What is ALCOA? The Foundation of Data Integrity in Pharmaceuticals

In the world of pharmaceuticals,

Data integrity = product quality + patient safety.

That's why every single data entry - from batch records to lab results - must follow one powerful principle: ALCOA+

Originally, ALCOA was developed by the FDA to ensure data integrity in pharma. Later, it was expanded into ALCOA+ to cover more aspects.

ALCOA Principles

A – Attributable → Who did it and when? (signed/initialed, dated)

L – Legible → Clear, readable, permanent (no overwriting, proper corrections)

C – Contemporaneous → Recorded at the time work was performed

O – Original → First capture of data (raw data, not copied) or true verified copy

A – Accurate → Error-free, truthful, reflects actual observation or True reflection of facts

The “ALCOA+” Expansion

Complete → All data included (not just passing results)

Consistent → Date/time order, logical sequence

Enduring → Long-term preservation (paper/electronic, durable)

Available → Accessible for review/audit at any time

The “ALCOA++” Expansion

Access-controlled: Only authorized personnel can modify or view.

Available when needed: Data must be accessible anytime for verification.

The “ALCOA+++” Expansion

Traceable: Every change must be traceable via audit trail.

Transparent: Processes must be open and reviewable.

Trustworthy: Foster a culture of honesty and accountability.

Why ALCOA+ Matters

1. Prevents data manipulation or falsification
2. Builds trust in lab and manufacturing records
3. Ensures compliance with GLP/GMP/cGMP
4. Protects patients → because bad data = unsafe medicines

ALCOA+ is not just a checklist—it’s the backbone of data integrity in GLP and GMP.

Why ALCOA+++ Matters

1. Ensures data integrity across all operations.
2. Aligns with GMP, FDA, EMA, MHRA, and WHO expectations.
3. Protects patient safety by ensuring product quality.
4. Promotes audit readiness and compliance confidence.
5. Builds a strong quality culture within your organization.

Remember:

"If your data is not reliable, your product cannot be trusted."

Implement ALCOA+++ in every document, every record, and every operation — because quality begins with integrity.