Challenge
This Fortune 100 consumer products company needed to ensure that all of its facilities complied with new FDA regulations, particularly 21 CFR Part 11.

Solution
Conducted a computer system validation assessment of all affected systems and departments. Integrated all validation assessment activities into current business and IT initiatives and created a compliance validation plan. Built a Compliance Program Management Offi ce to direct internal regulatory processes and help executives understand which regulations apply to the home and personal care industry.

Benefits
The company is now fully educated and prepared to meet FDA requirements and implement a firm-wide compliance strategy that includes:

		Enterprise documents for interpretation of 21 CFR Part 11
		Cost/risk matrix for corporate systems validation
		Corporate training plan

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