GDP-良好的文件記錄規(guī)范解讀課件

GoodDocumentationPractices(GDP)良好的文件規(guī)范

GoodDocumentationPracticesDefinitionof

WhatisthedefinitionofGoodDocumentationPractices(GDP)?—Concise,Legible,AccurateandTraceablerecords

簡(jiǎn)明清楚準(zhǔn)確可追溯

ThissimplestatementencompassesalltherequirementsofGDPDefinitionof

WhatisthSimpleStatement,HardTask?

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

NHowDoWeMakeTheTaskEasy?

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

HowDoWeMakeTheskEasy?

Let’sexaminewhatlegiblemeans.—Init’smostsimpleform,legiblemeans:

Caneveryonereadwhatiswritten?Nomatterwho,whereorwhat,canthewrittenorprinteddatabereadbyeveryone?HowDoWeMakeTheskEasy?

LeHowDoWeMakeTheTaskEasy?

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

HowDoWeMakeTheTaskEasy?

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

WhyShouldIDoThis?

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

DocumentWhyShouldIDoThis?

Yourdocumentscanbesubpoenaedintocourt!Andanyonewhoworkedwiththatdocumentcanalsobesubpoenaedintocourtregardingthedocument!WhyShouldIDoThis?

YourdocWhichRecords?

QualitySystemRecordsmustalwaysbereviewedforGDP.WhichRecords?

QualitySystemWhatareQualitySystemRecords?

GoodexamplesofQualitySystemRecordsare:

PurchaseOrdersManagementReviewsContractsTrainingRecordsDeviceMasterRecordsDeviceHistoryFilesWhatareQualitySystemRecordWhatamIresponsiblefor?

Youareresponsibleforyoursignature:—WrittenSignatureWhatamIresponsiblefor?

YoWhatamIresponsiblefor?

Youareresponsibleforyoursignature:—ElectronicSignature—Itshallneverbetransmittedordisclosedtoanyoneelse—Youshouldneverusesomeoneelse’selectronicsignatureWhatamIresponsiblefor?

YouWhatamIresponsiblefor?

Youareresponsibleforallrecordedinformationbeforeyou……

WHAT?????WHY????Yes,youshouldbereviewingalldatabeforeyoutobesurenoonehasmadeanymistakes.WhatamIresponsiblefor?

YouWhatdoIdoiffindaMistake?

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

Foursimplesteps:—Drawasinglelinethroughtheerror—Makethecorrectionnexttotheerror—SignandDatetheCorrection—WriteanexplanationfortheerrorHowAreMistakesCorrected?

FoWhatdoIdoifIneedmorespace?

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

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

WeOk,whenindoubtwhatdoIdo?

Ask,Ask,Ask—Icannotstressthisenough.AskyourManager,QualityoraCompanyAuditorYouarelegallyresponsiblefordocumentsyousign!!!Remember,ifyouletanGDPerrorgo,itwillbeworselater.Ok,whenindoubtwhatdoIdo

Q&A

Thankyouforyourtime!Thankyouforyourtime!

GoodDocumentationPractices(GDP)良好的文件規(guī)范

GoodDocumentationPracticesDefinitionof

WhatisthedefinitionofGoodDocumentationPractices(GDP)?—Concise,Legible,AccurateandTraceablerecords

簡(jiǎn)明清楚準(zhǔn)確可追溯

ThissimplestatementencompassesalltherequirementsofGDPDefinitionof

WhatisthSimpleStatement,HardTask?

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

NHowDoWeMakeTheTaskEasy?

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

HowDoWeMakeTheskEasy?

Let’sexaminewhatlegiblemeans.—Init’smostsimpleform,legiblemeans:

Caneveryonereadwhatiswritten?Nomatterwho,whereorwhat,canthewrittenorprinteddatabereadbyeveryone?HowDoWeMakeTheskEasy?

LeHowDoWeMakeTheTaskEasy?

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

HowDoWeMakeTheTaskEasy?

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

WhyShouldIDoThis?

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

DocumentWhyShouldIDoThis?

Yourdocumentscanbesubpoenaedintocourt!Andanyonewhoworkedwiththatdocumentcanalsobesubpoenaedintocourtregardingthedocument!WhyShouldIDoThis?

YourdocWhichRecords?

QualitySystemRecordsmustalwaysbereviewedforGDP.WhichRecords?

QualitySystemWhatareQualitySystemRecords?

GoodexamplesofQualitySystemRecordsare:

PurchaseOrdersManagementReviewsContractsTrainingRecordsDeviceMasterRecordsDeviceHistoryFilesWhatareQualitySystemRecordWhatamIresponsiblefor?

Youareresponsibleforyoursignature:—WrittenSignatureWhatamIresponsiblefor?

YoWhatamIresponsiblefor?

Youareresponsibleforyoursignature:—ElectronicSignature—Itshallneverbetransmittedordisclosedtoanyoneelse—Youshouldneverusesomeoneelse’selectronicsignatureWhatamIresponsiblefor?

YouWhatamIresponsiblefor?

Youareresponsibleforallrecordedinformationbeforeyou……

WHAT?????WHY????Yes,youshouldbereviewingalldatabeforeyoutobesurenoonehasmadeanymistakes.WhatamIresponsiblefor?

YouWhatdoIdoiffindaMistake?

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

Foursimplesteps:—Drawasingle