21 CFR Part 11
FDA regulation for electronic records and signatures in pharmaceutical.
Key Takeaways
- FDA regulation for electronic records and signatures in pharmaceutical.
- Advanced-level topic in Project Development & Documentation
Detailed Definition
FDA regulation for electronic records and signatures in pharmaceutical. This term is essential for understanding project development in industrial automation and PLC programming.
Common Questions
What is 21 CFR Part 11?
FDA regulation for electronic records and signatures in pharmaceutical.
What prerequisites are needed to understand 21 CFR Part 11?
As an advanced-level concept, 21 CFR Part 11 requires a solid foundation in PLC fundamentals and intermediate programming concepts. It's recommended to have hands-on experience with Project Development & Documentation before diving deep into this topic.
What are related concepts I should learn?
To fully understand 21 CFR Part 11, you should also familiarize yourself with FAT (Factory Acceptance Test), SAT (Site Acceptance Test), and Commissioning. These concepts work together in industrial automation systems.
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Quick Info
- Difficulty
- Advanced
- Tier
- Advanced
About Project Development & Documentation
Engineering workflows, documentation standards, and project management