FDASmart Inc., FDA Inspection Training Courses, FDA Consultant, FDA Compliance, FDA Audit, FDA Consulting

Overview

Commercial Software Products - Create 21 CFR Part 11 Compliance Documentation
Description	Advantages of Hiring FDASmart	Class We Developed So Others Can Learn From FDASmart Experience ⁽¹⁾
Companies developing and selling software products to FDA-regulated companies may be unfamiliar with FDA expectations and customer’s needs. Our services include writing SOPs and creating documentation of compliance for the software vendor and their potential customers.	Applying our 15 years of experience in software development, if necessary, We can reverse engineer the information and documentation a computer system requires to be 21 CFR Part 11 compliant.	“Auditing Information Systems – Are You and Your Vendors Part 11 Compliant?”
⁽¹⁾ Contact us and the table of contents from any class can be emailed to you

Commercial Software Products - Create 21 CFR Part 11 Compliance Documentation