SQA Data Integrity and Electronic Records 3

Question 1

What is the primary purpose of a data governance framework in a GLP-regulated laboratory?

Accepted Answer

To define policies, responsibilities, and controls that ensure data integrity throughout the data lifecycle

Answer

To restrict laboratory access to only senior researchers and management

Answer

To determine which studies require electronic versus paper record-keeping

Answer

To establish pricing for data storage infrastructure contracts

Question 2

Which of the following laboratory practices is a clear violation of GLP data integrity principles?

Accepted Answer

Recording instrument readings on a scrap of paper and transcribing them into the study record later without noting the original source

Answer

Using a validated Laboratory Information Management System (LIMS) to capture analytical results directly

Answer

Performing duplicate analyses when the first result is out of specification

Answer

Archiving electronic raw data on a secure, access-controlled server

Question 3

In the ALCOA framework, what does 'Attributable' require for a GLP data record?

Accepted Answer

It must be possible to identify who performed each action and when, linking data to the responsible individual

Answer

The data must be assigned to a specific regulatory category before archiving

Answer

The study director must personally sign every page of raw data

Answer

All data must be attributed to the sponsor in the final report

Question 4

What is the role of the Quality Assurance (QA) unit in ensuring data integrity in a GLP facility?

Accepted Answer

To independently audit study records and processes to verify compliance with GLP regulations and SOPs, and report findings to management

Answer

To generate raw data alongside study personnel to provide a check on accuracy

Answer

To approve all electronic systems before laboratory staff can use them

Answer

To archive all raw data at the conclusion of each study

Question 5

Under GLP regulations, what are the requirements when correcting an error in a paper raw data record?

Accepted Answer

The error must be crossed out with a single line, keeping the original legible, and the correction must be initialed, dated, and a reason provided

Answer

The entire page must be voided, a new page created, and both signed by the study director

Answer

The incorrect entry must be erased or covered with correction fluid before writing the correct value

Answer

The correction must be made in red ink to distinguish it from the original entry

Question 6

Why are time stamps critical to the integrity of electronic GLP records?

Accepted Answer

They provide objective, system-generated proof of when data was created or modified, supporting the contemporaneous and attributable requirements of ALCOA

Answer

They allow laboratory management to calculate how long each test procedure takes

Answer

They automatically synchronize data between different laboratory systems

Answer

They determine which regulatory agency has jurisdiction over the study

Question 7

When a GLP laboratory migrates records from one electronic system to another, what is the most critical data integrity requirement?

Accepted Answer

Verifying that all data, including metadata and audit trails, is completely and accurately transferred without loss or corruption

Answer

Deleting the old system immediately after transfer to prevent duplication

Answer

Printing all electronic records to paper before migrating to the new system

Answer

Having the sponsor review and approve all migrated data before use