GMP document review first. Then a second brain for your quality system.
The first step is a review of your GMP documents at your site. It stands on its own. If it proves useful, we help you turn it into a second brain for your quality system: a knowledge base on a machine at your own site that local AI can read. It checks cross-references and compares your procedures with new GMP texts; for these two we have published test results. Drafting the Product Quality Review and reminders of planned work are built and tested together with you. It does not replace your daily quality work, and your qualified people make every decision.
What it does
| Task | What you get | Evidence today | Decided by |
|---|---|---|---|
| Cross-references | References that point to a missing, retired or changed document, and limits, roles and deadlines that differ between documents. | Tested on a synthetic document set (test 1, test 2). | Document owner, QA |
| New GMP texts | When a chapter or annex changes, your procedures compared with the new text clause by clause, with the passages that may no longer agree. | Selected clauses compared on a synthetic document set (test 2). A full comparison of an old and a new version has not been tested yet. | QA, through change control |
| Product Quality Review | A draft review compiled from your batch, deviation, change, complaint and stability records, every figure traceable to its source record (EU GMP 1.10). | No published test yet. Built and tested on your records, against acceptance criteria agreed in advance. | QA verifies every figure. Evaluation and approval follow your own PQR procedure (EU GMP 1.11). |
| Planned work | Reminders when periodic document reviews (EU GMP 4.5), self-inspections (Chapter 9), supplier audits, requalification (Annex 15) and training (2.11) fall due. Fixed rules, no AI. | No published test yet. Built with you. | The owner of each task |
What it is not
- It does not replace your document management system, your QA team or the Qualified Person.
- It does not approve documents, close deviations or release batches.
- A finding or a draft is a suggestion until a qualified person has checked it against the source.
Where the idea comes from
We borrow the term “second brain” from Tiago Forte's books Building a Second Brain (2022) and The PARA Method (2023) and adapted his approach for GMP document review. We are not affiliated with Tiago Forte or Forte Labs. What a second brain is, and how Veiko Saluste uses his own →
How we build it with you
Step 1: review. Two days at your site, for a list of documents agreed in advance. We review them on our own machine: cross-references, and limits, roles and deadlines that differ between documents. The two days include a four-hour training session for your team. On the afternoon of the second day you receive the finding report (sample report) with a plan for putting the system right, and you sign for its receipt. Your QA decides on each finding afterwards, and you have ten working days to send us comments on the report. This step stands on its own, and you can stop here. What you prepare, and what happens to your documents →
Step 2: build. Together with your QA we structure the documents and records, configure a Mac Studio that you own, write the fixed rules and test the system on your own documents with a set of known errors, before anyone relies on it. Your team learns to check every output.
Step 3: keep it right. Once a quarter we check that the system works and run the test again, at your site or, if you prefer, by remote connection. The first repeat test comes three months after installation. The local AI, the rules and the settings are changed only with your QA's approval: the test is repeated before the new version is used, and the previous version is kept so that it can be restored. Who keeps the rules and the regulation texts up to date is agreed in the contract. The machine, the data and the configuration are yours, with written documentation, so the system does not depend on us being available.
What is proven today
Cross-reference checking and comparison with EU GMP text have been tested on a synthetic quality system. The results are published together with what was missed: test 1 and test 2.
The Product Quality Review draft and the reminders are built and tested on your own records in step 2. We will publish demonstration results for them when they have been run.
Where it runs, and your data
The system runs on a dedicated machine at your site and works without an internet connection. Your documents are not sent to any cloud service. Running locally tells you where the data is processed; it does not by itself prove security or GMP suitability, which are shown separately. What happens to your documents →
Where this stands in GMP
- In force: EU GMP Chapter 4 and Annex 11 apply to your documents and computerised systems today.
- Draft: Annex 22 on artificial intelligence was published for consultation in July 2025 and was still a draft when we checked on 15 November 2026. The consultation draft says that generative AI should not be used in critical GMP applications. Draft Annex 22 in plain words →
- Our view: these tasks are support work in which a qualified person checks each output against its source and makes the decision. Before any use we assess with your QA team how critical it is, including what happens if the system misses something.
Start with a conversation
Tell us the type of manufacturing, roughly how many GMP documents you have and when your next inspection is expected. A first call takes 30 minutes. Contact →