Documente Academic
Documente Profesional
Documente Cultură
in GXPs
If It Isnt Documented,
It Didnt Happen.
Presented By:
Validation Plus, Inc.
14 Penwood Rd.
Livingston, NJ 07039
www.validationplusinc.com
(866) 760-2483
Course Objective
To increase the level of awareness on the
Definitions
Document - the record that describes how an
Why Is Documentation
Important?
Identifies Roles, Responsibilities and
Requirements
Creates an Audit Trail
Serves As Evidence
Details the Event
Historical view of activities
Remember. Documentation is what remains
Why Is Documentation
Important (Contd)?
Comply with regulations
Provide a standard for
Why Is Documentation
Important (Contd)?
Reduce errors
File and defend patents (for
research/development) successfully
Prevent fraudulent behavior
Commonalities???
work of art
expensive
object of high quality
no information
available on how it
was created
work of art
expensive
object of high quality
no information
available on how it was
created
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Practices To Internalize
In our business we must:
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Repercussions
Injury or death to consumer
Company reputation - industry, regulatory
agencies
Stockholders
Reduced company revenue
Your job
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completeness
you have agreed to any conclusions
you support the information
you are taking responsibility
your signature is legally binding in a court
of law
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Written Procedures
Written procedures must define
Documentation Practices
All GXP Documents must:
Be current and approved - never use deleted
or obsolete
Define scope and purpose
Be clearly stated and followed
Have revision or version number, if
appropriate
Have an issue/effective date, if appropriate
Be easily retrieved
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Entering Information:
Enter information using only permanent ink (no
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Approvals/Verifications:
ALLOWABLE:
One individual performs an action. A second
individual approves or verifies that action. The
result is completion or confirmation of the
specified action.
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correction.
A note(s) to explain a correction(s) are entered on the
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considered falsification?
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Falsification:
Altered data
Falsification:
Entering data when testing or other activities
name.
Using other than todays date where
Falsification:
Changing original / non-retrievable data without
supporting documentation.
Destroying original documentation or data.
Documenting verification of data without
INDIVIDUAL observation.
Entering or approving data / information using
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Consequences of Falsification:
Falsifying data or intent to conduct or
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Consistent
Legible
Complete
Accurate
Direct
Prompt
Truthful
Clear
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BREAK ?????
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Group Observations
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Group Activities
Break up into groups of 3-4 people
Select a spokesperson
Identify documentation errors on provided
examples
Present them to
class
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In Summary ...
Documenting your work speaks to the
In Summary ...
Data must be clear (so everyone who reads it
In Summary ...
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Remember...
Learning Assessment
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Multiple Choice - #1
The main purpose of a record or document is to:
A)
B)
C)
D)
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Multiple Choice - #2
The phrase, so everyone who reads the
Legible
Accurate
Direct
Clear
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Multiple Choice - #3
The (US) standard way (s) to record time uses:
A)
B)
C)
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Multiple Choice - #4
The ink to be used when recording data is:
A)
B)
C)
D)
Blue or Black
Erasable
Water soluble
All of the above
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Multiple Choice - #5
An explanation for a recordkeeping error is:
A)
B)
C)
D)
Not needed
Needed only when the reason is not
obvious
Needed for all records
Needed only for GLP records
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Multiple Choice - #6
Properly prepared documents can:
A)
B)
C)
D)
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Multiple Choice - #7
Document entries must be made:
A)
B)
C)
D)
Multiple Choice - #8
You are handed a document by your manager
Multiple Choice - #9
Which of these records are not GXP records?
A)
B)
C)
D)
E)
Equipment logbooks
Approval of Components
Packaging and Labeling
Financial reports
Production or Processing
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