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Topic Life Sciences
Life Sciences

What is ALCOA in Pharma? A Simple Guide to Data Integrity

💬 In plain words: Data integrity means a record is complete, accurate, and completely trustworthy from the moment it is created until the end of its required lifecycle. If the data cannot be trusted, the final quality decisions about a medicine cannot be trusted either. 📌 Example: If you read a machine temperature at 10:05 AM, you must write down that exact reading at 10:05 AM. Do not wait until 3:00 PM and try to guess what the screen said hours ago. 🎬 Real-Life Example: Correcting a Wrong Entry An operator accidentally writes down "45.0 kg" but immediately realizes the actual scale value was "4.50 kg." The Old/Bad Way: Erasing the first value, using white-out, or scribbling over it so nobody can see the original mistake. Why it's bad: The original record is destroyed. An auditor or reviewer can no longer see what changed or why. The New/Good Way: Correct the entry using your company's officia...