Title 21 CFR Part 11
What does Title 21 CFR Part 11 mean in manufacturing?

Title 21 CFR Part 11 establishes regulations governing electronic records/electronic signatures ensuring integrity/security compliance within FDA-regulated environments.

Why Title 21 CFR Part 11 is important to your business

Title 21 CFR Part 11 as it applies to manufacturing inspections

01

How to get ISO Certified

Understand requirements, assess gaps, plan improvements, train staff, document processes, and implement the quality management system.

02

How much does ISO Certification cost?

What costs are involved and how long to goes it take to achieve.

03

Choosing the right ISO certification company

Evaluating the knowledge and experience of certification bodies.