Regardless of how FDA ultimately regulates tobacco, whether as a drug or a nutraceutical or anything in between, FDA Compliance also requires compliance with 21 CFR Part 11 - Compliance for Electronic Records and Signatures (similar to Alcohol and Tobacco Title 27 Part 73 Electronic Signatures), if such systems are used in production or the clinic. Every computerized system that is regulated by the Good X Practices (GxP) - manufacturing, laboratory, clinical, etc. - needs to be validated.
Computer System Validation’s principal David Nettleton provides a highly interactive course that explains what computerized system validation and Part 11 means for companies involved with tobacco products, so they can ensure compliance and avoid drug-like Form 483 citations and warning letters.
The three primary areas of Part 11 drug compliance are explored: SOPs, software product features, and validation documentation. The three-hour course details the required characteristics of software for security, data transfer, audit trails, electronic signatures, validation, training, and supporting SOP infrastructure. David Nettleton, an FDA expert with considerable success at ensuring quality computer systems for FDA compliance, says the course will detail the following:
- Understand what Part 11 means, not just what it says in the regulation.
- Electronic signatures and biometric signatures
- Learn the product features to look for when purchasing COTS software
- Learn what software developers must do to create regulated applications
- Understand the SOPs required to support computer systems
- Reduce validation resources by using fill-in-the-blank validation documents: requirements, specifications, hazard analysis, testing, release.