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Installation Qualification
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|
7
|
1395
|
November 21, 2008
|
|
SAP configuration specification GAMP5
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|
3
|
1969
|
November 20, 2008
|
|
Compliance of Pre-clinical software
|
|
1
|
610
|
November 5, 2008
|
|
Non-Conformances to the URS
|
|
3
|
970
|
October 24, 2008
|
|
SAP validation
|
|
1
|
762
|
October 9, 2008
|
|
--urs--
|
|
1
|
804
|
October 8, 2008
|
|
Calculator Validation
|
|
1
|
3234
|
October 2, 2008
|
|
Article of the month Jan 08
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|
7
|
1102
|
September 13, 2008
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|
Is all software GAMP5
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8
|
1156
|
September 2, 2008
|
|
Software upgrade procedures?
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|
2
|
825
|
July 31, 2008
|
|
Reg-Validation Approach
|
|
1
|
553
|
July 30, 2008
|
|
Excel Passwords
|
|
1
|
576
|
July 16, 2008
|
|
SAP retrospective validation
|
|
2
|
645
|
July 4, 2008
|
|
Reg-output fromthe system
|
|
1
|
679
|
June 25, 2008
|
|
Is there any software?
|
|
4
|
1017
|
June 7, 2008
|
|
Practical question : Locked/Unlocked cells check
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|
4
|
1121
|
May 30, 2008
|
|
IQ or OQ...?
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|
3
|
850
|
May 29, 2008
|
|
Need for an IQ Report?
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|
3
|
954
|
May 19, 2008
|
|
Software design specification SDS question
|
|
4
|
1899
|
March 27, 2008
|
|
Decommissioning Plans and Reports
|
|
5
|
3069
|
March 10, 2008
|
|
URS details
|
|
13
|
1270
|
February 11, 2008
|
|
Cat 3 & cat 4 spreadsheets... when is URS? FS? DS?
|
|
5
|
1508
|
January 22, 2008
|
|
What to inclede in making IQ/OQ/PQ of software validation
|
|
2
|
687
|
January 10, 2008
|
|
Remediation strategy for spreadsheet?
|
|
1
|
668
|
December 18, 2007
|
|
URS Vs FS
|
|
3
|
4192
|
December 3, 2007
|
|
What do you include in your OQ
|
|
2
|
790
|
December 3, 2007
|
|
Signatures on Reports
|
|
5
|
1110
|
November 28, 2007
|
|
What do you include in a IQ
|
|
3
|
889
|
November 28, 2007
|
|
Hybrid System Qualification
|
|
1
|
905
|
November 27, 2007
|
|
looking for more info on COTS validation
|
|
1
|
634
|
November 20, 2007
|