Meet QMSROOT, powered by RootAí.

Quality Intelligence
that reasons across
the evidence.

Your QMS holds the records. RootAí helps you understand what they mean together.

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Illustrative walkthrough — not a live workspace
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PLATFORM

One platform, one evidence layer, ten connected capabilities.

Five are shown on this page. The rest already exist in the product and simply aren't featured here yet, or are still in development.

FEATURED ON THIS PAGE
FEATURED ON THIS PAGE

RootAí

Every answer, tied back to the evidence that supports it.

?What challenges does FDA QMSR create for our company?
Verified context

FDA QMSR incorporates ISO 13485:2016 by reference.

Potential impact

Existing procedures and Quality controls may require assessment against the applicable requirements.

Unresolved

Organization-specific applicability remains subject to products, markets, current procedures and available evidence.

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FEATURED ON THIS PAGE

GapIdentAí

See exactly what's satisfied, what's missing, and what's still unresolved.

SOP
SOP-114
CAPA EVIDENCE
CAPA-1017
SUPPLIER
SUP-042
Design history file indexSATISFIED
Effectiveness evidenceGAP
Supplier requalification cadenceUNRESOLVED
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FEATURED ON THIS PAGE

DocAí

Drafts controlled documents, and stops honestly at what it doesn't know.

REQUESTEDSOP — Periodic Review
REQUIRED INPUT
Process owner not yet supplied.
04 Procedure

Review interval, trigger conditions, and revision workflow.

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FEATURED ON THIS PAGE

CAPA Intelligence

Also known as CAPA-RootAí in the product

Finds what repeats across your CAPA population, before it becomes a pattern nobody named.

SYSTEMIC SIGNAL
3 findings recur across Supplier Management — Site B and Site C.
Confidence: PartialRelated: 3Review required
POTENTIAL CONTRIBUTING FACTORS
Incoming inspectionSupplier controls
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THE REST OF THE PLATFORM
NOT SHOWN ON THIS PAGE

MockAí Auditor

A practice audit interview: MockAí asks, RootAí evaluates the evidence, and a human decides the outcome.

NOT SHOWN ON THIS PAGE

Corporate Audit Intelligence

Connects historical findings, recurring themes and CAPAs to flag areas that may attract audit attention.

Also shown as "Audit Intelligence" in one workspace view — the same feature, not a separate one.

NOT SHOWN ON THIS PAGE

Company QMS

Your organization's QMS identity and foundation — sites, standards, the Quality Manual and Policy — in one place.

NOT SHOWN ON THIS PAGE

Evidence Library

Documents and supporting evidence available to RootAí, CAPA-RootAí and MockAí are collected here.

ROOTAÍ · REGULATED QUALITY INTELLIGENCE

Explore a question.
See the evidence basis, and what remains unresolved.

Illustrative example data

What challenges does FDA QMSR create for our company?
Regulatory requirementsCompany QMS contextApplicable proceduresProduct/regulatory filesAvailable evidence
Verified context
FDA QMSR incorporates ISO 13485:2016 by reference.
Potential impact
Existing procedures and Quality controls may require assessment against the applicable QMSR requirements.
Evidence to review
Quality ManualDesign controlsCAPAComplaint handlingSupplier controls
Unresolved
Organization-specific applicability remains subject to products, markets, current procedures and available evidence.

Not just an answer. A reasoned answer with evidence boundaries.

ROOTAÍ

Why RootAí is different.

Verified contextUnresolved

Evidence-bounded answers

Distinguishes supplied facts from assumptions, interpretation and missing information.

ProcessesDocumentsProductsCAPAs

Connected Quality context

Reasons across processes, documents, products, findings, CAPAs and regulatory obligations.

AR-014traces to one record

Visible source basis

An assessment carries the evidence and requirements it was built from.

Workspace

Governed source selection

Uses approved workspace information instead of uncontrolled cross-customer context.

RootAí suggests↓You decide

Human decision authority

Supports professional judgement without presenting AI output as approval or fact.

Dispositioned
Signed off · name + time

Human decision trail

Dispositions and sign-off are recorded against a person, and stay with the record.

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GAPIDENTAÍ

Compare the requirement
with what actually exists.

Illustrative example data

QUALITY MANUAL
QM-01
§4.2 Documented information
Applicable to this scope
Reviewed annually
SOP
SOP-114
Periodic review of controlled procedures
Review interval: annual
Owner: process owner
WORK INSTRUCTION
WI-208
Incoming inspection sampling
Sample size per AQL table
Rejection handling
CAPA EVIDENCE
CAPA-1017
Effectiveness review
Result: pending
Due 2026-11-02
SUPPLIER RECORD
SUP-042
Supplier qualification file
Requalification due
Last audit 14 months ago
GAP ANALYSIS — SUMMARY
Design history file indexSATISFIED
Effectiveness evidence — CAPA-1017DOCUMENTATION GAP
Supplier requalification cadenceAPPLICABILITY UNRESOLVED

Know what is supported. Know what is missing. Keep unresolved points unresolved.

GAPIDENTAÍ

A defensible gap picture.

§4.2§7.5§8.5

Requirement-by-requirement analysis

Evaluates each relevant obligation instead of producing a generic document summary.

Gap↕CAPA-1017

Evidence-linked gaps

Connects every identified gap to the source document, record or missing evidence.

SatisfiedGapUnresolved

Clear assessment boundaries

Separates confirmed gaps, partial evidence and unresolved applicability — never blended into one score.

HighMediumLow

Risk-based prioritisation

Helps teams focus on gaps with the greatest quality, regulatory or audit exposure.

ISO 13485FDA QMSRIATF 16949Customer
Medical device · Automotive · Customer-specific

Cross-standard comparison

Illustrative: the same gap-analysis capability applied to medical-device standards, an automotive standard (IATF 16949) and customer-specific criteria alike — not a separate built-out workflow per industry.

Request evidence
Assign action

Action-ready outputs

Converts findings into structured actions, evidence requests and verification needs.

No evidence found≠Compliant

No false compliance claims

Absence of evidence is never silently treated as evidence of compliance.

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DOCAÍ

Documentation that knows
when it still needs you.

Illustrative example data

workspace / docai / draft
REQUESTEDSOP — Periodic Review of Controlled Procedures
Company QMSApplicable requirementsDocument hierarchyExisting procedures
01Purpose
Defines why this procedure exists and its intended outcome.
02Scope
Applies to all controlled procedures within the quality management system.
03Responsibilities
REQUIRED INPUT
Process owner not yet supplied.
04Procedure
Review interval, trigger conditions, and revision workflow.
05Records
Review log, revision history, approval signatures.
06References
Document Control SOP, applicable regulatory framework.

Create with context. Stop where evidence stops.

DOCAÍ

Documentation with control.

ControlledWorking draft

Controlled and working-document lanes

Distinguishes governed QMS documents from flexible AI-assisted drafts.

SOPWork InstructionForm

Purpose-built QMS structures

Supports manuals, policies, SOPs, work instructions, forms, reports and templates.

+ evidence

Evidence-informed drafting

Uses selected source documents and workspace evidence when provided.

REQUIRED INPUT
Process owner

Required-input safeguards

Identifies missing owners, approvals, requirements and operational details rather than inventing them.

Preview→PDFDOCX

Structured preview before export

Lets users review the document before producing PDF or DOCX output.

Professional document rendering

Supports headings, tables, checkboxes, entry lines and editable form structures.

Draft — not approved

Explicit governance boundaries

A generated draft is never represented as approved or automatically compliant.

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CAPA INTELLIGENCE

See what repeats across the population.

Connect findings, complaints, audits and CAPAs to find systemic signals early.

Illustrative example data

CAPA-1042Open
Incoming inspection sampling plan
Site B · Supplier Management
CAPA-1039In Progress
Supplier corrective action — Site B
Site B · Supplier Management
CAPA-1017Effective
Supplier corrective action — Site C
Site C · Supplier Management
CAPA-0998Under Review
Labeling discrepancy
Site A · Labeling
CAPA-0867Closed
Design input update
Site C · Design Controls
SYSTEMIC SIGNAL
3 findings recur across Supplier Management — Site B and Site C.
ConfidencePartial
Related3
Review req.Yes
DETERMINISTIC FACT
3 findings recur across Supplier Management — Site B and Site C.
ROOTAÍ INTERPRETATION
May indicate a systemic gap in incoming-inspection sign-off.
POTENTIAL CONTRIBUTING FACTORS
Incoming inspectionSupplier controlsSampling planLot releaseDocumentationTraining
NEXT STEPS — HUMAN DECISION
Review affected procedures
Validate sampling approach across sites
Assess training and competence records
Confirm effectiveness of existing CAPAs

RootAí surfaces patterns and suggests areas to review. It does not create, link, accept or close CAPAs.

See the pattern. Investigate the cause. Keep the decision human.

CAPA INTELLIGENCE

From investigation to systemic intelligence.

ProblemRoot cause?

Investigation before conclusion

Prevents jumping from a problem statement straight to a convenient root cause.

H1
H2H3

Hypothesis-driven analysis

Develops and tests multiple causal explanations against the available evidence.

SupportsContradictsRelates

Evidence relationships

Shows whether evidence supports, contradicts, or merely relates to a hypothesis — never all treated the same.

AcceptReturn

Human-controlled causal decisions

Accountable reviewers accept or return causal findings, with the rationale on record.

Contain↓Correct↓CAPA

Action-to-cause alignment

Distinguishes containment, correction, corrective action and preventive action — never one blurred step.

VERIFICATION DUE2026-11-02

Effectiveness planning

Defines how the organization will verify that an action actually addressed the accepted cause.

Portfolio intelligence

Identifies repeat patterns, overdue work and systemic signals across the whole CAPA population.

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ENTERPRISE ARCHITECTURE

Sits alongside your existing systems. Reads from them, never replaces them.

EXISTING SYSTEMS
Where the evidence already lives
  • eQMS / Quality Management
  • Document Control / DMS
  • ERP / MES
  • LIMS / CRM
  • Supplier & Complaint Systems
  • SharePoint / Repositories
  • Regulatory Systems
QMSROOT
Quality Intelligence Layer
  • Connects evidence across systems
  • Applies deterministic checks and RootAí assessment
  • Preserves source traceability
  • Uses governed organizational context
  • Keeps decision authority with Quality
CONNECT→
CLASSIFY→
REASON→
SURFACE
GOVERNANCE & CONTEXT
Approved evidence · Workspace isolation · Traceability · Access control · Human authority
OUTCOME
Quality Intelligence
  • Audit-ready, traceable briefings
  • Systemic signals surfaced early
  • Gap assessments
  • Regulatory impact visibility
  • Quality actions requiring attention

Your systems remain authoritative. QMSROOT adds the intelligence layer.

Illustrative architecture — not every connector or integration is available today.

INSIGHTS

Regulatory intelligence, in practice.

What's actually changing in regulation, audit practice, and where AI genuinely helps a quality system.

REGULATORY INTELLIGENCE

FDA QMSR Is Live: What Changed for Quality Teams — and What Became More Visible

FDA's QMSR changed more than the structure of 21 CFR Part 820. It changed what investigators can inspect across management review, internal audits and supplier audits.

QMSROOT Intelligence14 September 2026about 4 min read
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RootAí advises. Quality decides. Evidence shows why.

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