Built for real Quality & Regulatory work.
ROOTAi is designed to support complex quality and regulatory decisions by connecting evidence, challenging assumptions and making the reasoning traceable.
Not another isolated AI tool.
A Quality reasoning layer across the QMS.
1. Investigations & Root Cause Analysis
Move beyond the first plausible explanation.
ROOTAi helps structure evidence, develop and challenge hypotheses, identify missing information and test whether a proposed root cause is actually supported by the facts.
Supports:
Investigations · 5 Whys · Fishbone · Hypothesis testing · Evidence sufficiency · Root cause defensibility
2. CAPA & Effectiveness
From root cause to corrective action — with the logic intact.
Connect root causes to corrective actions, identify weak action logic and assess whether effectiveness evidence demonstrates that the problem was actually controlled.
Supports:
CAPA planning · Action logic · Implementation evidence · Effectiveness assessment · Recurrence review
3. QMS & Document Review
Read the document. Understand the control. Find the gap.
ROOTAi evaluates QMS documentation against applicable requirements while distinguishing documentation issues from substantive process deficiencies.
Supports:
SOP review · WI review · Policy assessment · Missing controls · Internal consistency · Evidence gaps
4. Compliance & Gap Assessment
A gap is only useful when you understand its significance.
ROOTAi helps compare requirements with actual controls, classify gaps and focus attention where compliance exposure is meaningful.
Supports:
Gap analysis · Requirement mapping · Applicability · Severity · Priority · Remediation planning
5. Audit Readiness
Find the weak reasoning before the auditor does.
Review quality evidence, identify inconsistencies and test whether decisions can be reconstructed and defended.
Supports:
Audit preparation · Evidence review · Finding assessment · Traceability · Readiness checks
6. Regulatory Reasoning
Understand what the requirement actually changes.
ROOTAi supports applicability and impact assessment across regulatory requirements, QMS processes, documentation and implementation evidence.
Supports:
Regulatory applicability · Change impact · QMS impact · Documentation impact · Implementation evidence
The intelligence is in the connections.
Complaints. CAPAs. Audits. Risk records. QMS documentation.
Individually, they are records.
Together, they may reveal the system-level signal.
CONNECT · CHALLENGE · DEFEND
CONNECT the evidence.
CHALLENGE the reasoning.
DEFEND the decision.
ROOTAi — Coming Soon
Be among the first Quality & Regulatory professionals to put ROOTAi to work.
Quality Intelligence. From Evidence to Root Cause.