Quality & Manufacturing
Investigations written from the records they cite.
Investigations, the annual review and the SOP set run on different clocks, so each one gets its own application.
The applications for quality & manufacturing.
Each one is a family of related work rather than a single workflow, built with the specialists who do it.
Investigation Desk
Deviations, OOS, root cause and CAPAs
The batch record is in one system, the test results in another, the interview notes in somebody's inbox. The investigation arrives drafted from the records it cites, with the reasoning recorded while it is still fresh.
See Investigation Desk →
APQR Engine
Annual product quality reviews, built continuously
The annual review gets written from an export that was already stale when it was pulled. It arrives built from current batch, deviation and stability data, stating what moved rather than restating the table.
See APQR Engine →
SOP Studio
SOPs, change control and validation documentation
One process change ripples through forty documents, and somebody has to find all forty. The revised set arrives with every document the change touches already identified.
See SOP Studio →
What arrives.
The documents this function is judged on, authored from your own records and reviewed before your team opens them.
- Deviation and OOS investigations written from the batch record and the test results
- CAPAs with the reasoning recorded at the time, not reconstructed later
- Change control packages
- Annual product quality reviews under 21 CFR 211.180(e), EU GMP Chapter 1 and Schedule M
- Validation protocols and reports
- Complaint and recall investigations
- Supplier qualification files
- Inspection responses where every statement traces to its record
We already read batch records, CoAs and analytical reports to write Module 3, handwritten ones included. Pointing that at an investigation is a blueprint problem.
Start where it hurts.
We'll run it live on a section of your own work.
Request a demoYour data stays in your environment. Customer data never trains foundation models.