cGMP Data Integrity new Requirements adopted by the FDA and WHO

Data integrity reinforcements have become a highlighted topic. We want to switchgear in this post around data integrity around multiple organizations. If you wish to book a demo with us, please feel free to reach out to me. Here is a link: R.A. to show you how we can accelerate GMP training within your organization. 

Data Integrity is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. To consider records to be reliable and trustworthy, they must comply with the principles of: 

Principles

  1. Attributable – who made the record or created the data and when 
  2. Legible – write the data so it is easily read and understood for the lifetime of the record. That is to avoid referring to the originator for clarification. Keep the recorded data for five-ten or Twenty Years’ time, perhaps after the originator is no longer available.
  3. Contemporaneous – the record data information must be made at the time the activity was performed.
  4. Original – earliest records of the data, could be written observation, print out or electronic file or a certified copy. The information must not be written on a Post-It, piece of scrap paper, etc., and then transcribe and saved in a temporary location. 
  5. Accurate – no errors or editing without documenting changes.

Both the FDA and the WHO are using those principles, since they have been updated. These principles focus on complete, consistent, enduring, and available data. 

  1. Complete – make all the data available. Do not delete any evidence; it must be available in an audit trail.
  2. Consistent – record the data chronologically with the date and time evident in the audit trail.
  3. Enduring – data is accessible for an extended period of time.

Available – data is accessible over the lifetime of the product.

Remember… Data Integrity applies to everyone in the organization whether you’re generating or working with data electronically or manually on paper.

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