Computer Systems Validation

A White Paper on How to Make your Computer Systems Validation Process Practical Instead of a Compliance Burden

The white paper "A Pragmatic Approach to Computer Systems Validation" explains the function and benefits of applying a risk-based approach to computer systems validation. The paper defines risk-based computer systems validation as not only a regulatory requirement, but also a practice that makes good business sense.

This white paper discusses the concept of ERP computer software validation as presented in FDA guidance documents and 21 CFR Part 11.

MasterControl Validation Excellence (Vx)