Data Integrity Principles
ALCOA+++
CONTENTS
1. Attributable 2. Legible
3. Contemporaneous 4. Original
5. Accurate 6. Complete
7. Consistent 8. Enduring
9. Available 10. Traceable
01
ATTRIBUTABL
ATTRIBUTABLE
1 Definition
• Data must be linked to the person or system that created or changed it.
2 Example
• Paper: A lab notebook entry is signed and dated by the technician.
technician.
• Electronic: System log’s username and timestamp of the person who
person who entered the data.
02
LEGIBL
LEGIBLE
Definition Example
• Paper: Entries must be neat and use permanent ink
• Data must be clear and readable throughout its life.
so they don’t fade.
• Electronic: Data is displayed in a clear, readable
font and format on the screen.
03
CONTEMPORANEOU
CONTEMPORANEOUS
1 Definition
• Data must be recorded at the time of the activity.
2 Example
• Paper: Record data immediately on a log sheet as they are t
• Electronic: Data is automatically logged in real-time by the
system as the activity occurs.
04
ORIGINA
ORIGINAL
Definition Example
• Data must be the first recorded instance, not a copy. • Paper: The initial handwritten entry on the lab she
• Electronic: The first entry in the database without
alterations.
05
ACCURAT
ACCURATE
Definition
• Data must be correct and free from errors.
Example
• Paper: If a pH reading is 7.4, it should be entered as 7.4, not estimated or rounded off.
• Electronic: Data entries reflect true values, with changes tracked and justified.
06
COMPLET
COMPLETE
Definition
• All data and necessary information must be included.
Example
• Paper: Every required field on a form is filled out, including any
re-tests.
• Electronic: All fields in the data entry form are completed, and
all necessary metadata is included.
07
CONSISTEN
CONSISTENT
Definition
• Data must be recorded in a chronological and logical order.
Example
• Paper: Use the same date format and units throughout all records.
• Electronic: Data is entered in a consistent format and timestamps
follow a standard sequence.
08
ENDURIN
ENDURING
Definition Example
• Data must remain intact and accessible for its • Paper: Records should be stored in a secure, long-
retention period. lasting format.
• Electronic: Data is backed up regularly and stored
a secure, long-term storage system.
09
AVAILABL
AVAILABLE
1 Definition
• Data should be accessible for review or audits whenever
needed.
2 Example
• Paper: Records are organized and stored in a way that allow
easy retrieval.
• Electronic: Data can be accessed quickly from a digital
database.
10
TRACEABL
TRACEABLE
Definition Example
• Data must be able to be traced back to its source. • Paper: Each entry includes an identifier for the
person and the time of recording.
• Electronic: Audit trails show who accessed or
modified the data and when.
THANK YOU