In the fast-evolving world of life sciences, ensuring the integrity of GMP records has never been more critical. Regulatory bodies like the FDA and EMA continue to emphasize data integrity as a cornerstone of GxP compliance, with ALCOA+ or ALCOA++ principles serving as a guiding framework.
Whether you’re transitioning to manufacturing operations, implementing serialization systems, or embracing risk-based approaches, understanding and mitigating uncovered data integrity issues is essential to patient safety and product quality.
Here, we’ll delve into the most common data integrity issues we found in 2024 and offer insights to strengthen your compliance strategies for 2025.
Data integrity issues typically fell into the categories below:
Governance and SOP Weaknesses:
Insufficiently detailed procedures to guide data and record activities
High-level audit trail review instructions only, leading to inconsistency across reviewers
Uncertainty on how to confirm access for the right role at the right time, including user role changes
Uncertainty on how to confirm vendor activities when they may have elevated roles in the system
Poor instructions describing static and dynamic data, with over reliance on printed reports rather than original electronic record review
Inadequate procedures for end-to-end backup and restore processes
Missing or Outdated Procedures
Absent procedures for managing data across the full data lifecycle with backups described in detail but restore procedures falling short of the mark
Referenced templates or forms used to manage data activities that are missing or obsolete
Backup, Restore, and Disaster Recovery Validation Deficiencies
Insufficient validation of production ecosystems, including use of network or cloud solutions to manage short and long term data storage
Validation of backup and restoration mechanisms performed but only to discrete drives with no real challenges considered such as full DB backup, single file backup, AT record backup or configuration setting backup and no end to end attempt to restore and confirm restored files beyond a volume or integrity check
System Inventory Gaps
Outdated or incomplete inventory lists, leading to uncontrolled data and records
Retired systems not appropriately tracked but still containing GxP-relevant data
Records missing key ALCOA++ Attributes
The good news is that missing records did not feature largely during our inspections. The bad news is that insufficient data attributes to provide data integrity assurance are still an issue.
Main offenders included
Poor or No Attribution of activities: Lack of segregated roles, use of generic accounts leading to confusion of who had actually completed GMP activities
Poor or No Legibility: Overwritten or altered records and no justification recorded for changes made or audit trails disabled with no explainable reason
Questionable Accuracy: Uncontrolled data transformations and manual calculations performed without independent oversight.
Data Transformation Errors
Unverified transformations compromised accuracy
Transformation tools used with no version or coding controls
Physical and Logical Security Issues
Governance and controls associated with physical records continue to be an issue with archive rooms left open or insufficient logging controls around removal and additions to the archive facility
The biggest issue associated with logical controls continues to be generic accounts use and often these generic accounts being used by vendors
To address these issues, site leadership teams, IT and quality directors and data stakeholders must adopt proactive measures
Enhance Training: Ensure that all staff understand the importance of ALCOA++ principles and their practical application
Regularly Revise SOPs: Regularly review and update procedures to include detailed instructions for audit trails, backup and restore, system and data lifecycle management
Conduct Regular Audits and Assessments: Perform internal data integrity audits and GEMBA walks to identify and address gaps
Leverage Technology: Implement GxP-compliant systems that streamline audit trail reviews, data security exception reporting, and lifecycle management
Maintain a Centralized Inventory: Use validated tools to manage system inventories and ensure retired systems are monitored appropriately
Data integrity remains a top priority for life sciences organizations navigating complex regulatory landscapes. By addressing governance weaknesses, enhancing SOPs, and leveraging robust systems, it is possible to ensure GxP compliance and audit readiness.
Are you ready to strengthen your data integrity practices? Sign up for one of ERA Sciences’ comprehensive data integrity courses and equip your team with the knowledge and tools to safeguard patient safety and regulatory compliance. Or simply reach out to one of our data integrity experts and start the success conversation today.
Contact us at info@erasciences.com