Myths
In addition to electronic records created by computerized systems, what other records apply to Data Integrity requirements?
Data Integrity requirements apply to both electronic records and paper records
The first step in the data life cycle?
Data generation
Name the electronic record that automatically records operator identity and certain operator actions along with a date and time stamp
Audit trail
Who is responsible for maintaining metallurgical balances
Plant Metallurgists
Quality management
Data Integrity is only necessary to address the intentional falsification of data commonly (and legally) referred to as this
Fraud- the truth is data integrity is intended to address risks associated with not only intentional falsification of data but also the accidental errors and omission.
What step includes verification of the lab's ability to accurately retrieve and restore data?
Data management
What is the name for a copy of current (editable) data, metadata and system configuration settings (variable settings which relate to an analytical run) maintained for the purpose of disaster recovery?
BACK-UP
What is the data system that is used to store all assay data.
Lims or the Data Repository (Power BI)
What is the difference between QA and QC?
QA provides confidence that quality requirements will be fulfilled.
QC is fulfilling quality requirements.
Most People believe that the root cause of data integrity errors is this
Human- the truth is that human error is not a root cause. we must ask why the person made the error and continue asking why until we uncover the true root cause
Which step are calculations performed using a spreadsheet, calculator or software to generate a final result?
Data processing
Using a unique logon and password to create this on an electronic record?
Your electronic signature
Name three KPI's that are looked at during End of Month Reporting.
Recovered Ounces
Percent Recovery
Tons Processed
How often and when is QA conducted
Conducted as often as a Quality Management Plan calls for and is done after QC is complete but before submission
Data integrity issues occur mainly in this country
China- the truth is that data integrity issues have been seen everywhere including the US and EU
Significant figures and rounding rules are most applicable in this step
Data processing
What kind of control automatically locks the user out of the computerized system after a defined period of inactivity?
Technical or logical control
Unreconciled vs Reconciled Pulp call should be with in what percentage threshold for SOX Compliance
10% monthly
5% rolling 3-month
3% rolling 12-month
How often and when is QC conducted
Continuously occurring process on all projects and submittals
Third parties are solely responsible for the quality of their own data
False - Whether it was created internally or not, it is critical to verify and maintain data quality across all data sources
Disposal of original records
Data Destruction
Failure to follow procedures for data integrity may require you to create one of these
Deviation
What is SOX Compliance
Checks on Accuracy and Accounting
In 2002, the United States Congress passed the Sarbanes-Oxley Act (SOX) to protect shareholders and the general public from accounting errors and fraudulent practices in enterprises, and to improve the accuracy of corporate disclosures.
Developing rules, guidelines, procedures, limits or other protocols for directing the work and processes of employees and departments are examples of what type of control to ensure data integrity?
Organizational Control