QUIZ: 21CFR11

Why are measurement files generated by Rudolph’s 21 CFR solution password-protected PDFs? *

To make them easier to email

To comply with industry design trends

To prevent editing, deletion, or removal from the audit trail

To ensure compatibility with Microsoft Word

What happens when the “Enable Review” option is turned on in Rudolph’s 21 CFR software? *

Data is immediately exported to the network upon measurement

A second user must review and approve the data before it is exported

The operator is able to bypass login requirements

The instrument is locked until an IT admin approves the settings

What is the function of the audit trail in Rudolph’s 21 CFR system? *

It records only the final reports that were exported

It logs every action on the instrument and supports keyword and time-based searches

It deletes all data after 30 days for security

It tracks only login and logout events for each user

Which of the following is TRUE about user roles and groups in the 21 CFR software? *

The operator group can change user passwords

Reviewers are allowed to review their own results

Custom groups like "Lab Manager" can be created with specific access rights

All users have equal access to all parts of the instrument software

What is one security feature offered for laboratories that want to use an external PC with Rudolph’s instruments? *

The software disables all network access

The instrument can operate without user credentials

The software can be installed on a PC to comply with internal IT credential protocols

Only USB devices are used for data transfer

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