Technology Transfer Report

1. What this module does

You track the transfer package items, compare process parameters and equipment between sites, and enter the receiving-site results for each quality attribute with the sending-site historical range.

The tool flags open items, unjustified differences and results outside the sending-site range or the specification.

What you get

• A Word or PDF report: Technology transfer report.

2. Before you start

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

• The transfer package items and their status.
• Process parameters and equipment at each site.
• Sending-site historical ranges and receiving-site batch results.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/technology-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 product, the sending and receiving sites, the batches and the regulatory filings.

   

2. Enter items, process and attributes

   One row per transfer item, per process difference and per quality attribute. Separate batch results with ";".

3. Read the result

   The headline says whether the transfer is complete: "Transfer complete · receiving site equivalent".

   

4. Resolve alerts and download

   A result outside the specification is critical; outside the sending-site range is major. Open items, unjustified differences and missing analytical transfer 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 · Knowledge transfer

3 · Process comparison

4 · Batch comparison

One row per quality attribute. Sending-site range from historical batches; receiving-site results separated by ";".

5. Checks and alerts

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

• Transfer items complete.
• Process and equipment differences justified.
• Receiving-site results within the sending-site range and the specification.

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: Summary 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: a new site is usually a prior approval supplement (21 CFR 314.70(b)). EU: a variation under Regulation 1234/2008. ICH Q10 and WHO TRS 1044 Annex 4 describe the transfer.

8. Working with other modules

• Analytical methods move with the Method Transfer Report report; the filing is prepared in Post-approval Filings.

9. Common pitfalls

• Comparing only with the specification, not with the sending-site history.
• Equipment differences with no data behind the justification.

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. Shift a dissolution result

   Change the second receiving-site dissolution result from 90 to 84.

   Expected resultThe headline shows one attribute outside the sending-site range.