GMP quality reports · Training guide
Computerised System Validation Summary
Write the validation summary report for a GxP computerised system: the deliverables expected for its GAMP 5 category, test results and deviations, requirement traceability and the Part 11 / Annex 11 controls.
Open the tool at https://app.cmcfy.com/app/computerised-system-validation.html. This guide is also online at https://cmcfy.com/guides/computerised-system-validation.html
1. What this module does
You choose the GAMP 5 category and GxP impact, list the deliverables with their status, and enter the tests, the requirements they verify and any deviations.
The tool checks every expected deliverable, every test and requirement, open deviations and the data-integrity controls before release.
What you get
- A Word or PDF report: Computerised system validation summary report.
2. Before you start
Have these ready. You can still start with the example data and replace it piece by piece.
- The validation deliverables and their document numbers.
- Test results with the requirement IDs.
- Deviations and the data-integrity control checks.
3. Step by step with the example
Open the tool at app.cmcfy.com/app/computerised-system-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.
Describe the system
Enter the system, choose the GAMP 5 category and the GxP impact, and say whether electronic records or data migration are involved.
Enter deliverables and tests
One row per deliverable, test and deviation. Separate requirement IDs with ";".
Read the result
The headline gives the decision: "Validated · released for GxP use".
Deliverables and tests. Resolve alerts and download
A failed test with no deviation is critical, as is an open deviation at release. Missing deliverables, untested requirements and unverified controls 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 · System
| Field | What to enter |
|---|---|
| System | Type it in. |
| Regulations | Choose one: US: 21 CFR Part 11; EU: EU GMP Annex 11; Both US and EU. |
| GAMP 5 category | Choose one: 3: non-configured product; 4: configured product; 5: custom application. |
| GxP impact | Choose one: High (direct impact on product quality or release data); Medium; Low. |
| Report number | Type it in. |
| Electronic records and signatures used (Part 11 / Annex 11 applies) | Tick the box if it applies. |
| Data migrated from a legacy system | Tick the box if it applies. |
2 · Deliverables
Status: approved, draft or n/a (with a reason).
| Field | What to enter |
|---|---|
| Deliverables | A table. Columns: Deliverable | Document number | Status (approved/draft/n/a). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
3 · Testing
| Field | What to enter |
|---|---|
| Test results | A table. Columns: Test ID | Requirement IDs | Result (pass/fail) | Deviation. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
| Requirement IDs | Write a range such as "URS-01 to URS-10", or list the IDs. Type it in. |
| Deviations | A table. Columns: Deviation | Description | Status (open/closed) | Impact. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
4 · Data integrity controls
| Field | What to enter |
|---|---|
| Audit trail on, secure and reviewed | Tick the box if it applies. |
| Unique user accounts and role-based access | Tick the box if it applies. |
| Electronic signatures linked to records (name, date, meaning) | Tick the box if it applies. |
| Backup and restore tested | Tick the box if it applies. |
| System clock controlled | Tick the box if it applies. |
| Business continuity and disaster recovery | Tick the box if it applies. |
| Periodic review scheduled | Tick the box if it applies. |
| Release decision | Choose one: Released for GxP use; Released with restrictions; Not released. |
5. Checks and alerts
Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:
- Deliverables for the GAMP category.
- Tests, deviations and traceability.
- Audit trail, access, e-signatures, backup and periodic 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
- 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.
- 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).
- Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
- 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.
- 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
| Section | Document |
|---|---|
| Report | Computerised system validation summary report |
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 Part 11 and the FDA data integrity guidance. EU follows EU GMP Annex 11. ISPE GAMP 5 applies to both.
8. Working with other modules
- Equipment with embedded software is qualified in Equipment Qualification Report.
9. Common pitfalls
- Releasing with an open deviation.
- Audit trail configured but never reviewed.
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.
Reopen the deviation
Change the status of DEV-CDS-03 from closed to open.
Expected resultThe headline shows one open test failure or deviation.