Shastris
☆    

2010-05-18 20:28
(5881 d 20:26 ago)

Posting: # 5351
Views: 3,267
 

 software change [Bioanalytics]

Dear all,
Method has been validated with one version of the analyst software (say 1.4.1) and subsequently, before study analysis, the software version is upgraded to 1.4.2. Software validation of version 1.4.2 performed successfully

Before initiation of subject analysis, is some kind of partial validation required and if so, how much?

Regards,
Shastri
Ohlbe
★★★

France,
2010-05-18 23:35
(5881 d 17:19 ago)

@ Shastris
Posting: # 5352
Views: 2,788
 

 software upgrade

Dear Shastri,

As long as you have validated the computer system with the new software version, and are using similar integration and quantification parameters (same integration algorithm, same type of regression), no need for a partial method validation.

Regards
Ohlbe

Regards
Ohlbe
Helmut
★★★
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Vienna, Austria,
2010-05-18 23:44
(5881 d 17:10 ago)

@ Shastris
Posting: # 5353
Views: 2,743
 

 Analyst 1.4.2

Dear Shastri,

since I validated Analyst 1.4.2 myself last month - a question out of curiosity: How did you do it?

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