GxP Auditing
We find the gaps before inspectors do.
Audit-ready means evidence, not hope. Globiox audits regulated operations the way the FDA will — then helps you close the findings.
Mock FDA Inspectionsinspection readiness
Supplier Auditsvendor qualification
Internal Auditsself-inspection
483 & Warning Letter Responseremediation
Gap Assessmentsiso · cfr
Scopes we cover
GCPGLPGMPGDPGCLPCAP/CLIA
Supplier audits
Your supplier's problem is your finding.
Purchasing controls stop at nobody's front door. ISO 13485 holds you to supplier controls proportionate to risk — §7.4 on the map below — and an investigator follows the trail straight into your approved supplier list. We audit your vendors so that on the day, you show the qualification instead of explaining the gap.
Before a supplier goes on your approved list
Qualification
An on-site or remote assessment of their quality system against the standard you are held to — so approval is a record of evidence, not a leap of faith.
On a cadence set by the supplier's risk
Surveillance
Periodic re-audit of critical suppliers, so the scorecard reflects how they operate today — not how they interviewed years ago.
After nonconforming material or a complaint trail
For-cause
A focused audit that follows one failure to its root — what broke, what escaped, and what corrective action will actually hold.
What you walk away with
An audit plan scoped to the supplier's risk, fieldwork on site or remote, a findings report with graded observations, and a corrective-action tracker — the same artifacts we would expect to see from the other side of the table.
Supplier audits at Globiox are led by career auditors: our president has spent over 30 years as a Quality Systems, Supplier, and Site Qualification Auditor. Meet the team →
Two minutes, no email required
How ready are you, really?
Question 1 of 6
When did you last run a mock inspection or internal audit across your full QMS?
The regulation, as a honeycomb
Every cell is something you can be asked about.
Since February 2026, FDA holds US device manufacturers to the QMSR — ISO 13485:2016, incorporated by reference into 21 CFR 820 — plus two supplemental sections the agency still writes itself. This is all of it. Choose any cell to see what an investigator asks there.
Choose a cell to see what an investigator asks there, and what we hand you.
Further reading
More on this →Auditing
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, 2024AuditingThe FDA’s “dos” and “don’ts” for responding to a 483
DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to…
November 13, 2013AuditingFDA 483: Does your business contain critical errors?
In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed…
August 22, 2012Ready to get inspection-ready?
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