Annex 11 to the good manufacturing practices guide : computerized systems.: H139-18/2021E-PDF

"This annex applies to all forms of computerized systems used as part of Good Manufacturing Practices (GMP) regulated activities. A computerized system is a set of software and hardware components which together fulfil certain functionalities"--page 5.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.890213&sl=0

Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Annex 11 to the good manufacturing practices guide : computerized systems.
Publication type Monograph
Language [English]
Other language editions [French]
Format Electronic
Electronic document
Note(s) Issued also in French under title: Annexe 11 aux lignes directrices surles bonnes pratiques de fabrication : systèmes informatisés.
Issued also in HTML format.
"GUI-0050."
"August 10, 2021."
Includes bibliographical references (pages 15-16).
Publishing information [Ottawa] : Health Canada = Santé Canada, 2021.
©2021
Description 1 online resource (16 pages)
ISBN 9780660357454
Catalogue number
  • H139-18/2021E-PDF
Departmental catalogue number 200161
Subject terms Medical instruments and apparatus -- Canada.
Computer systems -- Canada.
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