Analytical Study Report

1. What this module does

You give the study, the samples, the methods with their status, the reference standards, the results with their acceptance criteria, the system suitability results and any OOS results or deviations.

The tool compares each result with its criterion (a range, a limit or a statement), sets aside the results of a run whose system suitability failed, checks the methods are fit for the purpose of the study, checks the reference standards were in date and needs an investigation reference for each result outside its criterion.

What you get

• A Word or PDF report: analytical study report.

2. Before you start

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

• The approved protocol number and objective.
• The results with their acceptance criteria.
• System suitability results and the raw data location.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/analytical-study-report.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the study

   Enter the report and protocol numbers, the title, the objective and whether the study supports a GMP or regulatory decision.

   

2. Enter samples, methods and results

   One row per sample, method and result. Use the same sample and method IDs in each table so the tool can link them.

3. Read the result

   The headline gives the outcome: "All 13 results meet their criteria".

   

4. Resolve alerts and download

   A result outside its criterion with no investigation and a failed system suitability are critical. Methods that are not validated for a GMP decision, expired standards and a missing raw data location are flagged. Then preview and download.

   

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 · Study

2 · Samples, methods and standards

Method status: validated, compendial (verified), transferred, qualified or not validated.

3 · Results

One row per sample and test. Write the criterion as a range, a limit or a statement; leave it empty for report-only tests.

5. Checks and alerts

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

• Each result against its criterion.
• System suitability, method status and reference standard dates.
• OOS investigations, instruments and raw data.

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: Conclusion. 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

US: 21 CFR 211.194 and the FDA OOS guidance. EU: EU GMP Part I Chapter 6. ICH Q2(R2) applies to both.

8. Working with other modules

• Validate a method first in Method Validation Studio; investigate an OOS result in Investigation Studio (OOS, deviation, CAPA).

9. Common pitfalls

• Reporting the results of a run whose system suitability failed.
• Using a development method for a GMP decision without saying why it is fit for purpose.

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. Report an out-of-specification result

   Change the day-60 water result from 3.6 to 4.4.

   Expected resultThe headline shows a critical issue: the result has no investigation.