21 CFR Part 11, Interview Questions and Answers | Electronic Records & Signatures | PART 1 of 2

Описание: This video is about 21 CFR Part 11, Interview Questions and Answers | Electronic Records & Signatures | PART 1 of 2

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21 CFR Part 11, Interview Questions and Answers | Electronic Records & Electronic Signatures


Part 1

1.            What are the requirements of 21 CFR 11?

2.            What computer systems must be compliant with 21 CFR 11?
3.            What is computer system validation?


4.            What is accurate record generation?

5.            How must records be protected?

6.            What is limited system access?

7.            What is an audit trail?

Part 2

1.            What are operational system checks?

2.            What are device checks?

3.            What training requirements are required for 21 CFR 11 compliant programs?

4.            What is a policy of responsibility for using electronic signatures?

5.            What documentation requirements are required for 21 CFR 11 compliant programs?

6.            What are the requirements for electronic signatures?


7.            Does 21 CFR 11 have any requirements for passwords or identification codes?




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