Who it's for, why it exists, what it does.
A short introduction to QMSROOT.
QMSROOT · Interactive consultation
Ask something hard.Watch what the answer stands on.
RootAí asks for what it needs before it answers, shows which sources it relied on and what kind of authority each one carries, and says plainly what it could not establish.
RootAí · Quality & Regulatory consultation
Your question
Can the PRRC block release of finished devices containing a component batch with a known traceability failure?
RootAí needs context first
The answer depends on your organisation. Rather than assume, RootAí names what it is missing — the product calls these required inputs, and they are kept separate from the actions it recommends.
Supply at least two. RootAí will answer with less — it will just be clearer about what it could not establish.
Fixed illustrative consultation. No visitor documents or customer QMS records are processed. RootAí can make mistakes — verify important information before relying on it.
QMSROOT · Interactive audit
Auditors have their own language.MockAí teaches it while it audits you.
Answer the way you normally would. When it isn’t enough, MockAí shows you what the question was really asking for — then lets you answer again.
Audit agenda · question 4 of 12 · traces to ISO 13485:2016
MockAí asks
Show me the evidence that the CAPA effectiveness check was completed.
Your answer — how would you reply?
Neither is a trick. Both are what people genuinely say in audits.
MockAí challenges. The auditor decides.
This interactive example uses fixed audit scenarios to demonstrate MockAí behaviour. It does not process visitor documents or customer records.
QMSROOT · CAPA register analysis
Your CAPAs stay in your system.QMSROOT tells you which ones need a second look.
Read-only. No migration, no second register. QMSROOT reads what you already have and surfaces the repeat cases, the late actions and the closures that were never evidenced — quoting the record’s own dates, status and text so you can check it yourself.
Your CAPA sources — nothing moves
Your eQMS
TrackWise · Veeva · MasterControl
Read onlySharePoint
Document repositories
Read onlyCAPA archive
Historical packages
Read onlyBulk import
CSV · XLSX
Read onlyYour register stays where it is. QMSROOT reads and analyses — it does not alter source records, and there is no migration. Source systems remain authoritative.
Scope
Period · last 12 monthsSite · allProcess · allSource · allAssess the population you choose, not everything at once.What it surfaced
Population analysed: 12 · 8 need attention · 4 do not
1
Repeated cases
A CAPA was declared effective and the issue recurred. The effectiveness conclusion is contradicted by the record itself.
3
Closure without evidence
Two closed with no effectiveness check planned or recorded; one closed with an ineffective result.
2
Late and drifting
One corrective action past its due date with no completion recorded; one effectiveness check overdue.
Action overdue
1
Needs attention
Action due within 7 days
0
Needs attention
Effectiveness check overdue
1
Needs attention
Effectiveness check due within 7 days
1
Needs attention
Closed without effectiveness check
2
Needs attention
Closed with ineffective result
1
Needs attention
Closed with open action
0
Needs attention
Chronology inconsistent
1
Needs attention
Record incomplete
1
Needs attention
Repeat signal
1
Population signal
Effectiveness contradicted by recurrence
1
Needs attention
Two of the twelve assessed records shown. The rest are not reproduced here.
CAPA Intelligence reads, compares, surfaces and suggests. You verify, decide and act. It never creates, links, accepts, or closes anything.
Fixed illustrative assessment run. No file is imported and no customer CAPA record is processed. Source systems remain authoritative.
QMSROOT · PMS Radar
Which complaint is closest to a reporting deadline?And can you prove you looked?
Export your complaints, map the columns once, and PMS Radar assesses every record — surfacing the timing exposure, the investigation gaps and the missing evidence, each quoted from the complaint itself.
PMS_Radar_Controlled_Test_Set_15.xlsx · 15/15 records assessed
Population analysed: 15 · Needs attention: 8
Regulatory & vigilance
Derived from confirmed chronology and the stated reporting pathway only
- Potentially overdue reports2
- Reports due within 7 days1
- Reportability assessment concerns2
- Regulatory timeline not assessable1
Operational workload
Source-system task dates — never a regulatory deadline
- Source tasks overdue4
- Source tasks due within 7 days3
- Completed after planned finish1
- Unassigned tasks1
A task due date is not a reporting deadline. PMS Radar keeps them apart — because the warning letter comes from the one on the left.
Evaluation queue — prioritised by why it needs attention
Complaint data in, grounded assessment out — prioritised human action with a traceable decision trail.
Fixed illustrative run. No complaint export is imported and no customer record is processed. Reporting timelines shown are derived from confirmed chronology and a stated reporting pathway; where either is missing, PMS Radar says the timeline is not assessable rather than guessing.
Seen enough? Let’s talk about your environment.
Discuss your Quality and Regulatory scope, evidence environment and deployment path with QMSROOT.
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