SQA Data Integrity and Electronic Records 2

Question 1

The ALCOA+ framework expands the original ALCOA principles with additional attributes. Which of the following is part of ALCOA+?

Accepted Answer

Complete, Consistent, Enduring, and Available

Answer

Certified, Controlled, Encrypted, and Authorized

Answer

Compliant, Classified, Executable, and Archived

Answer

Corroborated, Confirmed, Enhanced, and Audited

Question 2

According to GLP regulations (21 CFR Part 58), what is the minimum retention period for raw data and specimens from a non-clinical safety study submitted to the FDA?

Accepted Answer

At least 5 years after the date the study is completed, discontinued, or terminated

Answer

At least 2 years after FDA approval of the related drug

Answer

At least 10 years from the date the study begins

Answer

At least 1 year after the submission of the final study report

Question 3

What is the primary goal of Computer System Validation (CSV) in a GLP laboratory?

Accepted Answer

To demonstrate that a computer system consistently produces results meeting predetermined specifications and quality attributes

Answer

To ensure all laboratory staff are trained to use the software

Answer

To back up all electronic records to a secondary server weekly

Answer

To verify that the computer system connects to the internet securely

Question 4

In the ALCOA framework, what does 'Complete' mean when applied to GLP data?

Accepted Answer

All data, including original observations, deviations, and corrections, must be present without any omissions

Answer

A final study report has been written and signed by the study director

Answer

All samples have been analyzed and results entered into the database

Answer

The data has passed statistical analysis and quality review

Question 5

What is metadata in the context of electronic GLP records?

Accepted Answer

Data that describes the context, content, and structure of a primary record, such as time stamps, user IDs, and instrument settings

Answer

A summary table of key results included in the final study report

Answer

The electronic signature applied to a completed data set

Answer

A backup copy of original data stored in a separate archive

Question 6

Under 21 CFR Part 11, before an organization can use electronic records in place of paper records, it must ensure which of the following?

Accepted Answer

Systems are validated, access controls are in place, audit trails are active, and records can be accurately reproduced

Answer

All employees have completed a 40-hour computer training course

Answer

Paper records are destroyed after electronic entry is completed

Answer

The electronic system has received FDA pre-approval before use

Question 7

In GLP studies, what is the key distinction between raw data and a final study report?

Accepted Answer

Raw data is the original recorded observation or result; the final report is a summarized interpretation of all data presented to management or regulators

Answer

Raw data is only generated by automated instruments; the final report is handwritten by the study director

Answer

Raw data must be destroyed once the final report is approved

Answer

The final report is always more accurate than raw data due to editorial review