How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaSCloud 2018 is a course dedicated to the specific requirements associated with local and SaaS/cloud hosting solutions.
How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaSCloud 2018 covers topics such as:
- Avoiding 483 and Warning Letters
- What is expected in 21 CFR Part 11 and Annex 11 inspections
- Implementing a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
- How to buy COTS software and qualify vendors
- How to select resources and manage validation projects
- Requirements for local, SaaS, and cloud hosting
- Minimizing the validation documentation to reduce costs without increasing regulatory or business risk
- "Right size" change control methods that allows quick and safe system evolution
- Protecting intellectual property and keep electronic records safe
- Writing test cases that trace to elements of risk management
