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Validation of SAP

Logistics QM

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Validation of SAP

Postby psrinivas » Thu Oct 24, 2002 7:07 pm

Hi

I would like to know the procedure for validation of SAP. as per USFDA software needs to be validated and complaince with 21 CFR.

is there any site provides information on how to validate SAP?

thanks in advance

psrinivas
psrinivas
 

QM: how to validate R/3 and per FDA et. al rules?

Postby Daniel Pereira » Tue Oct 29, 2002 10:38 am

Hi Psrinivas,
From my past experience, if one wants a proper R/3 validation as per
governamental audit agencies guidelines one should assume it as a
separate project while going through the R/3 implementation, handled by
dedicated/specialized people. The pitfalls are huge, the legislation and its
interpretations vary often, the stakes are high and one should regularly
go to some refreshing seminars to be aware if new rules/interpretations
apply.

Just to gather some references check:
http://www.sapinfo.net/public/en/index. ... 64dc2ec/en

If you are interested i might e-mail names of persons/companies with
whom i worked and will be in position to deliver a proper framework
and assistance.

Hope it helps.
daniel pereira
Daniel Pereira
 
Posts: 1490
Joined: Tue Oct 29, 2002 6:31 am
Location: Lisbon, PT

Validation of SAP

Postby psrinivas » Tue Oct 29, 2002 6:41 pm

daniel pereira

thanks for your info. I will go through that site. If you have any contact person names and address (preferably India) please send to my mail id psrija@rediffmail.com.

once again thanks

psrinivas
psrinivas
 

SAP validation contacts

Postby Daniel Pereira » Wed Oct 30, 2002 7:47 am

I sent you some contacts to the given e-mail. For the public record i
worked with BOVIS Pharma before and i am in position to recommend
them as a trustworthy and professional partner:

http://www.bovislendlease.com/pharmaceutical
http://www.bovislendlease.com/llweb/bll ... /sv_valid_

Hope this helps. Regards,
daniel pereira
Daniel Pereira
 
Posts: 1490
Joined: Tue Oct 29, 2002 6:31 am
Location: Lisbon, PT

SAP validation Contacts

Postby psrinivas » Thu Oct 31, 2002 1:14 am

daniel pereira

thanks a lot

psrinivas
psrinivas
 

sap validation as per 21 CFR part11

Postby sanjay » Thu Oct 31, 2002 7:14 am

Hi Srinivas

Intelligroup has experience in SAP validation as per 21 CFR part 11 & we have developed one solution called ( Pharma Express) it is certified by SAP also if you want more details about this product just go to Intelligroup web site.

http://www.intelligroup.com

sanjay
sanjay
 

Validation of SAP

Postby psrinivas » Mon Nov 04, 2002 9:47 pm

Thanks a lot Sanjay

regards

psrinivas
psrinivas
 


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