Navigating pharmaceutical regulations, like the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11, involves complexities like system validation, audit trails, and maintaining accurate records. Cognex machine vision and barcode scanners make it easy.
What You’ll Learn
- Requirements: detailed breakdowns of validation, audit trail, and operational and authority checks required by the FDA and other equivalent standards.
- Use cases: learn how machine vision systems can ensure 21 CFR Part 11 compliance while mitigating costs by pinpointing quality control issues, validating processes, and creating unalterable audit trails.
- Case study: real-world example of how Cognex machine vision verified pharmaceutical labels, read optical characters, and generated audit trails, helping a pharmaceutical customer meet 21 CFR Part 11 standards while minimizing costs.
- FDA guidance on Advanced Manufacturing Technologies (AMT): the benefits of the FDA’s AMT program and how Cognex uses AI to improve inspection capacity and capabilities.
Download the 21 CFR Part 11 whitepaper to learn how Cognex solutions can streamline compliance, improve product quality, and mitigate costs.
