Documentation & Record Management Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation & Record Management flashcards as text
A GxP 'raw data' record must meet which primary criterion to be considered acceptable?
Answer: It must be attributable, legible, contemporaneous, original, and accurate (ALCOA)
The ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) define acceptable raw data under GxP regulations.
Which action best describes a 'Good Documentation Practice' (GDP) when correcting a handwritten entry?
Answer: Draw a single line through the error, write the correction, and add date and initials
GDP requires that errors be corrected with a single line so the original entry remains legible, accompanied by the corrector's initials and date.
In the context of eCTD submissions, a 'document lifecycle' most critically requires that:
Answer: Each document version be uniquely identified and linked to its predecessor
eCTD document lifecycle management requires unique version identifiers and relationships between document versions to support regulatory review and post-approval changes.
Under EU GMP Annex 11 (Computerised Systems), what must be ensured for data stored in computerised systems?
Answer: Data must be protected against unauthorized modification and backed up regularly
Annex 11 requires that computerised systems protect data integrity through access controls, audit trails, and regular verified backups.
A 'master document list' in a document management system serves what primary regulatory purpose?
Answer: Providing a single authoritative inventory of all current approved documents and their revision status
A master document list ensures that only the current, approved version of each document is in use and provides a reference for auditors.
Which statement about electronic signatures under 21 CFR Part 11 is CORRECT?
Answer: Electronic signatures must be linked to their respective electronic records and cannot be copied or transferred
21 CFR Part 11.70 requires that electronic signatures be permanently linked to their associated records to prevent falsification through copying.
When preparing a regulatory submission, the principle of 'document traceability' means:
Answer: Requirements, design, testing, and approval records are linked so changes can be traced end-to-end
Traceability matrices link requirements to design outputs and verification activities, allowing regulators to confirm all requirements were addressed.