QMSROOT Solutions
Engineered for Regulatory Precision.
eQMS workflows and Quality Intelligence for the work that matters most.
Connect fragmented quality evidence. Understand what it means together. Surface what deserves attention. Give Quality and Regulatory teams the context to make defensible decisions.
Connect
Bring relevant quality evidence into context.
Understand
RootAí examines relationships across records, requirements and company context.
Surface
Bring patterns, gaps, reporting exposure and evidence that may require attention forward.
Decide
Quality accepts, rejects, investigates or escalates while retaining the human decision trail.
Run it natively.Or alongside what you run.
Native eQMS workflows and AI Quality Intelligence.
Hold supported Quality records in QMSROOT, or analyse evidence imported from the systems you already use. Whichever holds the record stays authoritative.
QMSROOT adds the Quality Intelligence around that evidence — assessment, context, relationships, regulatory relevance and controlled human decisions.
For Enterprise
Avoid unnecessary system replacement and large-scale record migration.
01 · Audit Readiness & Execution
Experience the audit before the audit.
Static checklists do not tell you how an audit conversation will actually hold up.
- 01
Question
From the audit agenda, traced to the requirement.
- 02
Answer
In the auditee’s own words.
- 03
Challenge
A vague answer is not accepted.
- 04
Evidence
The specific record, form or procedure behind it.
MockAí follows the audit agenda, challenges vague responses and asks for the specific record, form, procedure or evidence item behind the answer.
MockAí challenges. The auditor decides.
Move from static audit preparation to an evidence-driven rehearsal before the real audit.
Explore MockAí Auditor02 · CAPA & Recurrence
See recurrence before another CAPA is treated as an isolated event.
CAPA records are often reviewed one at a time, even when the meaningful pattern exists across the population.
CAPA Intelligence helps teams examine comparable CAPA populations, surface recurring themes and bring relevant records forward for investigation.
RootAí can support the analysis, but it does not decide the root cause.
The question is not only “what happened here?”
It is also “have we seen this before?”
Make recurrence harder to overlook while keeping the investigation and final decision with Quality.
Explore CAPA Intelligence- CAPA population
- Related / comparable records
- Evidence-grounded observations
- Individual record review
- Human disposition
03 · PMS & Vigilance Exposure
Know which complaint needs attention before the reporting window becomes the problem.
Complaint teams must evaluate evidence while working against regulatory reporting timelines.
Complaint
Assessment
Unresolved information
Reporting pathway · awareness confirmation
Deterministic regulatory clock
Radar queue
PMS Radar combines complaint assessment support with deterministic FDA MDR and EU MDR reporting timelines so unresolved reporting exposure is visible during review. The awareness date and pathway remain human-confirmed.
Faster complaint review and earlier visibility of FDA/EU reporting exposure.
Explore PMS RadarThe clock should make exposure visible — not manufacture the reporting decision.
04 · Regulatory Change
The alert is the easy part.
The impact is the work.
A regulatory update only becomes useful when it can be examined against the organisation it may affect.
- Does it apply to us?
- What may be affected?
- What needs review?
External change
Regulation, guidance or standard update.
Your regulatory context
- Jurisdiction
- Authority
- Instrument type
- Status
- Instruments you follow
Review context
Relevant areas surfaced for human assessment.
Human decision
RootAí brings external change into the context of the organisation before the impact decision is made — current sources, labelled for their authority, read against your products, markets and procedures.
Turn regulatory change into a structured applicability and impact-review process.
Explore RootAíFrom “what changed?” to “what does this change mean for us?”
Quality Intelligence for the decisions that don’t fit neatly inside one workflow
See what an isolated record cannot tell you.
- CAPA
- Complaint
- Audit evidence
- Controlled document
- Requirement
RootAí
Relationships · gaps · context requiring review
Human decision
RootAí can bring multiple pieces of Quality and Regulatory evidence into one governed assessment, helping teams examine relationships, gaps and context that are difficult to see when records are reviewed separately — cross-record reasoning within the evidence available to the consultation.
Move difficult Quality & Regulatory questions from fragmented evidence toward a structured, source-backed human assessment.
Meet RootAíBring the question that does not fit neatly inside one workflow.
The outcome is not another search result. It is a clearer view of the evidence behind the decision.
QMSROOT applications
Put the intelligence to work.
The same Quality Intelligence foundation is applied across different Quality and Regulatory workflows — from difficult day-to-day questions to CAPA, PMS, audits, regulatory change and controlled documentation.
RootAí
Quality & Regulatory decision support
Bring difficult Quality and Regulatory questions into one evidence-grounded consultation.
Meet RootAí →MockAí Auditor
Evidence-challenging mock audits
Run the audit conversation, challenge vague answers and ask for the evidence behind them.
Explore MockAí Auditor →One intelligence foundation. Different Quality workflows.
CAPA Intelligence
Investigation and recurrence intelligence
Examine CAPA populations, surface comparable records and support evidence-grounded human review.
Explore →PMS Radar
Complaint assessment and reporting exposure
Support complaint review while keeping deterministic FDA MDR and EU MDR reporting exposure visible.
Explore →GapIdentAí
Requirement-to-evidence gaps
Assess whether available evidence supports the requirement and leave unresolved gaps visible.
Explore →DocAí
Controlled-document intelligence
Support source-grounded drafting and review while keeping missing evidence and assumptions visible.
Explore →Two ways into QMSROOT
Keep the systems that work.
Add the intelligence they’re missing.
Enterprise
Build above the record layer.
Keep the QMS, ERP, PLM and document environments your organisation already depends on.
QMSROOT analyses evidence imported from those systems today, and is designed to add controlled integrations as they become available — without making system replacement the starting point.
Architecture direction
Existing systems of record
eQMS · ERP · PLM · DMS
- Controlled evidence access
- QMSROOT Quality Intelligence
Avoid unnecessary system replacement and large-scale record migration.
Private / growing organisations
Native when you need it.
Optional when you don’t.
When there is no existing governed evidence environment to build on, Company QMS can provide the native workspace underneath QMSROOT Quality Intelligence.
- QMSROOT Company QMS
- QMSROOT Quality Intelligence
Same intelligence architecture.
Different evidence source.
Quality Intelligence starts with the evidence you already have.
Bring the Quality and Regulatory work that matters most. Keep human authority where it belongs.