Testing for Data Integrity and GDP

What does the first 'A' in ALCOA+ represent?

• Accurate

• Attributable

• Available

• Automated

Which principles are supplemented by the '+' in ALCOA+? (Multiple choice)

• Integrity

• Consistency

• Durability

• Traceability

Which of the following are data integrity issues? (Multiple choice)

• Using sticky notes to record temporary data

• Deleting original records without stating reasons

• Recording experimental data in real time

• Not retaining originals after transcribing data

When a data integrity issue is discovered, who should the employee notify first?

• Direct manager or quality management

• External audit agency

• Customer

• IT department

What are the goals of data governance? (Multiple choice)

• Ensure data integrity

• Only applicable to paper records

• Cover the entire data lifecycle

• Only need to manage at the creation stage

What is the correct way to handle blank fields?

• Signature/date

• Crossed out with a line

• Leave blank

• Mark 'N/A' in a single field and sign/date

What is the correct way to correct errors in paper records?

• Cover the error with correction fluid

• Cross out the error and note initials, date, and reason

• Re-write and destroy the original record

• Directly overwrite the erroneous content

What can original records be? (Multiple choice)

• Bound laboratory notebooks

• CSV files generated by electronic systems

• Thermal paper printed charts

• Handwritten sticky notes

How should thermal paper printed original records be handled?

• Directly archived

• Copy and save both the copy and the original

• Scan as a PDF file

• No special handling required

What is the correct practice for recording dates and times? (Multiple choice)

• Use '30-Sep-2024' format

• Midnight recorded as '24:00'

• 12-hour format must indicate 'AM/PM'

• Timestamps do not need calibration