Services for Validation PackagesThe USDM Compliance Team provides subject matter expertise and regulatory expertise to ensure that computerized systems meet both regulatory and business requirements. Our teams can provide ongoing support to ensure systems maintain the validated state.
- Services offered in support of validated systems:
- Periodic Review Process
- System Audits
*Review open issues
*Review changes to system
*Review business process changes
*Determine status of system updates and patches available
*Change control
- Vendor Audits
- System Assessments
- Risk Management
- Risk Assessment
- Vendor Selection Services:
*Gather and document user requirements
*Sponsor vendor demonstrations
*Assist with preparing RFQ
*Assist with system selection
