What You Need to Know About FDA 21 CFR Part 11 Validation

FDA 21 CFR Part 11 Validation Process

Validating an ERP system helps a company ensure that their processes are consistent and operate in accordance with industry standards. The 21 CFR Part 11 validation process establishes documented evidence that, throughout its lifecycle, the ERP system will consistently function in accordance with its pre-determined specifications and quality attributes. For pharmaceutical and medical device companies, …