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The Role of Information Systems in 21 CFR Part 11 Compliance: What You Should Know
The FDA has issued Title 21 CFR Part 11 in response to the potential security risks of electronic record keeping. However, trying to ensure compliance with the complex regulations in Part 11 can feel like an uphill battle – especially when legacy systems are involved.
This resource introduces an integrated enterprise resource planning (ERP) suite that supports electronic records and signatures compliant with Part 11. Read on now to discover:
- An overview of Part 11 requirements
- Enforcement of Part 11 regulations
- Implementing enabling technology
- And more