Shipping Validation Report

1. What this module does

You enter each shipment with its lane, season, load, logger position, duration and the minimum and maximum temperatures. The tool groups shipments into configurations and checks each has enough successful shipments.

Excursions are compared with the time outside the range that your stability data supports. Freezing fails a shipment when the product must not freeze.

What you get

• A Word or PDF report: Shipping validation report.

2. Before you start

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

• The labelled range and the excursion budget from stability data.
• Logger data for each shipment.
• Mechanical stress and product testing results.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/shipping-validation.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 shipper

   Enter the product, the shipper and its rating, the labelled range and the excursion budget.

   

2. Enter shipments

   One row per shipment and logger, with the lane, season (summer or winter) and load (min or max).

3. Read the result

   The headline says how many lanes are qualified: "1 lane qualified · 12 shipments".

   

4. Resolve alerts and download

   A shipment beyond the budget or frozen is critical. Configurations with too few shipments, uncalibrated loggers and missing product testing 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 · Product and shippers

2 · Shipments

One row per shipment and logger. Season: summer or winter. Load: min or max. Time outside: minutes outside the labelled range.

5. Checks and alerts

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

• Each shipment within the range or within the stability budget.
• Summer and winter, minimum and maximum load, with enough shipments each.
• Freeze protection, logger calibration, mechanical stress and product testing.

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

EU follows the EU GDP guidelines (2013/C 343/01) section 9.2. US follows USP <1079> and 21 CFR 211.150. WHO TRS 961 Annex 9 gives the method.

8. Working with other modules

• The excursion budget comes from the Stability Studio or Biologics Stability Studio data.

9. Common pitfalls

• Testing only one season or one load.
• An excursion budget with no stability data behind it.

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. Exceed the budget

   Change the time outside the range for shipment S-03 from 35 to 800 minutes.

   Expected resultThe headline shows one shipment failed.