DDi REGai: New AI authoring platforms that make the Module 3 drafting workflow shorter
- The gap it targets
- Many vendors focus on drafting speed. My focus is narrower: source traceability, and the restructure decision under ICH M4Q(R2), which is still a draft. The draft turns Module 3.2 into a data repository on a standard template: Description, Manufacture, Control, and Storage. The question is which existing 3.2.S and 3.2.P content goes where, and which cross-references to Module 2.3 break when the content moves.
- What it is not
- It is not a better writer than a regulatory writer. It finds and cites source evidence, and it flags what is missing. Thus the writer uses the time for judgement, not to find documents.
Do you build tools like this?
I am glad to compare notes: what worked, what a reviewer did not accept, and where AI should stay out of the decision.