Data Integrity: Still a Top FDA Finding
Are You Audit-Ready?

Despite widespread investment in digital systems and automation, data integrity remains one of the most cited issues in FDA inspectional observations. From biotech startups to global pharma companies, lapses in data governance not only risk noncompliance—they also threaten product quality and patient safety.

So why does data integrity remain a persistent challenge? And more importantly, how can companies shift from reactive remediation to a proactive, audit-ready stance?

What the FDA Is Still Finding

A review of 2024 FDA inspection observations[1] reveals that data integrity remains a recurring theme in Form 483s:

  • Incomplete test data: Missing documentation or lack of traceability
  • Record retention noncompliance: Inconsistent or missing record-keeping practices
  • Insufficient data backups: Lack of adequate recovery and continuity planning
  • Weak system controls: Poor safeguards for unauthorized access or modifications

These issues often arise when companies underestimate how digital systems can drift from ALCOA+ principles without proper governance and oversight.

[1] FDA FY 2024 Inspectional Observation Data Set

Revisiting ALCOA+: The Foundation of Data Integrity

Originally developed by the FDA, ALCOA+ provides a globally accepted framework for ensuring data reliability across a product’s lifecycle—especially in digital environments.

As automation and electronic records evolve, ALCOA+ expands on the original five principles to include additional requirements that support data trustworthiness in modern systems.

PrincipleWhat It Means in Digital Systems
AttributableData is linked to the person who created or modified it
LegibleData must be readable and understandable
ContemporaneousRecorded at the time of the activity
Original or a true copy The original record or a verified copy
AccurateFree from error and reflects the true result
CompleteAll data included – even failed, repeated, or invalidated results
ConsistentChronologically ordered and time-stamped
EnduringSecurely stored and protected from loss or alteration
AvailableAccessible throughout the entire retention period

These principles are critical not only for regulatory compliance, but also for supporting transparency, accountability, and ultimately patient safety.

Is Your Organization’s Data Audit-Ready?

Here are six key steps to build sustainable data integrity across your operations:

1.      Map Your GxP Data Flows

Identify where data originates, how it moves, and where it is reviewed and stored. Mapping these flows helps expose potential gaps in compliance and control.

2.      Establish Security and Access Controls

Ensure only authorized personnel can access or modify data. Define and document roles, access levels, and enforce traceable audit trails at every stage.

3.      Use Validated Systems

Implement GxP-compliant systems that are properly validated and capable of maintaining robust audit trails, security, and control throughout the data lifecycle.

4.      Define Retention, Backup, and Recovery Plans

Maintain documented retention policies. Assign ownership for backup and recovery procedures to ensure data continuity during system failures or emergencies.

5.      Promote Accountability Through Training

Train employees to understand how their actions affect data integrity. Reinforce ALCOA+ principles and emphasize the importance of early issue reporting.

6.      Document Everything

Ensure all SOPs, system configurations, backup protocols, and audit trail procedures are clearly documented, regularly reviewed, and fully trained on.

How Partnering with Celito Can Help You Get Audit Ready

Building an audit-ready data integrity framework takes time and expertise. Celito helps life sciences organizations streamline and strengthen their compliance programs through:

  • Gap Assessments: Uncover weaknesses in data governance, system controls, and SOPs
  • Process Optimization: Align workflows with ALCOA+ while avoiding unnecessary complexity
  • System Validation and Selection: Guide the implementation of fit-for-purpose, compliant platforms
  • Policy and SOP Development: Develop scalable documentation aligned with your tech stack
  • Change Management and Training: Drive adoption through targeted education and stakeholder engagement

Whether you’re preparing for your first audit or modernizing legacy systems, Celito brings the experience and insight needed to support long-term inspection readiness.

From Compliance Burden to Strategic Advantage

Data integrity is more than a compliance requirement—it’s a foundation for trust, quality, and operational excellence. As regulators sharpen their focus on digital records, life sciences organizations must evolve from reactive remediation to proactive data governance.

True audit-readiness requires more than tools. It demands a culture of accountability, validated systems, and practical controls rooted in ALCOA+ principles.

Whether you’re scaling operations, adopting new technologies, or seeking to close compliance gaps, investing in data integrity now safeguards your products, your patients, and your long-term success.