GxP Record Correction Log
Correction log built on the principle that the original entry stays readable, with a permitted-versus-never table, per-correction reasons, an escalation assessment for corrections that changed a decision, and an electronic section treating the audit trail as the digital strike-through. Maps to WHO TRS 996 Annex 5 and PIC/S PI 041-1.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
Correcting a record is the most scrutinised routine act in documentation practice, because a correction done badly is indistinguishable from concealment. What separates an ordinary correction from a finding is whether anyone can still read what was there before, and why it changed. Whether a given correction also changed a decision — and therefore belongs in deviation handling rather than in this log — is your assessment.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
WHO TRS 996 Annex 5 sets the record-correction expectations — the original entry stays readable, the change is attributable, dated and explained — and PIC/S PI 041-1 carries the data-integrity treatment of amendments across GMP and GDP, paper and electronic. Neither defines when a correction stops being documentation and becomes a deviation in your quality system. That threshold is your determination, and the escalation assessment here is SPEQ practitioner synthesis intended to make you set it in advance.