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)
A – Accurate → Error-free, truthful, reflects actual observation
The “+” 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
Why ALCOA+ Matters
- Prevents data manipulation or falsification
- Builds trust in lab and manufacturing records
- Ensures compliance with GLP/GMP/cGMP
- Protects patients → because bad data = unsafe medicines
ALCOA+ is not just a checklist—it’s the backbone of data integrity in GLP and GMP.