ALCOA+ Principles
The foundational framework for ensuring data integrity in regulated laboratory environments, expanded to address modern electronic record requirements.
What is ALCOA+?
- ALCOA+
- ALCOA+ is an acronym representing the fundamental principles of data integrity required by regulatory agencies like the FDA, WHO, and EMA. Originally developed as ALCOA, the framework was expanded to ALCOA+ to address additional aspects critical for electronic records and modern laboratory operations.
The Original ALCOA Principles
Attributable
Data must clearly identify who performed an action and when. For electronic systems, this includes secure user identification, electronic signatures, and audit trails that capture the user's identity.
Legible
Data must be readable and permanent throughout its required retention period. Electronic records must be accessible and displayable in human-readable format.
Contemporaneous
Data must be recorded at the time the activity is performed. No backdating or pre-dating of entries is acceptable.
Original
The first recording of data (or a true copy) must be preserved. Original data is the source document or first capture of information.
Accurate
Data must be free from errors, truthful, and reflect actual observations. Changes must be documented with reasons.
The "+" Elements
Complete
All data must be present, including any repeat or reanalysis results. No selective reporting or cherry-picking of results.
Consistent
Data elements should follow expected sequences and relationships. Timestamps should be chronologically logical.
Enduring
Records must be durable and stored in a manner that ensures their preservation for the required retention period.
Available
Data must be accessible for review throughout its lifecycle. Electronic data must be retrievable in a timely manner.
LIMS and ALCOA+ Compliance
A properly configured LIMS automatically supports ALCOA+ requirements through secure user authentication, comprehensive audit trails, automatic timestamping, data versioning, and secure archival capabilities. This makes electronic systems essential for modern data integrity compliance.