In-house Systems - Create 21 CFR Part 11 Compliance Documentation

Description

Advantages of Hiring FDASmart

Class We Developed So Others Can Learn From FDASmart Experience (1)

When companies develop in-house computer systems with insufficient information to prove FDA compliance, there’s a need to produce documentation (including SOPs) to pass any potential FDA audit.

Applying our 15 years of experience in software development, 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