Health Canada · Life Science & Pharma: GxP - CSV & Data Integrity
Annex 11 to the good manufacturing practices guide: Computerized Systems (GUI-0050)
Final CSV & Data Integrity · Annex Last verified: not yet · Source last checked 3 Nov 2026
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- Health Canada
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- Annex
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Canada's guidance on computerised systems, adopted directly from Annex 11 of the PIC/S GMP Guide, with Canadian terms.
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Lifecycle
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In plain English
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.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
Health Canada published GUI-0050 on 10 August 2021. It is adopted directly from Annex 11 of the PIC/S GMP Guide (PE-009-15), with some PIC/S terms replaced by Canadian ones. So it closely mirrors EU Annex 11 (2011). Health Canada says the document is not part of the Food and Drugs Act.
Who and what it applies to
Establishments under Canadian drug GMP. This site treats it as link-only for now.
What it contains
- Structure
- Follows Annex 11, covering principles, general, project phase and operational phase.
Key points
- It is a direct adoption of PIC/S Annex 11.
- If the EU and PIC/S revise Annex 11, watch for a change here.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- If you already meet Annex 11, expect close alignment, and check the Canadian terms.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 10 Aug 2021 | Published | Final | Source for Published |
Related
How other documents connect to this one. Links explained
- Implements PIC/S GMP Guide PE 009· Compare with PIC/S GMP Guide PE 009 Unverified link
Official source
The official text always prevails over anything on this site.
Summary in our own words. See the official text from Health Canada.
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