The following guidelines are applicable to corrections made to GxP activities at any time:
– Draw a single line through the error. [Do not obscure it, erase it or cover it up.] Then, place your initials and the current date somewhere near the line so it’s obvious to a reviewer that they are related.
– Enter the correct data entry near the crossed-out error so it’s obvious to a reviewer that they are related. Then place your initials and the current date somewhere near the correct entry so it’s obvious to a reviewer that they are related.
– Indicate the reason for change somewhere near the corrected entry.
You can use abbreviations but the abbreviation should be defined in a procedure or explained somewhere else near the correction, like a footnote or endnote.
– If the error occurs in a manufacturing process, it should be evaluated to determine whether it’s falls under the scope of your deviation procedures.
Remember, the whole purpose of making the correction is to ensure that the data is accurate, that you can tell who made the data entries and when they were made, and that a reviewer can understand the chain of events.
