Meeting FDA and 21 CFR Part 11 Compliance: How Automation Simplifies a Complex Challenge
Industry Insights Meeting FDA regulations and 21 CFR Part 11 requirements is a major challenge for regulated industries such as pharma, biotech, food, and medical manufacturing. These rules demand strict control over electronic records, user access, data integrity, and audit trails. Many plants still rely on manual logs, spreadsheets, and disconnected systems. This creates gaps […]
