What is 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–>was performed Recorded at the time work
O - Original–>First capture of data (raw data, not copied)
A - Accurate–>observation Error-free, truthful, reflects actual
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.
MBH/PS