What exactly is required for 21 CFR Part 11 compliance?

This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).

Areas Covered in the Seminar:

• Which data and systems are subject to Part 11.
• What Part 11 means to you, not just what it says in the regulation.
• Avoid 483 and Warning Letters.
• Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
• Ensure data integrity, security, and protect intellectual property.
• Understand the current computer system industry standards for security, data transfer, and audit trails.
• Electronic signatures, digital pens, and biometric signatures.
• SOPs required for the IT infrastructure.
• Product features to look for when purchasing COTS software.
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

Who Will Benefit:

• Computer System users
• IT
• QA
• Managers