GxP Regulated Firms And The Importance Of Data Integrity — Part 1
This article discusses GxP Data integrity, which is applicable to BioPharma Cold Chain in multiple areas, such as electronic temperature measurement data from dataloggers:
Regulatory agencies have cited deficiencies in GMP data integrity and data management for at least the past 15 years. Yet it appears that the industry as a whole has made limited progress in recognizing and remediating these deficiencies. Regulators continue to identify the same set of shortcomings, including but not limited to: shared passwords, lack of enabled audit trails, failure to review electronic data, failure to review and investigate all failed testing results, and failure to contemporaneously record information, just to name a few. Perhaps this is due to a lack of awareness regarding requirements for electronic records, or more likely, firms may assign all computer and software system responsibilities to the IT groups without engaging a knowledgeable quality unit and other stakeholders as active partners. Failure to integrate assessments of data management and data integrity into internal GMP audit programs perpetuates inadequate practices. Waiting for regulatory authorities to identify poor practices and procedures is never a sound strategy.
In this three-part series, I will provide a structured look at the topic and include links to relevant documents, as well as an extensive list of primary references. You will learn about the regulatory enforcement background and why we’ve arrived at the point where data integrity is such a significant focus, the applicable regulations and guidance and the enforcement actions taken by global regulatory authorities in this area, and what actions you can take within your own company to begin to address the topic.
Source: BioProcess Online
