Equipment Qualification Report

1. What this module does

You list the user requirements and the tests at each stage with their acceptance criteria and results. The tool checks each result, builds the traceability matrix and shows which requirements are verified.

It also checks deviations, procedures, training, calibration and computerised-system functions before the equipment is released for use.

What you get

• A Word or PDF report: Equipment qualification report (IQ/OQ/PQ).

2. Before you start

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

• The user requirement specification with critical requirements marked.
• IQ, OQ and PQ tests with acceptance criteria and results.
• Deviations and their status.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/equipment-qualification.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 equipment

   Enter the equipment, its ID and location, the protocol and report numbers, and choose the regulations.

   

2. Enter requirements and tests

   One row per user requirement. One row per test with its stage (IQ, OQ or PQ), the requirement IDs it verifies, the criterion and the result.

3. Read the result

   The headline says whether every test passed and the equipment can be released: "11 tests passed · released for GMP use".

   

4. Resolve alerts and download

   A failed test is critical. Requirements with no test, open deviations, missing stages and missing calibration or training 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 · Equipment

2 · Requirements and tests

Requirements: one row each, critical yes or no. Tests: stage (IQ, OQ, PQ), the requirement IDs it covers (";"), the criterion and the result. A result can be a number, pass or fail.

3 · Release for use

5. Checks and alerts

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

• Each result against its acceptance criterion.
• Every requirement verified by at least one test.
• IQ, OQ and PQ present; deviations closed; calibration, procedures and training in place.

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 follows 21 CFR 211.63 and 211.68. EU follows EU GMP Annex 15 (and Annex 11 for computerised functions). ASTM E2500 gives a risk-based approach.

8. Working with other modules

• Qualified equipment is referenced in the Process Validation Report and the Facilities & Equipment Writer section.

9. Common pitfalls

• Tests that do not trace to a requirement, or requirements nobody tested.
• Releasing the equipment with a deviation still open.

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. Fail an OQ test

   Change the turret speed result at 20 rpm from 20.3 to 23.1.

   Expected resultThe headline shows one test failed.