FDA readiness checklist: evaluate your QMS in 20 minutes

Why download?

This FDA readiness scorecard helps you assess whether your QMS is prepared to respond to Form 483 observations in line with the FDA’s March 2026 draft guidance. In less than 20 minutes, you will uncover gaps across inspection readiness, investigations, CAPAs, data integrity, and quality culture.

This FDA readiness scorecard includes:

• A 20-question self-assessment aligned with the FDA’s March 2026 draft guidance.
• A maturity scoring model to benchmark your FDA inspection readiness.
• Five assessment areas covering inspections, investigations, CAPAs, data integrity, and quality culture.
• Score bands with tailored next-step priorities based on your results.
• Practical guidance to strengthen Form 483 response readiness.
• Access to the Scilife FDA Action Kit with templates, checklists, and response resources.