How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud 2020 is a conference that provides knowledge on how to buy COTS software and qualify vendors.
How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud 2020 covers topics such as:
- Computer system using risk -based validation to gain maximum productivity and reduce cost by as much as two thirds
- 483 and Warning Letters
- What is expected in 21 CFR Part 11 and Annex 11 inspections
- How to buy COTS software and qualify vendors
- How to resources and manage validation projects
- Requirements for local, SaaS, and cloud hosting
- The validation documentation to reduce costs without increasing regulatory or business risk
- "Right size" control methods that allows quick and safe system evolution
- Intellectual property and keep electronic records safe
- Test cases that trace to elements of risk management