Data Integrity (ALCOA & ALCOA+)

Data Integrity means: Data must be trustworthy, reliable, and accurate throughout its entire lifecycle.

Why Data Integrity is Critical in Pharma

  • Ensures patient safety
  • Supports product quality and efficacy
  • Mandatory for GMP, GLP, GCP compliance
  • Major focus area during regulatory inspections

ALCOA Principles

1. Attributable

Data must clearly show who performed the activity and when.

Example: Analyst name, signature, date, and time on test records.

2. Legible

Data must be readable and understandable for the entire retention period.

Example: Clear handwriting, readable printouts, clear electronic display.

3. Contemporaneous

Data must be recorded at the time the activity is performed.

Example: Recording test results immediately after analysis, not later.

4. Original

Data must be the first recorded source or a verified true copy.

Example: Raw instrument printouts, original lab notebook entries.

5. Accurate

Data must be correct, error-free, and verified.

Example: Correct calculations, calibrated instruments, reviewed results.

ALCOA+ Additional Principles

6. Complete

All data including repeats, failures, and deviations must be recorded.

Example: Recording failed test results, not only passing ones.

7. Consistent

Data must follow logical sequence and uniform format.

Example: Sequential dates, batch numbers, and record flow.

8. Enduring

Data must be preserved on durable media for the required retention period.

Example: Secure servers, controlled paper archives.

9. Available

Data must be easily retrievable for review and inspection.

Example: Organized document management and backup systems.

Common Data Integrity Violations

  • Backdating or pre-dating records
  • Deleting or overwriting raw data
  • Using shared user IDs
  • Not recording failed or repeated tests
  • Uncontrolled corrections

Correction Rules (Good Practice)

  • Never erase or overwrite data
  • Single line strike-through for paper correction
  • Correction must be signed, dated, and justified
  • Original data must remain visible

Interview Key Line (Remember This)

"If data integrity is compromised, product quality and patient safety cannot be assured."