First-Rate Procedures Key To Good Internal Quality Audits, FDA Advises

摘要

Conducting robust internal quality audits is an important way for device manufacturers to ensure they fully comply with FDA regulations, agency officials say, but good auditing can't happen without appropriate procedures. "I see internal audits as an incredible, valuable tool that firms should be using. This is the place where they can help themselves," FDA quality system expert Jan Welch said. "Internal audits are a great way to let a firm know if it's compliant."