PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

The Parenteral Drug Association’s (PDA) new report, PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems, is the first in a series of three technical reports that the association plans to publish on data integrity. TR 80 provides the framework and tools necessary to establish a data integrity management system for pharmaceutical laboratories.

Interpreting and meeting health authority expectations for data management and data integrity can be challenging, and laboratory systems can be especially complex due to the combination of manual, hybrid, and automated processing, PDA states. TR 80, which was developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, discusses what is needed to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the laboratory.

The report is intended to outline regulatory requirements and expectations, along with best industry practices, to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation.

Source: Parenteral Drug Association