Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it 2015 covers topics such as:
- Procedures that are to be followed and discuss all of the documentation that is to be prepared to meet the requirements of this regulation
Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it 2015 brings together:
- Users of the computer systems
- IT Staff implementing and supporting these computer systems
- Vendors of these "Regulated "computer systems
- Quality Assurance Staff faced with auditing computer systems