QM in regulated environment

[Former Member]

Hi Guru's

In FDA regulated industries what are points to be consider while implementing QM module?

I know the Digital Signature.

Throw some lights

Thanks

Sami

[Former Member]

close the issue

[Former Member]

[What Happen to this thread?????|;

Regards,

Shyamal

[Former Member]

Hi

I think besides system function, there are alot of procedure need to follow during the implementation process. I remember we need about ten documents from beginning til go live for one process to be implemented, not talking about changes incur along the way. This is for pharma industry.

In term of SAP QM function, besides then the UD signature, there is nothing specific that we need to follow. Of course security/authorisation control is very important.

dannysao

[Former Member]

HI Danny

Thanks Danny And Shymal for your past response.

Can you please explain in detailed about that 10 documents, which will be more helpful to me..

thanks

[Former Member]

Hi

I cannot help you more on the FDA, as of I did not go thru the formal FDA training. I also not sure what you mean of 10 documents.

dannysao

[rupesh_brahmankar3]

Hi Sami,

Please refer these link,

[Digital Signatures|https://www.sdn.sap.com/irj/sdn/go/portal/prtroot/docs/library/uuid/40f6fee6-9316-2a10-d2a9-954d4df7dd33]

[Digital Signatures Application|https://www.sdn.sap.com/irj/sdn/go/portal/prtroot/docs/library/uuid/55ba9790-0201-0010-aa98-ce8f51ea93cd]

Regards,

R.Brahmankar