How to Correct an Entry in a GxP Record
Fix a mistake so that both the error and the correction remain visible.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Correcting a record is the most scrutinised routine act in documentation practice, because a correction done badly is indistinguishable from concealment. The principle is simple and absolute: the original entry stays readable. What separates an ordinary correction from a data integrity finding is not the mistake — it is whether anyone can still see what was there before.
- 1
Strike through once, leaving the original readable
A single line through the entry. Never obliterate, never overwrite, never use correction fluid, and never remove or replace a page. The whole point is that a reader can see both what was written and what replaced it.
- 2
Write the correct value nearby
Enter the correction adjacent to the original, clearly enough that the relationship between the two is unambiguous. A correction squeezed in so that it could be read as applying to a different field creates a new problem.
- 3
Initial and date the correction
The correction identifies who made it and when, which may be different from who made the original entry and certainly from when. Without those, the correction is an anonymous alteration of a record.
- 4
State the reason where the correction is not self-evident
A transposed digit needs no explanation. A changed result, a changed time, or a change made long after the fact does. The reason is what distinguishes a correction from an adjustment, and its absence invites the less charitable reading.
- 5
Apply the same discipline to electronic records
In a system, the audit trail is the mechanism: the original value, the new value, who, when and why, all retained. A system that permits a value to be changed without capturing the previous one is not fit for the purpose, whatever its other qualities.
- 6
Escalate a correction that changes a decision
Where a correction alters a result, a disposition or a conclusion, it is not a documentation matter. Route it through deviation or investigation so that whatever was decided on the wrong value gets revisited.
- !Correction fluid, overwriting, or an obliterated entry, which is indistinguishable from concealment.
- !A page replaced rather than corrected, destroying the original record entirely.
- !No reason recorded on a correction that changed a result or a time.
- !A correction that changes a decision handled as documentation rather than escalated as a deviation.
How to Correct an Entry in a GxP Record: frequently asked questions
Common questions on correct an entry in a gxp record.
Does every correction need a reason?
Not every one. A transposed digit corrected immediately by the person who wrote it is self-evident. A changed result, a changed time, or a correction made well after the event does need one, because without it the correction is ambiguous and ambiguity in a corrected record is read unfavourably.
What if a whole page is wrong?
Correct or void it visibly — strike it through, mark it void, sign and date, and record why — and keep it in the record. Replacing it removes the original, which is the one outcome the entire convention exists to prevent, regardless of how much cleaner the result looks.
How does this work in an electronic system?
Through the audit trail, which must retain the previous value alongside the new one with the person, timestamp and reason. The principle is identical to paper — the original stays visible — and a system that overwrites without capturing what was there is not fit for keeping regulated records.