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Old 16th May 2017, 08:30 AM
Ninja's Avatar

Total Posts: 972
Re: Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

In Reply to Parent Post by ehrbs27 View Post

In the '4.2.5 Control of records', the standard requires the document procedures to define the controls needed for the integrity.
You can find them.
Everyone who needs to access them can find them.
They are not lost.
They are not changed.
I can trust that when I read it, I am reading the correct version.
When I read it, I can see all of it.
No one changed it without authorization.
It can still be trusted after your computer network crashes.
Bob on the shop floor didn't mark up changes on it when he was angry.

Whole. Trustworthy. Reliable. Complete.

Data Integrity: Data integrity is the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. {Wiki definition...and right on the money}

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