SQA SQA Documentation and Record Management 3

Question 1

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

Accepted Answer

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

Answer

Records must be completed and reviewed within 24 hours of an activity

Answer

Data must be witnessed by a second analyst immediately after recording

Answer

Records must be typed rather than handwritten for clarity and legibility

Question 2

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

Accepted Answer

Attributability (the 'A' in ALCOA)

Answer

Accuracy of the data recorded

Answer

Contemporaneousness of the data entry

Answer

Originality of the record created

Question 3

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

Accepted Answer

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

Answer

Only when the original paper record has been damaged beyond all legibility

Answer

Whenever an EDMS is used to store any document in the quality system

Answer

Only for records that are older than the required five-year retention period

Question 4

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

Accepted Answer

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

Answer

The permanent deletion of outdated documents from the document management system

Answer

The issuance of a new document with a different title covering the same subject area

Answer

The merging of two existing approved documents into a single consolidated document

Question 5

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

Accepted Answer

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

Answer

Increasing the time required to complete batch release documentation

Answer

Requiring additional retraining for analysts who make transcription mistakes

Answer

Violating instrument qualification requirements for specific instrument types

Question 6

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

Accepted Answer

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

Answer

A digital backup server used for storing electronic records offsite

Answer

A room where active batch records are stored during ongoing manufacturing operations

Answer

A system for indexing and cross-referencing all quality documents by subject