ALCOA+ principles

 

ALCOA+ principles for Data Integrity, widely used in pharma, biotech, medical devices, and regulated industries (as per FDA, EMA, WHO, and EU GMP expectations):

🔹 ALCOA Principles

These are the five core pillars of data integrity:

  1. Attributable
    • Every piece of data must clearly show who performed an action and when.
    • Example: A laboratory entry should be signed/initiated and dated by the analyst, not left anonymous.
    • Why? Ensures accountability.
  2. Legible
    • Data must be readable and permanent. Handwritten records should not fade; electronic records should be stored in durable formats.
    • Example: Avoid pencil entries, ensure electronic data is not corrupted.
    • Why? If data can’t be read, it can’t be trusted.
  3. Contemporaneous
    • Record data at the time the activity is performed, not later.
    • Example: Recording batch parameters during manufacturing in real time, not hours later.
    • Why? Prevents manipulation and memory-based errors.
  4. Original
    • Keep the first capture of data or a certified true copy.
    • Example: Original chromatogram printouts or secured electronic raw data files, not transcribed numbers.
    • Why? Original records are most reliable.
  5. Accurate
    • Data must be error-free, truthful, and precise.
    • Example: Ensure instruments are calibrated, no false results entered to “fit expectations.”
    • Why? Decisions based on wrong data can risk patient safety.

🔹 The “+” in ALCOA+

These are extended principles that make data integrity more robust:

  1. Complete
    • All data (including repeats, out-of-spec results, failed runs) must be included.
    • Example: Don’t hide or delete failed test results.
    • Why? Partial data gives a false picture.
  2. Consistent
    • Data should be in chronological order with time stamps, no unexplained gaps.
    • Example: Batch records should flow step by step with no missing entries.
    • Why? Ensures transparency.
  3. Enduring
    • Data must be stored in a durable medium (paper archives, validated electronic systems).
    • Example: Using controlled logbooks or validated LIMS, not sticky notes.
    • Why? Data must remain intact for years.
  4. Available
    • Data should be easily retrievable throughout its retention period.
    • Example: Regulatory inspections should be able to access historical records immediately.
    • Why? Availability supports trust and compliance.

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