DOCUMENTATION

Sunando Basu M.Pharm (Quality Assurance), RQAP-GLP

Head Quality Assurance- VIVO BIO, Hyderabad

 KEY QUESTIONS?

Why it is so important?

What if I dont document?

What do we mean by document?

What are the requirements of documentation?

How can I fulfill the requirements?

What should I remember?

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 WHY IT IS SO IMPORTANT???

Documents are the Life-blood of the Organization!

Demonstrate what actually went on at the time

Critical for complete reconstruction of the study

Authentication that all the required procedures were correctly carried

out at the correct time

Regulatory requirement

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WHAT IF I DONT DOCUMENT???

Experimental data are lost

Complete record is not made

Lost/ Incomplete document may invalidate study

Impossible to justify as the usual believe is

Regulatory action

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 WHAT DO WE MEAN BY DOCUMENT?

Descriptive document

Results of original measurements, observations, and activities

associated with the study which may be needed to verify and evaluate the
study

Which will provide a picture of what actually happened during the course
of an activity

Examples are: Raw Data in Laboratory Notebook, Logbook,

Forms, Project Binder/File,

Paper Printout, Electronic Format, All

type of records
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 DOCUMENTATION TYPE

Handwritten Electronic Data

Documentation Capture

Entry Into Transcription of

Electronic System Paper Records
To Computer
Copying Raw Database
Data

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WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?

Identifiable

Promptness

Accurateness

Legibility

Signature and Date

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WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?

Therefore the document should show:

What was done

How it was done

When the work was performed

Who performed the work

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HOW CAN I FULFILL THE REQUIREMENTS?
Record data

Directly into the required format and not transcribed from

a rough copy

Promptly

Accurately

Legibly
Then
Sign and date

Note: Sign indicates who has performed the work and

date identifies when the work was performed
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WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?

Any correction made during and or latter recording should be

explained for

Reason for correction

The signature of the individual making the correction

The date the correction was made

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 HOW CAN I FULFILL THE REQUIREMENTS? Contd..

Therefore, remember to

Make a single line through the error

Record the correct entry on the above or next to the

original entry with the reason for correction

Then Sign and date

Note: Correction codes can be used to simplify the explanation but shall
be clear to the third party

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 HOW CAN I FULFILL THE REQUIREMENTS? Contd..

PRACTICE THIS

276 275 Error in writing SB 31-10-2006

Correct Reason for Sign and

Entry Correction Date

AND NOT THIS

276 Over writing

276 Scribbling
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 WHAT SHOULD I REMEMBER?
Documentation

Paramount importance

All information blanks that require data input must be completed

Record data to its completeness

Never assume that something written in SOP or Protocol are not

required to be documented

Always sign and date

Never indulge in Fraudulence

Follow companys SOP on Good Documentation Practice at all time

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Never discard original record
 BOTTOM LINE

Documentation Constitutes An Essential Part Of

T h e Q u a l i t y M a n a g e m e n t S y s t e m

Should show complete History of AUDIT TRAIL

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