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13485 Base Templates#78

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yujanshrestha wants to merge 29 commits intomaininnolitics/rdm:mainfrom 13485_checklistinnolitics/rdm:13485_checklistCopy head branch name to clipboard

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Commits on Dec 31, 2020

• Begin adding 13485 checklist.

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  15736d7

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• Add remaining 13485 checklist items.

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• Add 13485 prefix.

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Commits on Jan 13, 2021

• Add initial quality manual compliant to IMDRF /SaMD WG/N23 recommendations.

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• Add SOP creation SOP.

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• Add SOP change SOP.

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• Add SOP removal SOP.

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• Add new record template template.

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• Add SOP review SOP.

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Commits on Jan 15, 2021

• Add new vendor SOP and record template.

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• Add CAPA SOP and CAPA record template.

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• Move approvals up to the top.

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• Add skeleton sections from IMDRF.N23 to the quality manual.

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• Restructure into separate organization and product quality management systems.

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Commits on Jan 20, 2021

• Add tools validation process

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Commits on Jan 28, 2021

• Restructure init templates.

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• Add 21.CFR.820 references.

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• Add 21.CFR.820 references and training record.

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• Add sections to quality manual per 21.CFR.820.

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• Add 21.CFR.820 checklist.

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• Add risk management process.

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• Change wording of problem report qualification.

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• Reformat whitespace.

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• Remove IMDRF version of quality manual.

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• Add Audit SOPs and Record templates

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Commits on Feb 2, 2021

• Add training SOP.

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Commits on Mar 9, 2021

• Add templates.

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• Add verification and validation plan.

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• Add risk management process assets.

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