TOPIC: Data Integrity Principles (ALCOA+)
Real-life and Laboratory Examples | Paper &
Electronic
What is Data Integrity?
• Definition: Data integrity means data is complete, consistent,
and accurate throughout its lifecycle.
• Applicable To:
Paper records
Electronic records
• Foundation: ALCOA & ALCOA+ principles
ALCOA Principles
A - Attributable
L - Legible
C - Contemporaneous
O - Original
A - Accurate
ALCOA+ Extension
Complete
Consistent
Enduring
Available
Attributable
Definition: Who did it and
when?
Lab Examples:
o Analyst initials on logbook
o Analyst ID in electronic
system
Daily Life Examples:
o Signed courier receipt
o User ID on ATM slip
Paper: Signature or initials
Electronic: System-generated
user ID & audit trail
Legible
Definition: Clear and readable
data
Lab Examples:
o Neat HPLC data printout
o Clear handwriting in
notebooks
Daily Life Examples:
o Legible prescription
o Neatly filled application form
Paper: Blue/black ink, no
overwriting
Electronic: Readable fonts &
layout
Contemporaneous
Definition: Data recorded in
real-time
Lab Examples:
o Weight recorded immediately
o Cleaning logs filled on spot
Daily Life Examples:
o Punch-in at work
o Diary entry
Paper: Real-time
signatures/date
Electronic: Auto-timestamped
logs
Original
Definition: First capture or true
copy
Lab Examples:
o First pH reading entry
o Primary chromatogram
Daily Life Examples:
o Original degree certificate
o Original restaurant bill
Paper: Wet-ink signature
Electronic: System-generated
file with metadata
Accurate
Definition: Correct and error-
free
Lab Examples:
o Verified test calculations
o Correct ID of sample
Daily Life Examples:
o Correct IFSC code in form
o Accurate details in tax return
Paper: Verified calculations
Complete
Definition: No missing data
Lab Examples:
o Failed HPLC runs recorded
o Complete calibration records
Daily Life Examples:
o All bills for tax filing
o Complete medical history
Paper: Bound logs, no missing
pages
Electronic: Full audit trail, backup
Consistent
• Definition: Chronological and uniform
• Lab Examples:
o Test sequence correct
o Consistent format for IDs
• Daily Life Examples:
o Ordered utility bills
o Sequential diary entries
• Paper: Same format, date order
• Electronic: Auto-sequenced entries
Enduring
• Definition: Long-lasting and safe
• Lab Examples:
o Archived COAs for 5 years
o Bound logbooks
• Daily Life Examples:
o Property documents
o Preserved birth certificate
• Paper: Laminated, stored files
• Electronic: RAID backup, PDF/A archive
Available
• Definition: Easily accessible when needed
• Lab Examples:
Access to archived stability data
Old SOP retrieval
• Daily Life Examples:
Access to old email bills
Download vaccination proof
• Paper: Indexed files
• Electronic: Searchable databases, LIMS
ms
Accurate
Definition: Correct and error-free
Lab Examples:
o Verified test calculations
o Correct ID of sample
Daily Life Examples:
o Correct IFSC code in form
o Accurate details in tax return
Paper: Verified calculations
Electronic: Validated formulas/systems
