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21 CFR Part 11: Electronic Records and Electronic Signatures Explained

Test your understanding of the concepts covered by 21 CFR Part 11: Electronic Records and Electronic Signatures Explained.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which event is most likely to represent a Part 11 electronic signature rather than an ordinary user interaction?

Opening a case for viewing Selecting a navigation menu Executing an authorised approval intended to have the significance of a required handwritten signature Receiving an automated system notification

Question 2 of 10 Why is audit-trail review distinct from merely having an audit-trail function?

An audit trail is useful only if its entries are routinely deleted The organisation must define appropriate review triggers, responsibilities, procedures and investigation of suspicious activity Audit-trail review is unnecessary when a system has role-based access The existence of an audit trail proves that all changes were appropriate

Question 3 of 10 A user suspects that their electronic-signature password has been disclosed. What is the most appropriate immediate organisational response?

Continue using the account until the next scheduled access review Share the password with a colleague so work can continue Disable or otherwise secure the credential, investigate potentially affected activity and document the response Delete the user's audit-trail history to prevent confusion

Question 4 of 10 Which statement correctly distinguishes an FDA regulation from FDA guidance in the context of Part 11?

FDA guidance has the same legal status as a regulation Part 11 is advisory, while the 2003 guidance is legally binding Part 11 establishes regulatory requirements, while guidance describes FDA's current thinking and enforcement approach Company procedures override both Part 11 and FDA guidance

Question 5 of 10 A signed validation report is revised after approval. Which control question is most important?

Whether the revised document has the same file name Whether the original approval could misleadingly appear to apply to the revised content Whether the revised document can be printed in colour Whether the document is stored on the same workstation

Question 6 of 10 Which statement best distinguishes an electronic record used internally to prepare an FDA submission from an electronic record submitted to FDA?

Any internal working record that contributes to a submission is automatically submitted electronically A record submitted electronically may fall within Part 11, while an internal source record is not automatically in scope solely because it contributed to the submission Internal records are never subject to Part 11 Only records containing electronic signatures can be submitted records

Question 7 of 10 Which control most directly supports protection of records throughout the required retention period?

Allowing unrestricted overwriting of historical values Preventing accidental deletion, unauthorised alteration, corruption, loss during migration and premature destruction Relying exclusively on users to remember retention dates Printing every record and deleting the electronic source

Question 8 of 10 Which statement best describes validation under §11.10(a) for a closed system?

It demonstrates only that the application can be installed It demonstrates accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records It confirms that every system feature has identical regulatory significance It eliminates the need for procedural controls

Question 9 of 10 Which statement best describes the relationship between Part 11 and predicate rules?

Part 11 replaces predicate rules whenever an activity is performed electronically Predicate rules apply only to paper records, while Part 11 governs all electronic data Predicate rules establish the underlying regulated activity or record, while Part 11 addresses controls for electronic records and signatures used to satisfy that obligation Predicate rules are nonbinding recommendations used to interpret Part 11

Question 10 of 10 A safety database generates many operational data points, including screen-navigation events and temporary system calculations. What is the most appropriate Part 11 assessment approach?

Treat every digital value as an independent Part 11 record Exclude all system-generated information because it was not entered by a person Assess the regulatory significance, intended use and reliance on each relevant record or information set within the business process Treat only information that is eventually printed as a Part 11 record

21 CFR Part 11: Electronic Records and Electronic Signatures Explained

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