FDA Compliance & Calibration Survival Guide

In FDA-regulated environments, calibration issues rarely show up as small problems. A
missing record, incomplete certificate, or poorly handled out-of-tolerance event can
quickly escalate into inspection findings, production delays, or deeper quality
investigations. Calibration isn’t just maintenance; it’s a core part of your compliance
strategy.

Our new eBook, “FDA Compliance & Calibration Survival Guide,” walks through
how to build a calibration program that supports inspection readiness, defensible
documentation, and long-term measurement control.

What You’ll Learn:

• How FDA inspectors evaluate calibration programs
• What makes a calibration certificate complete and defensible
• Why “pass/fail only” results create compliance risk
• How to properly manage out-of-tolerance (OOT) events
• How to assess your current program before an inspection does

Bonus Tools Included:

• Calibration Certificate Checklist to help you review and approve certificates
  with confidence
• Calibration Program Self-Assessment to benchmark your current processes
  and identify gaps

If your team is responsible for quality, compliance, or calibration oversight, this guide will
help you identify gaps early and strengthen your program with confidence.