An inspector writes one paragraph.

Answering it will take your quality team three weeks, and the answer has to survive being read back to you.

Observation — illustrative

Written procedures for sampling are not consistently followed, and the records do not show the step was witnessed by a second analyst.

Fictional text. Not from any real inspection, company or product.

• Root cause · BR-2291The step was performed but not witnessed — the batch record has no field for it
• Correction · SOP-QC-014Analysts re-trained, the four Q3 batches re-reviewed
• Preventive · DEV-0471A witness signature field added, and tracked in the deviation log

Every paragraph carries the record it rests on.

Not a model's recollection of a document. The document.

Nothing is filed until QA signs.

In a GMP environment a wrong answer is worse than no answer, so the system drafts and a qualified person decides.