A GLANCE AT DATA INTEGRITY

A GLANCE AT DATA INTEGRITY Data Integrity is a cornerstone of the Quality Culture. The specific culture of an organization is connected to the veracity and accuracy of the data generated to support the quality of manufactured products. Its utmost importance to establish and maintain confidence in the data's reliability, ensuring product quality and patient safety. The manufacturing production and data control reliability is based on the systems, processes, procedures, and controls that provide data integrity. Site metrics, including the on-time rate, reveal the Site Quality culture. (i.e., lot acceptance rate, product quality complaint rate, invalidated out-of-specification (OOS) rate, annual product review, or product quality review). The senior management engagement in corrective actions and preventive actions (CAPA) effectiveness, and process capability/performance complement the Organization's Quality Culture picture. In addition, the organization needs to take responsibility for the systems used and their generated data utilizing the ALCOA Plus principles. Management should aim to create a work environment (i.e., quality culture) that is transparent and open, one in which personnel is encouraged to communicate failures and mistakes freely. In addition, an organizational reporting structure should permit the information flow between personnel at all levels, and the performance indicators should drive the personnel behavior improvement. The data governance policy (or equivalent) should be endorsed at the highest levels of the organization. This approach will allow Senior Management to accurately understand risks and provide the necessary resources to achieve the Regulator's and Company's expectations and meet data quality standards. Auditors should determine if the Organization/Site Quality Culture is conducive to generating data that meets the ALCOA Plus concepts when evaluating the suitability of a manufacturer, potential partner, or service provider.

Unintended

Memory Failure

Error caused by taking no action, e.g., failure to perform a routine task due to forgetting its place in the sequence

Attention Failure

Error caused by taking the wrong action, e.g., unfocused state of mind or a frequently performed action goes wrong or multitasking or aggressive deadlines

Knowledge Gap

Error caused by knowledge gaps in how to perform a task, e.g., lack of or inadequate training

Procedure Gap

Error caused by gaps in rules stating what tasks should be performed and by whom, e.g., lack of or inadequate standard operating procedures (SOPs)

Misconduct

Violations are caused by knowingly ignoring procedures or controls due to misplaced priority, e.g., ignoring established controls to compensate for an aggressive target or time pressure

Intended

Fraud

Violations caused by malicious intent to perform a fraudulent act, e.g., falsifying data for personal gain or avoiding personal pain

Fraud

Violations caused by malicious intent to perform a fraudulent act, e.g., falsifying data for personal gain or avoiding personal pain