Good documentation practice: Difference between revisions

Revision as of 15:04, 8 March 2020

Revision as of 16:12, 12 June 2020

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* Regularly reviewed and kept current<ref name=EUGMP4 /><ref name=EC94 />

* Retained and available for appropriate duration<ref name=EUGMP4 /><ref name=EC94 /><ref name=EUGMP6 /><ref name=FDAJ>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.10 21CFR211 Subpart J]</ref><ref name=MHLW169 />

* Electronic [[document management system]]s are [[Validation (drug manufacture)|validated]]<ref name=EC94 />

* Electronic records are backed up<ref name=EUGMP4 /><ref name=EC94 />