Self-Inspection Report

1. What this module does

You enter the audits performed and the findings with their CAPA, owner, due date and status. The tool maps each audit to a GMP area and checks every area was audited within the cycle.

It flags critical findings, overdue CAPAs, findings without owners and findings that repeat earlier ones.

What you get

• A Word or PDF report: Self-inspection report.

2. Before you start

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

• The audits performed in the cycle.
• Findings with CAPA, owner and due date.
• Findings from earlier self-inspections.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/self-inspection.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 programme

   Enter the site, the cycle length and the report date.

   

2. Enter audits and findings

   One row per audit and per finding. Paste earlier findings one per line to check for repeats.

3. Read the result

   The headline gives the outcome: "All 10 areas audited · 6 findings".

   

4. Resolve alerts and download

   Critical findings, areas not audited, overdue CAPAs and repeat findings 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 · Programme

2 · Audits performed

3 · Findings

5. Checks and alerts

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

• Every GMP area within the cycle.
• Findings by class with CAPA, owner and due date.
• Overdue and repeat findings; management review.

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

EU follows EU GMP Chapter 9. US expectations follow ICH Q10 and the quality unit responsibilities in 21 CFR 211.22.

8. Working with other modules

• Supplier audits are reported in Supplier Qualification Report.

9. Common pitfalls

• Areas skipped year after year.
• Auditors auditing their own area.

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. Miss an area

   Move the storage and distribution audit to June 2025, outside the cycle.

   Expected resultThe headline shows one GMP area not audited in the cycle.