Benefits of implementing SAP GRC AC in Lifescience/Pharma.

[Former Member]

Dear All,

Would be great if anyone could please share the benefits of implementing SAP GRC Access Controls in Lifescience/Pharma industry, more specifically which all regulations and laws it takes care of.

Regards,

Hersh.

Edited by: HERSH GUPTA on Dec 18, 2008 6:04 PM

[Former Member]

Thanks a lot for your views.

[Former Member]

Hersh,

Look for some of the Success stories out there. That should help you. Below is one of it.

http://www.securintegration.com/fileadmin/redakteur/binary/Success_Story_KRKA_SI.pdf

I too work at a Pharma client and having AC in place really helps. CC will help the internal SOX and audit team to verify that there are no SOD's. RE can streamline the role change approval process which will be of a great help when you see it from a auditor prospective. (You will always have the right approvals for the role changes a developer makes) and AE will help you reduce the paper work and the biggest advantage is the right approvals. Before using AE we used to have the paper based access request and we used to get a lot of audit issues because of the people approving roles that doesn't fall under their own space. (which will be taken very seroiously if it is a Pharma company.) FF advanages reamins the same across the industries.

Hope this helps,

Naveen

[Former Member]

Hello Naveen,

Thanks for your reply. The site you have refereed is too usefull too. However, the advantages that you have mentioned in your forum post would be the general advantages of AC suite, not only for the Pharma sector. Whereas, what I was specifically looking for was for something on how AC takes care of the Pharma sector regulations and laws, which makes AC sellable to a Pharma client. What all regulations it covers in the phar,a industry and stuff like that. Would be great if anyone could refer something on this as well.

Thanks & Regards,

Hersh.

[Former Member]

GRC solutions help companies meet a growing list of compliance requirements, such as the Sarbanes Oxley Act (SOX), Food and Drug Administration (FDA) regulations for pharmaceutical companies, and Basel II regulations for the banking sector.

Following links can answer you question fully.

[GRC for Life Sciences|http://www.sap.com/industries/lifesciences/large/compliance.epx]

[Environment, Health, And Safety Compliance Management|http://www.sap.com/solutions/business-suite/erp/corporate_services/featuresfunctions/ehs/index.epx]

Best Regards,

Amol Bharti

[Former Member]

Hersh,

I know my answer was kind of general for all the companies but that is what GRC suite does right.. It is same across the board. The main selling point for using GRC AC for Pharma will be the automation of SOX compliance and better regulation which helps a lot for the Pharma industries because of the regulations they have to follow like FDA... One more thing is If a client has SAP already up and running it makes sense to have the Compliance tool from the same vendor because it will be supported well and it is integrated well with SAP as it is a SAP product (now).

Naveen

[Former Member]

Hi Amol,

Thanks for ur reply. The first SAP link was quite helpful, though the second talks about EHS, whereas I was looking for Ac in particular.

Regards,

Hersh.

[Former Member]

Helo Naveen,

Ya thats true but again what I am looking for is the info and example like in the example below:

ACT/Regulation XYZ says "Process -abc- should be followed" and for this use Access Controls because it does takes care of process abc, thus making you complaint for ACT/Regulation XYZ.

One of such examples is the SOD, which most of us are aware of. In this case AC generates rules for SODs and these are then taken care of. Are there any others like the SOD? If, yes, what are they and how does AC takes care of them. For example are there any regulations for ser provisioning/role assignments which we can consider as a solution provided by AC for the pharma sector?

Regards,

Hersh.