RootAí · Quality + Regulatory
Meet RootAí,
your new Quality & Regulatory colleague.
Quality & Regulatory support, on demand.
Bring the difficult question. RootAí works with current regulatory sources, your evidence and your company context to help establish what applies, what is missing and what to do next.
- Regulatory sources
- Your company context
- Your evidence
Can the PRRC block this release?
Does QMSR apply to this product?
What evidence is missing from this CAPA?
What do we need to do after this supplier traceability failure?
How should we document this regulatory decision?
Bring it something genuinely difficult.
RootAí can work across requirements, standards, internal evidence and organisational context instead of treating each question in isolation.
A good colleague knows when to ask back.
RootAí does not manufacture certainty simply to produce an answer.
What is established
Held against the applicable requirements and the evidence in front of it.
What still needs evidence
Named as open, rather than filled in with an assumption.
What needs your decision
Left with you. RootAí advises; the Quality decision stays yours.
From requirement to action.
RootAí does not stop at quoting a regulation. It helps translate the applicable requirement into the Quality work that follows.
Containment
Stop further risk.
Supplier corrective action
Document corrective action.
Traceability assessment
Understand the impact.
Product impact / risk
Assess and document.
Evidence expectations
What must be reviewed.
Escalation / next actions
Define the path forward.
Not every source carries the same authority.
RootAí keeps the source basis visible, so requirements, guidance and standards do not quietly become the same thing.
- REGULATORY_REQUIREMENT
- AUTHORITATIVE_GUIDANCE
- STANDARD_REQUIREMENT
One intelligence across the platform.
RootAí brings evidence-grounded intelligence to supported Quality workflows. The direction is intelligence across the connected Quality record itself — relationships, patterns and systemic Quality signals — always advisory, always put to a qualified person.
Regulatory questions
Answers built on current sources, each labelled for its authority.
Gap analysis
Your evidence against the requirements, gap by gap.
Management Review
Input readiness assessed from the evidence actually supplied.
Your Quality registers
CAPA and audit records brought into the conversation.
Your next difficult Quality & Regulatory question doesn’t have to wait.
Meet RootAí.