At the Annual ISPE Meeting, I also attended the presentation titled “Data Integrity Trends: Regulatory and Compliance Perspective.”
Karen Takahashi, Senior Policy Advisor, FDA/CDER/OPPQ/DRGS/Co., laid down the foundation for this discussion with her talk on the controls and expectations of data integrity.
Some of her key points were as follows:
- Data integrity is the requirement for complete, consistent, and accurate data. It is a fundamental component of information security.
- We rely on accurate information to ensure drug quality.
- Not only does your information need to be accurate, but contractors’ data needs to be accurate and reliable as well.
- All data for each batch should be retained.
- Personnel should not be able to delete, alter, or overwrite data.
- Raw data should match data in reports.
- Always be sure to verify the authenticity of your data as well as the authenticity of your contractor’s data.
Following Takahashi, David Churchward, Expert GMP Inspector, MHRA, dove into data integrity trends and perspectives. According to Churchward, some of the underpinning problems of data risks include incentive, opportunity, rationalization, and outdated control measures. He also noted—interestingly enough—that concerns with data integrity is largely due to error rather than fraud.
In his discussions, Churchward detailed a data lifecycle:
With this data lifecycle in mind, it is important to consider the specific areas of vulnerability that may need to be addressed. Churchward also detailed a data integrity action plan:
Toward the end of the presentation, Churchward gave a few calls to action and cautionary words of guidance:
- Understand that problems with data integrity can happen at your facility.
- Be prepared to challenge the existing culture.
- Be prepared to address organizational behavior.
- Consider an open reporting culture.
- Leadership needs to be involved—specifically to communicate realistic expectations. They also need to understand the importance of reliable data and be willing to trust employees.
“Perfection is the barrier to progress,” said Churchward. “It’s like painting the living room while your kitchen is on fire.”
And with that wonky imagery bopping around your skull, I shall leave you.
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