Industrial software development
Software supporting industrial activities and compliance: calibration, access control, root cause analysis and predictive maintenance.
Quality & compliance
QualityMind — root cause investigation, amplified
Every deviation has a cause. QualityMind is the reasoning system that hunts for it the way a team of seven expert investigators would — process, instruments, environment, materials, history, regulations — plus one whose only job is to prove the others wrong. The result is an investigation dossier with ranked hypotheses, evidence cited at the source, and contradictions brought to light. The decision stays yours: the system proposes, the Quality team validates.
The problem everyone knows
A root cause investigation of a deviation or OOS can absorb weeks: collecting documents from different systems, correlating them by hand, deadline pressure. And the most insidious risk isn't slowness — it's anchoring: the first plausible hypothesis captures the investigation, alternatives never get truly explored, and the deviation recurs.
Seven specialists, one investigation
Upload the event documentation — batch records, environmental logs, certificates of analysis, maintenance reports — and QualityMind hands it to seven specialized AI agents investigating in parallel: critical process parameters, equipment history, cleanroom data, materials, similar historical cases, regulatory coverage. Each agent forms hypotheses independently and confronts them with its peers', exactly like a well-coordinated investigation team.
The Devil's Advocate
It's the seventh agent, and it works against the other six: it decomposes every hypothesis into verifiable claims and actively searches your documents for the evidence that contradicts them. A hypothesis enters the dossier only if it survives this scrutiny. It's the scientific method applied to GMP investigation — and the structural defense against anchoring that no checklist can provide.
Evidence, not opinion
Every hypothesis arrives with the document passages that support it, quoted verbatim, and a score decomposed into verifiable dimensions. The system autonomously detects out-of-specification values, contradictions between sources and missing information — it also tells you what it does NOT know, and which documents it would take to find out.
A dossier ready for review
The output is a complete investigation dossier: ranked hypotheses with their evidence, excluded hypotheses with the reason why, Ishikawa diagram, 5-Whys chain, event timeline, correlated historical precedents and relevant regulatory references (ICH Q10, 21 CFR 211.192). Editable drafts the investigator reviews, corrects and completes — not a verdict, a head start.
The final say stays human
QualityMind is decision support, by design: it never writes into your quality systems and approves nothing. Every unresolved tension between pieces of evidence is placed in front of the reviewer, who must examine it before validating. The system makes human judgment better informed — never redundant.
Compliance by design
Everything runs on-premise, in an isolated environment: no data ever leaves the site, no cloud services. 'Locked' AI model (no learning in production), immutable hash-chained audit trail recording every decision of every agent under ALCOA+ principles, consistent with Annex 11 and 21 CFR Part 11. Built in the field, within a major pharmaceutical site in Lazio, Italy.
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