GDP-良好的文件记录规范

GoodDocumentationPractices(GDP)良好的文件规范Definitionof

WhatisthedefinitionofGoodDocumentationPractices(GDP)?—Concise,Legible,AccurateandTraceablerecords

简明清楚准确可追溯

ThissimplestatementencompassesalltherequirementsofGDPSimpleStatement,HardTask?

Now—weknowthedefinition,butdoweunderstandit?Concise:Thedocumentmusttelltheentirestoryandbeunderstoodbyinternal/externalcustomersLegible:Thedocumentmustbereadablebyinternal/externalcustomers.Accurate:Thedocumentmustbeerrorfree.Traceable:Eachaspectofthedocumentmustbetraceable,suchas,whorecordedit,whereandwhy.HowDoWeMakeTheTaskEasy?

Let’sexaminewhatitmeanstobeconcise.—Areourdocumentsstandardized?—Arethedocumentseasyforalltouse?—Dowehavecertaindocumentsthatconsistentlyhaveerrors?—Doourdocumentstellacompletestory:thebeginning,themiddleandtheendtoeveryone?Oncethesequestionsareansweredandresolvedyoucanbeginanewunderstandingof“concise”.HowDoWeMakeTheskEasy?

Let’sexaminewhatlegiblemeans.—Init’smostsimpleform,legiblemeans:

Caneveryonereadwhatiswritten?Nomatterwho,whereorwhat,canthewrittenorprinteddatabereadbyeveryone?HowDoWeMakeTheTaskEasy?

Let’sexaminewhatitmeanstobeaccurate.—Datashallberecordedassoonaspossibleandshallnotbefalsified.Simple?Notreally.Anyonenowhasroomtodetermineforthemselves,whenandhow.Aprocessmustbeformulatedtocatchanyerrors.HowDoWeMakeTheTaskEasy?

Let’sexaminewhattraceabilitymeans.—Caneveryoneunderstandwhorecordedthedata,whyitwasrecorded,whatwasrecordedandwhenitwasrecorded.Iseveryonesigningforwhattheyrecorded?DowehaveaSOPthatrequirestherecord?Doweunderstandwhatitiswearerecording?Canwedeterminewhenitwasrecorded?—StandardizedDocumentationisKEY!!!!WhyShouldIDoThis?

Documentsareobjectiveevidencethatactionsortaskshavebeenperformed.RegulatoryAgenciesdonothaveCodeofFederalRegulations(CFR)requirementssayingtodothis.Why?BecauseGDPisanexpectedpractice!!!!!!!WhyShouldIDoThis?

Yourdocumentscanbesubpoenaedintocourt!Andanyonewhoworkedwiththatdocumentcanalsobesubpoenaedintocourtregardingthedocument!WhichRecords?

QualitySystemRecordsmustalwaysbereviewedforGDP.WhatareQualitySystemRecords?

GoodexamplesofQualitySystemRecordsare:

PurchaseOrdersManagementReviewsContractsTrainingRecordsDeviceMasterRecordsDeviceHistoryFilesWhatamIresponsiblefor?

Youareresponsibleforyoursignature:—WrittenSignatureWhatamIresponsiblefor?

Youareresponsibleforyoursignature:—ElectronicSignature—Itshallneverbetransmittedordisclosedtoanyoneelse—Youshouldneverusesomeoneelse’selectronicsignatureWhatamIresponsiblefor?

Youareresponsibleforallrecordedinformationbeforeyou……

WHAT?????WHY????Yes,youshouldbereviewingalldatabeforeyoutobesurenoonehasmadeanymistakes.WhatdoIdoiffindaMistake?

Allerrorsshouldbecorrectedbythepersonwhocreatedthem.Or,ifthatpersonisnotavailable,theerrorcanbecorrectedbytheirmanagerOr,ifthatpersonisnotavailable,theerrorcanbecorrectedbythenexthighestmemberofmanagement.Andsoonandsoon……etc.HowAreMistakesCorrected?

Foursimplesteps:—Drawasinglelinethroughtheerror—Makethecorrectionnexttotheerror—SignandDatetheCorrection—WriteanexplanationfortheerrorWhatdoIdoifIneedmorespace?

Whattodoifyoudon’thaveenoughspaceforthecorrection,explanationand/orsignatureanddate.Simpleenough:Drawanasterisk(*)nexttotheerror.Placetheasterisk/(*)onthesamepagewherethereisroomtowrite.Nowputyourinformationthere.IsThatAllINeedToKnow?

WellthiswoulddependonyourStandardOperatingProcedures(SOP).Likelyno,thereshouldbemore.DoyouhavewrittenSOP’s?Ok,whenindoubtwhatdoIdo?

Ask,Ask,Ask—Ican