QM in regulated industries

[Former Member]

Hi Guru's

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

Throw some lights

Thanks

Sami

[Former Member]

Hi Sami,

Find the links, may help you.

[RossInc|http://www.rossinc.com/aview.aspx?id=1895]

[Complying with U.S. FDA 21CFR PART11 For Lifesciences Ind.|http://www.sap.com/industries/lifesciences/pdf/BWP_FDA_title21.pdf]

[ Validation of SAP R/3 and other ERP systems: Methodology and tools |http://www.encyclopedia.com/doc/1P3-65215687.html]

Regards,

Shyamal