Electronic Data Systems

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(No Transcript)
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Electronic Data Systems
Tools or Toys?
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General Guidelines
One Companys Ideas
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General Guidelines
Tools Reduce Inputs Of
Money
Energy
Time
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General Guidelines
Toys Cost
Toys Dont Reduce
BUT..
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General Guidelines
Toys Can Give the Perception That Your Company
is..
"High Tech"
WeDaBestCompany,Inc. prepares to launch their own
GPS satellite
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General Guidelines
Remember. A good GLP trial CAN be conducted
with a bound notebook
But it takes a LOT of
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General Guidelines
Selecting Software
Is it familiar to
Your Staff
Study Directors
Sponsor/Middle Management
EPA
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General Guidelines
Selecting Software
Can you cut-n-paste into
Advantage eFTN
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WARNING!
Will the electronic data forms be GLP compliant?
EPA will require
Validation
Whats That??
Depends on who you ask.

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. Which QA person has the RIGHT answers??
No Way!
Not a Problem
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One Companys Ideas
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One Companys Ideas
Selected Software
Excel 97

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One Companys Ideas
Forms in Excel
Farm Maps
Plot Maps
Area Maps
Test Substance Calculations
Sprayer Description
Calibration Verification
Sampling Forms
Weather Records
Plot Maintenance Records
Pesticide Histories
Equipment Maintenance Records
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One Companys Ideas
Area Map
Enter trial info.
Print out
Sign date.
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One Companys Ideas
Pesticide History
The only way to manage.
_at_30 lines of data for every year for each of
12 vineyards 53 orchards for 10 years
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Plot Map
One Companys Ideas
53 orchards and 12 vineyards with permanent
markers(trees, vines)
Just add trial data to map, print, sign date
Sponsor Study 2002DSA Sponsor Trial 37-78-9
ACDS Trial AR0267
Check Plot 1 Row x 8 Trees 20 Ft. x 120 Ft.
White Ribbons
Treated Plot 1 Row x 8 Trees 20 Ft. x 120 Ft.
Blue Ribbons
250 Feet
Map Created by_____________
Date_______
I.M.Techman
10/19/99
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One Companys Ideas
Creating Worksheets
Match to your SOPs
Create, check, correct,
check, correct,
check, correct
Field test
Verification by independent QA
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One Companys Ideas
Creating Worksheets
Verification by independent QA
Computer can print asignificant number..
10.2
Computer stores actual number..
10.156695439872
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WARNING!
Dont round off numbers when verifying
calculations!
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One Companys Ideas
Sprayer Calibration Template
Enter trial info
2002DSA35-78-9
AR0267 00JD-06
Enter sprayer info
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20 100
20 2
Enter plot info
100
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One Companys Ideas
Computer has calculated information in blue
Print out worksheets
Hard Copy
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One Companys Ideas
Computer Calculations
Fill in template for
Save to Zip or floppy disc
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One Companys Ideas
Its Application Day. With QA!
Get hard copy of calibration sheet
QAs laptop
Copy of calibration spreadsheet to QA
Sprayer setup Cards to QA
Need Multi-lap Stopwatch
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One Companys Ideas
Use stopwatch to record 3 sprayer outputs
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Enter data on hard copy
45.03
5.0
44.87
5.0
45.13
5.0
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Enter data in computer
Computer calculations in Blue
45.03
45.03
45.03
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Enter data on hard copy
420.5
5.0
6.7
5.0
5.0
5.0
4.84
45.01
20.67
20.67
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One Companys Ideas
Use stopwatch to record 3 sprayer speeds over a
set distance
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Enter data on hard copy
20.45
20.73
20.83
B1
1550
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Enter data in computer
Computer calculations in Blue
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4.84
3.30
X
I.M. Techman
10/29/99
Enter data on hard copy
x
Check, sign, date
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One Companys Ideas
Mix, go to plot, set RPMs with practice passes
Record actual plot pass times during application
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Application verification section on hard copy
20.62
20.88
Enter plot pass times
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DO NOT SAVE
Enter data in computer
Computer calculations in Blue
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Enter data on hard copy
41.50
20.75
4.82
3.29
4.61
100.4
100.4
1.00
X
I. M. Techman
10/29/99
Check, sign, date

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A signed, dated sheet with original hand-written
entries!
QA is..
HAPPY!
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Electronic Data Systems
Choose tools, not toys
Selecting Software
Familiar to your customers
Designing Forms
GLP compliant
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