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/ Qualitus · QMS
Qualitus
The quality system your PV team will actually use.
Qualitus is a purpose-built QMS for pharmacovigilance and life sciences organisations: audits, CAPA, training, the LPV network, messaging, time tracking and analytics — with per-tenant isolated data and a design that matches the Salvus platform your teams already know.
Key capabilities
Audit Management
CAPA Tracking
Training Management
LPV Network
Messaging & Collaboration
Time Tracking
Audit + CAPA + Training
Core QMS modules
LPV network
Multi-jurisdictional
Per-tenant isolation
Data & access
Real-time
Quality analytics
What it does
All the capability, none of the complexity.
Qualitus is a purpose-built QMS for pharmacovigilance and life sciences organisations: audits, CAPA, training, the LPV network, messaging, time tracking and analytics — with per-tenant isolated data and a design that matches the Salvus platform your teams already know.
01
Audit Management
Plan, schedule and execute internal and external PV audits. Configurable audit programme, checklist templates per audit type. Findings tracked to closure with evidence.
02
CAPA Tracking
Corrective and preventive actions with root-cause categorisation, owner assignment, due dates, effectiveness verification. CAPA ageing dashboard flags overdue items early.
03
Training Management
Training curriculum builder, assignment by role and module. Completion tracking with evidence upload, expiry management and automated reminder ladders.
04
LPV Network
Local Person for Pharmacovigilance network management: contact directory, jurisdiction assignments, task delegation and competency records.
05
Messaging & Collaboration
Secure internal messaging with audit trail, @mentions and task creation directly from conversations — PV team communication in the quality record.
06
Time Tracking
Effort capture per module, product and activity type — supporting resource planning, contract billing and regulatory obligation evidence.
07
Reports & Analytics
Standard report library covering CAPA metrics, audit programme status, training compliance, LPV coverage and quality KPIs. Ad hoc builder with scheduled distribution.
08
Admin Panel
User management, role assignment, product catalogue and configuration with audit trail. Multi-tenant architecture with strict data isolation.
How it works
From day one to every day after.
A typical journey through Qualitus — from onboarding to steady-state operations.
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Observation captured
Audit findings, process deviations and quality events enter Qualitus directly or via integrations from other Salvus modules.
CAPA assigned
Root cause documented; corrective and preventive actions assigned with owners, deadlines and effectiveness verification criteria.
Training actioned
Where training gaps are identified as root cause, training assignments created and linked to the CAPA record.
Closure & reporting
Actions verified for effectiveness and closed with evidence. Aggregate quality metrics update the dashboard and feed the PSMF quality system section.
See It in Action
Watch Qualitus in action.
A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.
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How to add your demo video
1. Upload the Qualitus demo to YouTube.
2. Copy the video ID from the URL — the part after watch?v=
3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"
4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.
5. Save & deploy — the play button handles the rest automatically.
Integrations
Connects where you need it to.
Qualitus is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.
ICSR
Quality findings from case review
Signum
Process quality metrics from signal management
RMP
Quality oversight of risk management activities
Reg Intelligence
Regulatory intelligence action tracking
Compliant with
ISO 9001:2015
GVP Module I
EU 726/2004 Art. 23
ICH Q10
21 CFR Part 11
GAMP 5
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