QOS Composer & Dossier Assembler

1. What this module does

Each module has a Download summary for QOS button that saves a small .cmcfy.json file with the facts that other sections depend on. The Composer reads those files and writes the QOS from them, so 2.3 always says what Module 3 says.

It also cross-checks the sections: the same impurity limit in the specification and the batch analysis, the same active quantity in 3.2.P.1 and the batch formula, stability batches that appear in the batch analyses, a storage statement that matches light and moisture sensitivity, and summaries made for the same region.

What you get

• Word or PDF files for 2.3 Quality overall summary, 3.2.R Regional information, and a cross-section consistency report.
• An eCTD folder (.zip) with the QOS and your section files placed in the eCTD v3.2.2 structure.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The summary file from each module you have used (.cmcfy.json).
• Proprietary and nonproprietary names, applicant, dosage form and strength, route and proposed indication.
• The eCTD folder names you use for the drug substance and drug product.
• The labelled shelf life and drug substance retest period.
• Regional information: for the US, executed batch records, method validation package and comparability protocols; for the EU, process validation status, CEP or ASMF, TSE certificates and any device (Article 117).
• Optionally, your finished section files to place in the eCTD folders.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/qos-composer.html. The example loads the summaries from every module's example data, so you can see a full cross-check before adding your own files.

1. Enter the product

   Enter the names, applicant, dosage form, route, indication and the eCTD folder names, and choose the region.

   

2. Add the summary files

   Press Add files under Summary files (.cmcfy.json) and pick the summaries saved from each module. Enter the labelled shelf life and retest period. The headline counts the files and the Module 3 sections still missing: 8 summary files, 23 sections still missing, 7 cross-section findings.

   

3. Read the Module 3 coverage

   The coverage table shows every Module 3 section and which module covers it. Missing sections are minor alerts, so you can file in stages.

   

4. Resolve the cross-section findings

   The example has seven major findings, for example the batch analysis using "NMT 0.20%" for the unspecified degradation product while the specification says "NMT 0.3%", and 55.07 mg of active per unit in 3.2.P.1 but 54.8 mg in 3.2.P.3.2. Fix the source module, save its summary again and replace the file here.

   

5. Complete regional information

   Fill the regional panel for the chosen region; it writes 3.2.R. Optionally add your section files: each file name must start with its section number (for example "3.2.P.5.1 Specification.docx") so it lands in the right folder.

6. Preview, download and build the eCTD folder

   Preview 2.3, 3.2.R and the consistency report, read the review and download. The last item builds the eCTD folder (.zip).

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Product (2.3 Introduction)

2 · Summary files from the tools

Each tool has a "Download summary for QOS" button. The example below uses the summaries from every tool's example data.

3 · Regional information (3.2.R)

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• Summary files are present and were made for the same region as this dossier.
• Cross-section consistency: specification criteria against batch analysis criteria, specification tests with batch results, active quantity in 3.2.P.1 against the batch formula, stability batches against batch analyses and stability data, the Q3D status in the specification against the impurity assessment, light and moisture protection against the storage statement, shelf life against stability.
• Every Module 3 section is covered, or listed as still missing.
• Regional information: EU process validation addressed and consistent with the process file; CEP or ASMF status; US method validation package.
• Section files are named with their section number.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: 2.3 Introduction; 2.3.S Drug substance; 2.3.P Drug product. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

The QOS follows ICH M4Q in both regions. In US mode, 3.2.R covers executed batch records, the method validation package and comparability protocols. In EU mode it covers the process validation scheme when validation is not complete, CEPs or ASMFs, TSE certificates and medical devices under Article 117. Summaries made for a different region raise a major alert, because references differ.

8. Working with other modules

• Every module feeds this one: start with Composition & General Info, Process & Controls Writer, Specification Builder, Batch Analysis & CoA, Stability Studio and the others you need.
• Upload sections written outside CMCfy to the Report Reviewer for a gap check before adding them here.

9. Common pitfalls

• Mixing summaries from old and new versions of a module: save the summary again after every change.
• Summaries made for the US in an EU dossier, or the other way round.
• Section files without the section number at the start of the name.
• Treating "not covered yet" as an error: it is a reminder of what is still to write.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Leave EU process validation open

   Set Submission region to EU, then set EU: process validation of the drug product to "Not addressed yet".

   Expected resultA major alert says EU process validation is not addressed.

2. Remove all summary files

   Press Remove all under the summary files.

   Expected resultA major alert says no summary files are added.