Quality Assurance for Regulated Industries

Quality without
compromise.

Globiox turns regulatory risk into audit-ready confidence for medical device, pharma, and biotech teams.

Request an Audit Quote →What we do
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Audits delivered
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TrackWise® implementations
PECB
Certified training partner
SimplerQMS
Certified partner ↗
FDA QMSR⬡ISO 13485⬡FDA 21 CFR 211⬡cGMP⬡GxP⬡CAPA⬡Data Integrity⬡PECB⬡FDA QMSR⬡ISO 13485⬡FDA 21 CFR 211⬡cGMP⬡GxP⬡CAPA⬡Data Integrity⬡PECB⬡
What we do

Four ways we make quality provable.

Build

QMS Platforms

TrackWise® Digital and SimplerQMS — implementation and optimization, configured to how your team actually works.

Explore →Prove

GxP Auditing

Mock FDA inspections, supplier & internal audits, 483 & Warning Letter response.

Explore →Sustain

Training & Certifications

ISO and quality-systems training & certification via our PECB partnership.

Explore →Navigate

Advisory

Gap assessments, CAPA process design, and regulatory & submission support — for the work that does not fit a standard engagement.

Explore →
Who we serve
Medical
DeviceFDA QMSRPharmacGMPBiotechclinical → commercialDiagnosticsIVDCombination
ProductsPart 4

Every one of them answers to an inspector. See who yours is and what we hand you.

Insights

Field notes from the front line of quality.

All insights →
Auditing

Part 11 Compliance Is About the Environment, Not Just the Software

Written by: Patti Rossman A validated system with full audit trails can still produce records that fail 21 CFR Part 11. The software is only half of…

October 8, 2026Auditing

Step-by-Step Strategies for Effective REMS Audit Preparation

Written by: Patti Rossman Preparing for a REMS (Risk Evaluation and Mitigation Strategies) audit can be a daunting task, but with the right approach, it can be…

June 27, 2024Quality & Validation

Staying Ahead: Navigating Timely Training and Version Control in Pharmaceuticals and Medical Devices

written by: Jenny Azarh In the dynamic world of Pharmaceuticals and Medical Devices, maintaining regulatory compliance and ensuring the highest standards of…

March 13, 2024
The Globiox method

From findings to confidence.

01

Assess

Deep gap analysis against FDA / ISO expectations — the mock inspection that surfaces every risk.

02

Remediate

Practical, prioritized fixes your team can implement — CAPA, docs, systems, training.

03

Sustain

Quality habits that hold up years later — not just through the next audit.

Ready to get inspection-ready?

Request an Audit Quote →
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