Good documentation practice: Difference between revisions

Revision as of 01:21, 2 December 2022

Revision as of 17:19, 7 March 2023

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=== Document maintenance ===

* Regularly reviewed and kept current<ref name=EUGMP4 />{{Rp|___location=¶4.5}}<ref name=EC94 />

* Retained and available for appropriate duration<ref name=EUGMP4 />{{Rp|___location=¶4.12}}<ref name=EC94 /><ref name=EUGMP6 /><ref name=FDAJ>[http{{Cite web|title=CFR - Code of Federal Regulations Title 21|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=&#61;211&showFR=&#61;1&subpartNode=&#61;21:4.0.1.1.11.10 21CFR211 Subpart J]|access-date=2023-03-07|website=www.accessdata.fda.gov}}</ref><ref name=MHLW169 />

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

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

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* Controls exist to prevent the inadvertent use of superseded documents<ref name=WHO4 /><ref name=MHLW169 />

* Electronic versions can only be modified by authorized personnel<ref name=FDAGCP />

* A history ([[audit trail]]) must be maintained of changes and deletions to electronic versions<ref name=FDAGCP /><ref name=ICH7>[http{{Cite web|title=ICH Official web site : ICH|url=https://www.ich.org/cache/compo/363index.html|access-272date=2023-103-07|website=www.html#Q7A ICHich. "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" (Section 6)]org}}</ref><ref name=EC94 />

* Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)