How to Correct Raw Data

If you work for a pharmaceutical or medical device company, the first thing you learn is how to correct raw data.
When modifying raw data, the original data must be struck through with a single line so as not to obscure it, and the reason for the modification, the signature of the modifier, and the date of the modification must be noted.
In the past, two lines were used to cancel each other out, but since they can be difficult to see, a single line is now the norm.
So why is such a tedious process necessary?
If the correction is correct, why not just overwrite it?
In fact, this is because the correction may be a mistake.
This is because it is possible that the original data is actually correct due to a misunderstanding or assumption, even though the person who made the correction thought he or she had corrected the data correctly.
In the course of his work, the author conducts audits at many pharmaceutical and medical device companies.
At that time, the manufacturing and test records are audited.
Often, we see frequent corrections of errors in those records.
Correcting errors is not a problem.
However, the author’s question is: “Was it really a misstatement?” “If so, is this really all there is?” The author’s question is, “If it was a mistake, is this really all there is?
One would suspect that there is something wrong with the workers who make frequent misstatements.
Perhaps they are fidgety, unsuitable, or too busy.
Or perhaps education and training is inadequate and they do not understand the SOPs correctly.
In most cases, the quality assurance department also does not comment on shipment decisions.
If there are many errors, a CAPA should be drafted to thoroughly investigate the cause and reduce the number of errors as much as possible.
In addition, other data must also be re-verified for omissions of corrections. When the author was trained as an auditor, he recalls that he was taught that records must be scrutinized with attention to the corrections.
The author recalls that when he was trained as an auditor, he was taught that records must be scrutinized with attention to the corrections.

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