What is a second brain for a quality system?
At Eesti Farmaatsia Grupp (EFG) we use “second brain” for a working copy of an agreed set of your GMP documents and records, kept on a machine at your own site. Fixed checks and local AI flag possible inconsistencies and cite their sources. Your QA team reviews each finding and decides. Your document management system remains the place where documents are approved and controlled.
Where does the idea come from?
We borrow the term from Tiago Forte's books Building a Second Brain (2022) and The PARA Method (2023). His method helps people record and organise information so that they can find it again when they need it.
The first book describes four steps, which he calls CODE: capture information, organise it, distil what matters and use it in your work. The second describes PARA, which groups material by how it will be used: Projects, Areas, Resources and Archives.
Forte's books inspired this approach. EFG adapted it for GMP document review and is not affiliated with Tiago Forte or Forte Labs.
How does Veiko Saluste use his own?
Veiko Saluste has kept his own working notes this way since 2025 and uses them every day. They are plain-text files in folders, and he uses an AI assistant to work with them. Client GMP documents are handled differently: they are checked on a machine at the client's site and are not sent to any cloud service. Three habits from his own work are useful in GMP document review.
| Habit | Why it is needed | How it is used in GMP work |
|---|---|---|
| An answer comes with its source. | A regulatory answer is checked against the official text, and the document, version and clause are recorded. An answer without a source cannot be checked. | A finding names the evidence the reviewer needs to check: document, version, clause and quotation. |
| Corrections are recorded. | When an answer turns out to be wrong, the correction is written down and read again when later work starts. | Agreed corrections are recorded, and recurring errors are added to the repeat test. This does not replace CAPA, where the cause is investigated and the effectiveness of the action is checked. |
| The working copy is reviewed regularly. | Once a week the notes are reviewed. Outdated statements are corrected, and what is no longer current is moved to the archive. | Outdated references are updated, and current versions are kept apart from earlier ones. |
The main work is not writing things down. It is keeping references current and checking that related documents still agree. He learned the same from the quality systems of the plants he built. Why he does this →
What does it look like in a quality system?
This is our own view, not a GMP requirement. The four groups can help people find their way in a quality system, because they sort material by the task it is needed for. They are working views: the same CAPA record can be open work, belong to a standing process and later be kept as history.
| Group | In the books | In a quality system |
|---|---|---|
| Projects | Work with an end and a deadline. | An open change, a CAPA, a validation project, the preparation for an inspection. The official record and its status stay in your quality system. |
| Areas | Responsibilities with no end date. | Standing responsibilities, for example document control, training and supplier qualification. Each has a named owner. |
| Resources | Reference material. | The GMP texts and guidelines you work to, each with its version and date, so that a text in force, a draft and an earlier version can be told apart. |
| Archives | What is finished or no longer current. | Earlier document versions and the records of completed work. They are kept under the applicable retention requirements, remain retrievable and are kept apart from current material. Your official archive stays in your own system. |
The second brain is this working copy, structured so that documents can be compared with each other and with GMP text. It does not decide which version is in force. Your document management system does.
What is it used for?
One example. When an SOP changes, the fixed checks and local AI go through the agreed documents again and flag the forms, specifications and training records that still carry the old limit or refer to the old version. Your QA team checks each flag against the documents and decides.
We have published test results for cross-reference checks and for comparison with selected GMP clauses, together with what was missed: test 1 and test 2. The tests used invented documents. A full comparison of an old and a new version of a GMP chapter has not been tested yet. What the service covers, and what has been tested for each part →
Where are the limits?
- 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. It flags possible findings and cites the source. Your QA team decides what action to take.
- For continuous use, the agreed test is repeated every quarter and before an approved change goes live.
Where do you start?
With a review of your GMP documents: two days at your site, for a list of documents agreed in advance. The review stands on its own and helps you decide whether continuous checks would be useful. See what the two-day review covers → · Contact →