Re: Does Ariba SLM comply with FDA

Thanks Vilas. Yes I am referring to SIPM and contract management

1) The 21 CFR part 820.70 i , is under Quality System Regulation-->Production and Process control and states that "

Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. "

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.70

Q: Does comply to above regulation and how (which features)?

2) 21 CFR part 11 details out how electronic records and signatures are processed, accessed etc

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

Q: Does Ariba comply to 21 CRF part 11 and how (which features?)

Thanks,

S