CRAP Documentation & Record Management 3 — Questions and Answers
Question 1: A GxP 'raw data' record must meet which primary criterion to be considered acceptable?
- It must be typed, never handwritten
- It must be attributable, legible, contemporaneous, original, and accurate (ALCOA) (Correct answer)
- It must be approved by a supervisor within 24 hours
- It must be stored in a cloud-based system
Correct 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.
Question 2: Which action best describes a 'Good Documentation Practice' (GDP) when correcting a handwritten entry?
- Use correction fluid to cover the error, then write the correction
- Draw a single line through the error, write the correction, and add date and initials (Correct answer)
- Tear out the page and rewrite the entire entry
- Leave the error and attach a separate note
Correct 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.
Question 3: In the context of eCTD submissions, a 'document lifecycle' most critically requires that:
- All documents be converted to Word format before submission
- Each document version be uniquely identified and linked to its predecessor (Correct answer)
- Documents be submitted only in English regardless of country
- All authors hold advanced degrees
Correct 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.
Question 4: Under EU GMP Annex 11 (Computerised Systems), what must be ensured for data stored in computerised systems?
- Data must be printed weekly as a backup
- Data must be protected against unauthorized modification and backed up regularly (Correct answer)
- Access must be limited to quality assurance staff only
- System validation is optional for legacy systems
Correct 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.
Question 5: A 'master document list' in a document management system serves what primary regulatory purpose?
- Tracking employee training completion
- Providing a single authoritative inventory of all current approved documents and their revision status (Correct answer)
- Recording external regulatory correspondence
- Managing supplier qualification files
Correct 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.
Question 6: Which statement about electronic signatures under 21 CFR Part 11 is CORRECT?
- An electronic signature does not carry the same legal weight as a handwritten signature
- Electronic signatures must be linked to their respective electronic records and cannot be copied or transferred (Correct answer)
- Only C-suite executives may use electronic signatures on regulatory documents
- Electronic signatures require annual re-certification by the FDA
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.
Question 7: When preparing a regulatory submission, the principle of 'document traceability' means:
- Every document must have a barcode for physical tracking
- Requirements, design, testing, and approval records are linked so changes can be traced end-to-end (Correct answer)
- Documents are translated into all languages of target markets
- All documents originate from a single department
Correct 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.
CRAP Documentation & Record Management 3
A GxP 'raw data' record must meet which primary criterion to be considered acceptable?