* Contemporaneous with the event they describe<ref name=EUGMP4 />{{Rp|___location=¶4.8}}<ref name="FDAGCP">[https://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135196.htm{{HHS UScontent|source={{Cite FDA.web "|date=April 1999 |title=Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS"April|url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials 1999]|url-status=live –|archive-url=https://web.archive.org/web/20200924221420/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials |archive-date=24 September 2020 |access-date=15 October 2022 |website=U.S. AccessedFood 4and FebruaryDrug 2010Administration}}}}</ref><ref name=WHO4 /><ref name=ICH7 />
* Not handwritten (except for handwritten entries thereon)<ref name=EUGMP4 />{{Rp|___location=¶4.6}}
* When electronically produced, the documentation must be checked for accuracy<ref name=EUGMP4 />{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}
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=== Copies of documents ===
* Clear, legible<ref name=EUGMP4 />{{Page needed|date=October 2022|reason=Cannot find this in the document; needs additional reviewer to confirm.}}<ref name="WHO4">[http{{Cite techreport |url=https://whqlibdocapps.who.int/trsiris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf |chapter-url=https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf#page=106 |last=WHO. Expert TRSCommittee 961 "Good Manufacturingon PracticesSpecifications for Pharmaceutical Products:Preparations Main|title=Fourty-fifth Principles"Report |number=961 |institution=[[World Health Organization]] |date=2011 (|series=WHO Technical Report Series |chapter=Annex 3,. SectionWHO good manufacturing practices for pharmaceutical products: main principles |url-status=live |archive-url=https://web.archive.org/web/20220901051256/https://apps.who.int/iris/bitstream/handle/10665/44079/WHO_TRS_961_eng.pdf |archive-date=15)] October 2022 }}</ref><ref name=MHLW169>[http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Japan MHLW. Ministerial Ordinance No. 169, 2004, "Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents" (Chapter 2, Section 2, Article 8, Paragraphs 2 and 4)] {{Webarchive|url=https://web.archive.org/web/20110722105510/http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf |date=22 July 2011 }} – Accessed 7 January 2011</ref>
* Errors are not introduced<ref name=EUGMP4 />{{Rp|___location=¶4.2}}<ref name=WHO4 /><ref name=FDAJ />
