Data Integrity: History, Issues, and Remediation of Issues

Area of Science:

• Pharmaceutical industry regulations
• Data management in drug development
• Regulatory compliance

Background:

• The U.S. Food and Drug Administration (FDA) and European Union (EU) have established numerous guidelines for data integrity in the pharmaceutical sector since 1963.
• Regulatory bodies aim to ensure accurate data capture throughout the drug development lifecycle and commercialization.
• Increased warning letters globally highlight the importance of data integrity.

Observation:

• The FDA defines electronic data expectations using the acronym ALCOA: Attributable, Legible, Contemporaneous, Original, and Accurate.
• ALCOA has been expanded to ALCOA Plus, incorporating Enduring, Available and Accessible, Complete, Consistent, Credible, and Corroborated.
• Non-compliance with data integrity regulations poses significant risks to pharmaceutical companies.

Findings:

• This article reviews the historical evolution of data integrity regulations from various bodies.
• It details the ALCOA Plus principles and the consequences of non-adherence.
• Prevention strategies, including checklists, self-audits, and self-inspections, are discussed.

Implications:

• Implementing robust data integrity practices is essential to mitigate risks and ensure regulatory compliance.
• A strategic approach involving people, processes, and technology is necessary for effective data lifecycle management.
• Failure to maintain data integrity can lead to drug non-approval, revenue loss, and unavailability of medications for patients.