Health Canada GUI-0050 and its 1 linked instrument

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	Health Canada GUI-0050	PIC/S GMP Guide PE 009
Authority	Health Canada	PIC/S
Legal weight	Guidance & Q&A	GMP guide & annexes
Status	Final	In force
Last verified	Not yet	Not yet
Summary	Health Canada guidance on computerized systems, adopted directly from Annex 11 of the PIC/S GMP Guide (PE 009-15), with some terms replaced by Canadian ones. Link only.	The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.
Lifecycle	10 Aug 2021 Published	23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17
Source	Official text Summary in our own words. See the official text from Health Canada.	Official text Summary in our own words. See the official text from PIC/S.

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