module 9 gclp good documentation practice

8/18/2019 Module 9 Gclp Good Documentation Practice

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GOOD DOCUMENTATIONPRACTICES IN CLINICAL

LABORATORY

KEMRI-Wellcome Trust Research

Programme


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What is Good DocumentationPactice!Document is information (meaningful data) and

its supporting medium, in form of paper, CD,Computer le, microlm, x!a" lm etc

Documents pro#ides information or e#idence or

ma" ser#e as an o$cial record.!ecord is a document stating results achie#ed

or pro#ide e#idence of acti#ities performed.Guidelines is a document that pro#ides

recommended practices and instructions.%olic" is a plan or adopted course or principle

of action intended to in&uence and determinethe decisions or actions of an organi'ation.


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Pu"ose o# La$oato%Documentation o pro#ide the basic guide for good document

practices with regard to creation, appro#al,re#iew, maintenance, correction or errors,#erication and archi#ing etc

nsures documented e#idence, traceabilit",pro#ide records and audit trails for in#estigation

nsures a#ailabilit" of data for #alidation,re#iew and statistical anal"sis.

Control of %rocess nsures all sta* +nows whatto do and when to do it.

o impro#e performance

!egulator" reuirements.


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What constitutes GoodDocumentation

Le&i$'e( e#er"one should be able to read whatis written regardless of who, where or what hasbeen written.

Concise( the document must pro#ide clear

information that is understood b" all customersTacea$'e( who recorded it, where and wh"

Contem"oaneous( the information should bedocumented at the correct time frame along

with &ow of e#entsEnduin&( Long lasting and durable

Accessi$'e( asil" a#ailable for re#iew.


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Documentation Pocess in theLa$oato%

Document creation and appro#alDocument use and data collection

Document maintenance and #erication

!ecord !e#iew!ecord 3odication and Correction

!ecord /rchi#ing

!ecord Destruction


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Common DocumentationEos3issing signature and dates at the time of

acti#it" performed.

he writeo#er

0onuniform date and signature entr"4riting a note that acti#it" was performed

on one da" and signed for on other da".

1lan+ spaces

5llegible writing oo man" corrections


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Pinci"'es o# Good DocumentationPactice

/ document bearing original signaturesshould ne#er be destro"ed.0e#er falsif" information0e#er "ou a 4hiteout and co#ero#ertapes

0e#er obliterate information or record0e#er o#erwrite a record.0e#er use pencil 6 all information should be

completed in permanent 1lac+ or 1lue in+

0o spaces, lines or elds are to be left blan+0e#er use s"mbols e.g ditto mar+s or arrows

to indicate repetiti#e and consecuti#e


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Bene)ts o# Good DocumentationPactice1uild condence in the Laborator" 7ualit" -"stem

!educe e*orts to compliance with regulator" bodies/llows for achie#ements of reuired results.

Correct, complete, current and consistentinformation e*ecti#el" meets customers and

sta+eholders8 reuirements.

nables the Laborator" acti#ities to be arranged into

functional patterns for specic action.

Create structures so that sta* can s"stematicall"coordinate to conduct business.

raining of Laborator" sta*.-ol#e complicated problems

!educe or eliminate assumptions and secondguessing.


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Bene)ts o# Good DocumentationPacticeliminate the need to reas+ the same

uestions-pecif" clear instructions for sta*