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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 in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 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 2 of 10 A computer system is used to prepare a report, but the organisation relies on the final paper report for the regulated activity and the paper report satisfies the applicable predicate-rule requirements. Which conclusion best reflects the article?

The electronic output is automatically a Part 11 record because software was used The paper record may remain the relied-upon regulated record, so the electronic output is not automatically in scope solely because it generated the paper Part 11 applies only to the printer and printing process The organisation must maintain both records as equally authoritative

Question 3 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 4 of 10 What is the key distinction between authentication and authorisation in a pharmacovigilance system?

Authentication determines what a user may do; authorisation determines the user's identity Authentication establishes identity; authorisation determines which actions or records the identified user may access or perform Authentication and authorisation are interchangeable terms Authorisation is required only for system administrators

Question 5 of 10 Why can metadata be important when preserving a pharmacovigilance electronic record?

Metadata are used only for software licensing Metadata may provide identity, timing, version, source, status and relationships necessary to interpret or reconstruct the record Metadata are irrelevant once the main data fields have been exported Metadata replace the need for access control and validation

Question 6 of 10 Which information must be associated with a signed electronic record under the signature-manifestation concept described in the article?

Only the signer's department The signer's printed name, execution date and time, and the meaning of the signature Only the user's login name and computer address The software vendor's name and licence number

Question 7 of 10 An organisation keeps a paper case file but performs medical review and regulatory reporting using the electronic case record. What is the most appropriate interpretation?

Part 11 cannot apply because a paper copy exists The electronic record may fall within Part 11 because it is relied upon for regulated activities Only the paper record is regulated, regardless of actual business practice Both versions are automatically authoritative and must be treated as identical records

Question 8 of 10 A company is deciding whether a PDF export, database record or transmitted XML file is the official pharmacovigilance record. What should it do first?

Select the format that is easiest to print Select the format with the largest file size Define and document which representation is authoritative and which are copies, working outputs or submission artifacts Treat all representations as equally authoritative by default

Question 9 of 10 Which capability is most directly relevant to the accurate-and-complete-copy requirement?

The ability to generate only a screenshot of the current screen The ability to retrieve records in human-readable and electronic forms while preserving necessary content and context The ability to delete older versions after a PDF is created The ability to export only the fields visible to the current user

Question 10 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

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21 CFR Part 11: Electronic Records and Electronic Signatures Explained

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