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| 01902nam 2200385zi 4500 |
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| 001 | 9.890213 |
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| 003 | CaOODSP |
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| 005 | 20221107172528 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 200806t20212021onc ob f00| 0 eng d |
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| 020 | |a9780660357454 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH139-18/2021E-PDF |
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| 245 | 00|aAnnex 11 to the good manufacturing practices guide : |bcomputerized systems. |
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| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2021. |
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| 264 | 4|c©2021 |
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| 300 | |a1 online resource (16 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aIssued also in French under title: Annexe 11 aux lignes directrices surles bonnes pratiques de fabrication : systèmes informatisés. |
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| 500 | |aIssued also in HTML format. |
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| 500 | |a"GUI-0050." |
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| 500 | |a"August 10, 2021." |
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| 504 | |aIncludes bibliographical references (pages 15-16). |
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| 520 | |a"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. |
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| 650 | 0|aMedical instruments and apparatus|zCanada. |
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| 650 | 0|aComputer systems|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tAnnexe 11 aux lignes directrices sur les bonnes pratiques de fabrication : |w(CaOODSP)9.890212 |
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| 856 | 40|qPDF|s1.21 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H139-18-2021-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-11-guide-computerized-systems-gui-0050.html |
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