Real-Case PV Operations · Not Simulation

The governed workspace
where real safety cases
get done.

MedClariva PV Tools is a clinician-led pharmacovigilance operations workspace — built for live case handling, reviewer control, and quality governance, not for training on fictitious data.

Queue-based intake, reviewer and QC checkpoints, first-class deviation and CAPA registers, and a time-stamped audit trail on every action — so your team can show exactly what happened, who did it, and how it was corrected.

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Audit-trailed by default
Role-based review & QC
CAPA-linked quality
Export-ready evidence
Clinician-led design

One workspace, from intake to evidence

Case work, quality governance, and oversight reporting in a single role-aware environment — so case status and quality status never blur together.

01 / Operations
Case Operations
Intake · processing · review · QC

Queue-first case handling with clear ownership and clocks. Processors execute, reviewers decide, and nothing progresses silently.

  • Intake queue with duplicate, completeness & seriousness triage
  • Central case table — source, seriousness, stage, QC & review state
  • Reviewer return-for-correction and approval flows
  • Case detail with intake facts, medical review & follow-up status
02 / Quality
Quality & CAPA
Deviations · CAPA · effectiveness

Quality exceptions become managed objects — not comments lost inside a case. Findings link to deviations; deviations link to CAPA.

  • Deviation register with severity, ownership & status
  • CAPA register with corrective and preventive components
  • Owner, due date and effectiveness check on every CAPA
  • QC findings categorised and linkable to triggers
03 / Oversight
Oversight & Reporting
Audit trail · reports · exports

Governance visibility for QPPV and oversight leads — what's overdue, what recurred, and what can be handed to an inspector.

  • Global and object-level audit trail of actor-action history
  • Throughput, QC trend, CAPA aging & reviewer turnaround
  • Deviation and CAPA register exports
  • Inspection-evidence packaging as a first-class output
The Operating Path

A defined route from case to correction

Every case follows the same governed path — and every step writes an auditable event. Quality progression runs alongside case progression, so a closed case never hides an open finding.

Step 01
Intake
Triage, duplicate & completeness checks; seriousness flagged.
Step 02
Process
Case build, medical review, follow-up tracking.
Step 03
Review
Reviewer approves, holds, or returns for correction.
Step 04
QC
Checkpoints; findings categorised & linked to triggers.
Step 05
Submit
Closure / submission readiness with clock visibility.
Step 06
Improve
Deviation → CAPA → effectiveness check closes the loop.
Who It's For

Built for the people who own the case file

A focused operational workspace for small-to-mid complexity PV teams that need structure, traceability and review control — without taking on a full enterprise-database replacement on day one.

Safety Operations Lead
Structure & assignment control

Small pharma, biotech, digital health or emerging PV teams that need workflow oversight, assignment management and quality review in one place.

Start with Overview & Cases
Case Processor
Queue-based execution

Clear queues, documented handoffs and review clarity — so incomplete cases never progress without an explicit decision.

Start with the Intake Queue
Reviewer / QC
Checkpoints & returns

Case-level checkpoints, returns, comments and finding visibility — with repeated finding categories surfaced for governance insight.

Start with Review & QC
QPPV / Oversight
Quality-system visibility

Audit traceability, CAPA monitoring and exportable evidence — the view a QPPV needs to answer an inspector without a fire drill.

Start with Audit Trail & Reports
Where It Sits

Operations, not training

MedClariva has separate products for learning and for live work. PV Tools is the operational one — and it is deliberately kept distinct so real case work and practice work never share an environment.

Learn
PV Academy
Fictitious data

Practical workflow learning for individuals and cohorts. Training on simulated cases — never real safety data.

Practise
PV Sandbox
Fictitious data

Organisation-licensed team simulation and readiness drills. A workspace for rehearsal — still on simulated data.

Operate
PV Tools
Real-case operational use

The governed workspace for live case handling, quality governance and oversight. Audit-trailed, role-based, CAPA-linked.

Questions

Before you pilot

Academy and Sandbox are learning environments that run on fictitious data — for training individuals and rehearsing teams. PV Tools is the operational product: it is designed for real-case handling, with governance expectations that simulation products do not carry. They share a brand and a visual language, not a database.
Intake and case processing, reviewer and QC workflows, a deviation register, a CAPA register with effectiveness checks, a global and object-level audit trail, and governance reporting with exports. CAPA and deviations are first-class modules in their own right — not buried inside QC detail.
No — and it does not pretend to be. PV Tools is a focused operational workspace for small-to-mid complexity teams that need structure, traceability and review control first. Broad submission infrastructure and deep enterprise customisation are deliberately treated as later-stage roadmap items, not day-one claims.
Every meaningful action generates a time-stamped, attributable audit event. Audit is available both globally and on each case, deviation and CAPA. Review and approval actions are role-gated, and export access is governed by role and purpose. Compliance posture is framed as product direction, scoped to what the platform enforces today.
Yes — that is the intended rollout. PV Tools is built for design-partner pilots: start with core case operations, then expand into quality, CAPA and oversight modules as your team adopts queue-based working. Pilot conversations are scoped honestly, without overclaiming enterprise replacement.
PV Tools is built by MedClariva — the independent practice of Dr Varun Kumar Gone, MD, MRCP (UK), a practising physician building the safety systems he advises on. The design reflects a clinician's view of how case work, review discipline and quality governance should actually fit together.
Get Started

See PV Tools on your workflow

Book a walkthrough, request a design-partner pilot, or talk through how your intake-to-CAPA flow should be structured. Clear scope, senior physician perspective, no enterprise hand-waving.

Book a Demo Request a Pilot Discuss Your Workflow
tools.medclariva.com · Governed PV operations · Real-case data posture