European Union GMP Annex 11

Brief post to highlight this; I'm sure everyone has looked at it. A very detailed regulation now, especially compared with the original Annex 11.

The European Compliance Academy provided an analysis of the new text (and the related Chapter 4 update). And while it is generally useful in discussing the changes and the alignment / differences with Part 11, be sure tio read the actual text of Annex 11. The ECA analysis does have flaws that might lead to an incorrect interpretation.

For example, in their detailed analysis, the reviewer states....
"Furthermore there is now the need for requirements traceability throughout the life cycle, for the first time in a regulation a traceability matrix is required."

This is completely missing the point and mis-stating the regulation. What the regulation states is...
"4.4... User requirements should be traceable throughout the life-cycle."
There is no mention of a traceability matrix! A traceability matrix is just one way to document traceability. Another way to embed traceability via naming convention.