Differences between ALCOA ALCOA+ and ALCOA++

1. ALCOA

Definition: A foundational set of principles for data integrity in regulated industries (FDA, EMA, MHRA, WHO, PIC/S).

Core Five Elements:

• A – Attributable → Who did it, when, and why.
• L – Legible → Readable and permanent.
• C – Contemporaneous → Recorded at the time of activity.
• O – Original → First capture or certified true copy.
• A – Accurate → Error-free and truthful.

Focus: Establishes the minimum acceptable standard for trustworthy data.

2. ALCOA+

Definition: An extension of ALCOA, introduced as regulatory expectations grew.

Adds Four More Attributes:

• Complete → Nothing missing; all data (including repeats, outliers, corrections) must be included.
• Consistent → Data entries must follow a logical sequence and standardized format.
• Enduring → Data must be maintained in durable, tamper-proof systems (not temporary notes).
• Available → Data must be easily retrievable during audits or inspections.

Focus: Ensures data is comprehensive, sustainable, and accessible over its lifecycle.

3. ALCOA++

Definition: The evolved, mature model of data integrity, used by advanced organizations and aligned with WHO, EMA, and digital governance frameworks.

Adds Further Dimensions:

• Traceable → Full audit trails for every action.
• Transparent → Open, honest data practices; no hidden manipulations.
• Trustworthy → Builds regulator and patient confidence.
• Ethical → Embeds data integrity into corporate culture.
• Governance & Digital Integration → Cloud, AI, blockchain, and advanced data systems incorporated.

Focus: Moves beyond compliance → fosters a culture of integrity + modern digital readiness.

Comparison Table