Bioequivalence and Bioavailability Forum • software update

Ramesh
☆

India,
2010-03-05 18:15
(5545 d 04:32 ago)

Posting: # 4867
Views: 5,661

software update [GxP / QC / QA]

Dear all,

I have one query regarding the requirements when the software is update. For example i had carried out the validation in analyst 1.4.1 now i upgrading my software to analyst 1.5.

now what are the requirements or documents to generated in compliance with the regulatory.

whether i have to prove the precision and accuracy batch after installing the updated software.

please correct me if am wrong.

advance thanks,
ramesh :ok:

—
with regards,

Ramesh

Debbie
★

India,
2010-03-07 17:09
(5543 d 05:38 ago)

@ Ramesh
Posting: # 4870
Views: 4,576

software update

Post reply

Hi,

are you sure your software is updated?
or
your software is changed from version 1.4.1 to 1.5?
i have a few questions to answer your query:

why you want to update/change your software?
if it is updation of software, is the previous version of the software not functioning well?
Do you have the list of changes between the two versions?
what is vendor (applied bio systems) is suggesting to do?

if the software version is updated or changed, you should evaluate the complete operational and performance qualification of the software.

performing a Precision and accuracy batch does not help in any context, it only indicates the performance of the individual method with your new software, then what about other methods performing on the same system?

Regards,

Debbie.

Ohlbe
★★★

France,
2010-03-08 00:35
(5542 d 22:11 ago)

@ Ramesh
Posting: # 4873
Views: 4,606

software update

Post reply

Dear Ramesh,

❝ For example i had carried out the validation in analyst 1.4.1 now i upgrading my software to analyst 1.5.

❝

❝ now what are the requirements or documents to generated in compliance with the regulatory.

The requirement is you have to validate your software...

❝ whether i have to prove the precision and accuracy batch after installing the updated software.

... and not to validate a specific method, or just perform one run and say "OK, it works".

Regards
Ohlbe

Ramesh ☆ India, 2010-03-08 08:26 (5542 d 14:21 ago) @ Ohlbe Posting: # 4876 Views: 4,605	software update Post reply
	Dear Ohlbe, Thanks for the reply. After updation of the software complete validation has been performed. In order to go for a update software, the software has been updated. once againg thanks for reply and suggestions. Ramesh.V — with regards, Ramesh