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Qualitus

Unified Quality Management for Regulated Teams — Audit, CAPA & Training in one place

Reduce compliance risk, close findings faster and scale training programs with a single configurable platform built for life-sciences, medical devices and pharma organizations.

35%

Time to close CAPA

40%

Audit prep time

98%

Training completion

Integrations & Automation

Connect with your existing systems — HR directories, LMS, eTMF, LDAP / SSO and data warehouses. Built-in rules automate assignments, escalations and notifications so your team spends time fixing problems, not chasing them.

SALVUS COMPLAINT TO 10+ PHARMACEUTICAL REGULATORY AGENCIES
US FDA
EMEA
Swissmedic
Health Canada

Platform features — built around three core modules

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Audit Management

Plan, schedule and manage internal and external audits with risk-based calendars, auditor assignments, findings tracking and integrated evidence collection.

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CAPA Management

Identify root cause, assign actions, track effectiveness checks and automatically escalate overdue items. Full audit trail for inspectors.

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Training Management

Create learning paths, assign role-based curricula, monitor completion and auto-generate training evidences for inspections and submissions.

Why choose Tesserblu QMS?

Configurable workflows

It adapt processes without code

Compliance-first

It designed for ISO, GxP, MDR/IVDR and FDA expectations

Audit-ready evidence

It timestamped attachments, digital signatures & exportable reports

Secure & Scalable

It is role-based access, encryption at rest and in transit

Stack of Envelopes
Ready to see it in action?

Book a personalized demo, request a pilot, or ask for validation documents. We'll show how Tesserblu fits into your current systems and compliance program.

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  • 30-minute walkthrough with a product specialist

  • Proof-of-concept available for enterprise pilots

  • Validation & regulatory support available

"Tesserblu cut our audit prep time in half and made CAPA follow-up transparent across sites."

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QA Lead, Medical Device Company
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"The training workflows and evidence exports were inspection-ready on day one."

Head of Compliance, Pharma

Testimonials

What customers say

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