Data integrity in pharma industry refers to the completeness, consistency, and accuracy of data. Where complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) throughout the lifecycle of the product.
Significant Data Integrity Violations:
- The site failed to thoroughly review unexplained discrepancies.
- The site generated false and misleading data.
- The site conducted preliminary testing prior to testing on the official system (e.g., Trial injection).
Many things can harm your data. Here are some:
- Human Error: When people make mistakes.
- Hackers: Bad people wanting to steal or damage data.
- Malware: Nasty software that can mess up data.
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