ALCOA+ (ALCOA Plus) Data Integrity Principles: Complete, Consistent, Enduring & Available

Learn how ALCOA+ (ALCOA plus) data integrity principles—Complete, Consistent, Enduring, and Available—ensure reliable, audit-ready pharmaceutical data throughout its lifecycle.

Complete

Under ALCOA+ (ALCOA plus) principles, data is considered complete when it captures the entire, uninterrupted history of an activity. This means nothing is missing—no successful results, failed attempts, or repeated actions should ever be deleted or left out after documentation begins.

Seeing the Full Picture:
Completeness goes beyond the final outcome. It includes raw data, associated metadata, and every change made throughout the data lifecycle. Each step tells part of the story, and removing even one piece can compromise data integrity.

Audit Trails Matter:
To meet this requirement, electronic systems must rely on secure audit trails. These trails record every interaction with the data, ensuring transparency and preventing hidden edits that could undermine trust in the dataset.

Consistent

Consistency ensures that data follows a logical, chronological sequence that can be clearly reconstructed during audits. Within the ALCOA+ (ALCOA plus) framework, every data entry, modification, or deletion must align with a defined timeline.

Sequential Integrity:

Records should be created in the correct order, supported by synchronized timestamps. This proves that processes were performed exactly as outlined in the approved Standard Operating Procedures (SOPs).

Built-In Self-Correction:

Regular self-inspections and data audits help maintain consistency. These checks confirm that data collection and storage methods remain uniform across departments, systems, and time periods.

Enduring

The Enduring principle of ALCOA+ (ALCOA plus) focuses on data longevity. Records must remain intact, readable, and reliable for the full retention period—which in regulated industries like pharmaceuticals can span decades.

Physical Records:

For paper-based data, endurance means using durable materials and permanent ink that won’t fade, smudge, or deteriorate over time.

Digital Preservation:

Electronic records must remain accessible despite software updates or hardware changes. This requires strong backup systems, controlled access, and well-planned data migration strategies to prevent loss or corruption.

Available

Data has little value if it can’t be accessed when required. Availability ensures that records are retrievable, understandable, and usable whenever they are needed for audits, inspections, or decision-making.

Immediate Accessibility:

Whether responding to an FDA inspection or conducting an internal quality review, data should be available without unnecessary delays or technical barriers.

End-to-End Lifecycle Management:

From creation to archival and final disposal, availability must be maintained. This means organized storage, clearly defined retention policies, and properly managed digital permissions throughout the data lifecycle.