21 CFR Part 11 Assessment & Validation Case Study - IndiumSoftware

21 CFR Part 11 Assessment & Validation Case Study

21 CFR Part 11 Assessment Validation Case Study

The client was a firm that provided innovative biopharmaceutical solutions from discovery to development and commercialization. The client had a Laboratory Information Management System (LIMS) with no proper deployment documents. They needed a QA partner to ensure that the application was compliant with CFR Part 11 regulations.