CRAP Documentation & Record Management 3

Question 1

A GxP 'raw data' record must meet which primary criterion to be considered acceptable?

Accepted Answer

It must be attributable, legible, contemporaneous, original, and accurate (ALCOA)

Answer

The ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) define acceptable raw data under GxP regulations.

Question 2

Which action best describes a 'Good Documentation Practice' (GDP) when correcting a handwritten entry?

Accepted Answer

Draw a single line through the error, write the correction, and add date and initials

Answer

GDP requires that errors be corrected with a single line so the original entry remains legible, accompanied by the corrector's initials and date.

Question 3

In the context of eCTD submissions, a 'document lifecycle' most critically requires that:

Accepted Answer

Each document version be uniquely identified and linked to its predecessor

Answer

eCTD document lifecycle management requires unique version identifiers and relationships between document versions to support regulatory review and post-approval changes.

Question 4

Under EU GMP Annex 11 (Computerised Systems), what must be ensured for data stored in computerised systems?

Accepted Answer

Data must be protected against unauthorized modification and backed up regularly

Answer

Annex 11 requires that computerised systems protect data integrity through access controls, audit trails, and regular verified backups.

Question 5

A 'master document list' in a document management system serves what primary regulatory purpose?

Accepted Answer

Providing a single authoritative inventory of all current approved documents and their revision status

Answer

A master document list ensures that only the current, approved version of each document is in use and provides a reference for auditors.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Documentation & Record Management 3