Four Steps to Ensuring Data Integrity for BET
Data integrity has been well established as a fundamental regulatory expectation under cGMP. Naturally, data integrity also applies to bacterial endotoxin testing (BET).
Tests with BET products generate results in three different methodologies: (a) those that use data generated in electronic form via equipment/software combinations (e.g., chromogenic and turbidimetric products); (b) those that are documented on paper-based systems (e.g., Gel-Clot products); and (c) those that involve hybrid records. Data integrity controls are expected across the product lifecycle for all BET assays in all three formats, starting from data creation, through processing and use, to retention and retrieval. The U.S. FDA data integrity guidance issued in April 2016, along with PIC/S and MHRA documents, encourages the adoption of risk-based approaches to data integrity.