21 CFR Part 11 Data Integrity for Online TOC Instruments

A recent report suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry cited deficiencies in their data integrity*. Despite guidance from the FDA, TOC monitoring remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data. In their 21CFR part 11 ALCOA guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current TOC monitoring practices and shows how the FDA guidance can be applied to improve data integrity. Fortunately an ALCOA compliant solution exists. The ANATEL PAT700 TOC and Conductivity analyser from Beckman Coulter automates all SOPs, eliminates manual data entry and calculations and creates an electronic record straight from the analyser. Signatures are attributable and controlled by the site IT team using Microsoft’s Active Directory controls. The record is legible being in one of the recommended formats from the FDA, PDF.  The record is contemporaneously created it is the original record and is transmitted via Ethernet to the site’s secure server where the final records are kept. The SOPs for calibration and system suitability are built in and automated.  There is no manual data entry as the analyser reads the certified values form the standards bottles using RFID technology. This collapses the workflow and removes all manual steps, thus reducing the opportunities for human error and making the record accurate.