SQA Documentation and Record Management Flashcards

What is the significance of 'contemporaneous' record-keeping in a GLP/GMP environment?

Answer: Data must be recorded at the time the activity is performed, not reconstructed later from memory

Contemporaneous recording means data is captured at the moment of observation — pre-dating or backdating records is a serious GxP violation and a data integrity breach.

Which GxP principle requires that a record can be traced to the individual who created or modified it?

Answer: Attributability (the 'A' in ALCOA)

Attributability requires that every data entry or record modification can be definitively linked to the person who made it through initials, signatures, or unique user IDs.

When may a company use 'true copy' provisions to replace original paper records?

Answer: When the copy is a verified, accurate reproduction of the original that preserves all original information and the process is validated and documented

A true copy is an exact reproduction of an original record verified for accuracy; the true copy process must be documented and validated to be acceptable under GxP.

What is 'document supersession' in a controlled document management system?

Answer: The process by which a new version of a document replaces and obsoletes the previous version

Supersession is the formal replacement of an older document version by a newer approved version, with the old version archived and marked as obsolete.

What is the primary risk of data transcription errors in a GxP laboratory?

Answer: Introducing inaccuracies when copying data between records, potentially leading to incorrect quality decisions

Transcription errors can result in release of non-conforming product or failure to detect quality problems when data is manually copied between records.

What is a 'GxP Archive' and what are its key requirements?

Answer: A secure, controlled facility where records are stored to protect them from deterioration, loss, or unauthorized access during the retention period

A GxP archive is a designated controlled storage area (physical or electronic) that protects records from deterioration, unauthorized access, and loss for the required retention period.