Method Transfer Report

1. What this module does

You enter the acceptance criteria from the protocol (maximum difference of means and maximum %RSD for each test) and the replicate results of both laboratories for each batch and analyst.

For each test and batch the tool calculates the means, the difference (relative or absolute), each laboratory's %RSD and the 90% confidence interval of the difference, and decides whether the receiving laboratory is qualified.

What you get

• A Word or PDF report: Analytical method transfer report, with criteria, results, discussion and sign-off.

2. Before you start

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

• The approved transfer protocol and its criteria.
• Both laboratories' replicate results for each test and batch.
• Training, instrument qualification and gap analysis records.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/method-transfer.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 transfer

   Enter the procedure, the sending and receiving units and the approach (comparative testing, co-validation, revalidation or waiver). For a waiver, give the justification.

   

2. Enter criteria and results

   One criteria row per test, with rel (% of the sending mean) or abs (absolute) difference. One result row per test, laboratory (SU or RU), batch and analyst, with the replicates separated by ";".

3. Read the result

   The headline says whether the receiving laboratory is qualified: "4 comparisons · receiving laboratory qualified". The table shows each difference with its 90% confidence interval.

   

4. Resolve alerts and download

   A difference or %RSD outside the criteria is critical. Results from one laboratory only, tests not done, a single analyst and undocumented prerequisites 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 · Transfer

2 · Acceptance criteria

One row per test, from the approved protocol. Difference type: rel (% of the sending mean) or abs (absolute, in the result unit).

3 · Results

One row per test, laboratory (SU or RU), batch and analyst. Put the replicate results in one cell separated by ";".

5. Checks and alerts

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

• Difference of means within the limit and %RSD within the limit in each laboratory; a failure is critical.
• 90% confidence interval of the difference (Welch) within ±limit (equivalence); a wide interval is noted.
• Both laboratories tested every sample; every test in the criteria was done; two receiving analysts where needed.
• Prerequisites (training, qualification, gap analysis) and system suitability.

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: Results and 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 follows USP <1224> and section VIII of the FDA guidance on analytical procedures and methods validation (2015). EU follows EU GMP Chapter 6 (6.37–6.41) on technical transfer of testing methods.

8. Working with other modules

• Write the protocol in the Protocol Builder (Analytical method transfer).
• The procedure's validation is in the Method Validation Studio.

9. Common pitfalls

• Comparing different samples in each laboratory.
• Setting the criteria after seeing the results.

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. Introduce a bias in the receiving laboratory

   Change the receiving results for batch B2402 to 98.1;98.4;98.3.

   Expected resultThe headline shows one comparison outside criteria.