Data Integrity

Why is Data Integrity Important?

“Data Integrity is considered as the first and foremost requirement in a pharmaceutical quality system to ensure that the medicines are of the required quality”

What is Data Integrity

Data Integrity is defined as the “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.”

Data Integrity- Core Requirements

  •  An environment for controlled access to Apps
  •  Automatic storage of data & meta data to serverwithout user intervention
  •  Users should be able continue to update data
  •  Modified data should be moved to server automatically
  •  Audit trail of all activities at server and client side
  •  Review & approval based on server data (true copy)
  •  Disposition based on– Single source of truth

GMP 8 Data Generation & Recording

  •  How and where is original data created?
  •  Normally created locally, With a true copy on the server (controlled area)
  •  How do you ensure that the data is complete, accurate and traceable to meet ALCOA?
  •  Automation ensures that (raw, meta, human readable) are all moved to server
  •  Is it possible to recreate, amend or delete original data and metadata?
  •  Automation to validate amendments and NO possibility to delete or obscure data
  •  How data is transferred to other locations or systems for processing or storage
  •  Automation can help in transfer of data in a controlled manner for processing or storage. Any change due to processing needs to be handled by automation solution.

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