VMware qualification
USDM partners with VMware to provide Life Science companies with a best practice methodology for implementing VMware and conducting VMware qualifications. The VMware Infrastructure provides a qualified environment in which GxP applications can reside.
USDM provides a risk based, scalable and manageable Vmware qualification methodology that supports our clients’ infrastructure far beyond our initial engagement with them Going Beyond GAMP 5 (Plan, Specify, Build/Configure, Verify, Report etc.)
USDM goes beyond the routine deliverables of GAMP 5. Our approach ensures that the VMware qualification is scalable and manageable throughout the virtual infrastructure's life cycle by:
- Qualifying various common configurations (80/20 rule) to support future scalability of the infrastructure.
- Developing procedures for Change Control and deployment and testing master forms.
- Developing procedures and systems for ongoing Configuration Management.
- Qualifying other common network services that reside on the virtual infrastructure (e.g. database services, directory services, networking services, storage/backup services. etc.), thus eliminating duplication in GxP application validations.
USDM offers an Accelerated Qualification Package (AQP) that contains a reusable library of documentation templates for the VMware qualification effort and procedure templates for maintaining the VMWare virtual infrastructure throughout its lifecycle.
The USDM offering provides life science companies with an industry best practice tool to simplify compliance, increase productivity and minimize costs.
The USDM VMware Qualification AQP is based on common, general requirements for life science companies and contains the following documentation templates:
- Qualification Plan (Concurrent / Prospective)
- Infrastructure Requirements Specification
- Configuration Specification Template
- Risk Assessment
- Qualification Protocols (for VMware infrastructure and for common network services)
- Traceability Matrix
- Standard Operating Procedure Templates (Change Control, Configuration Management, Deployment, etc.)
- Qualification Report
"The USDM VMware Qualification Accelerated Qualification Package can decrease both compliance costs & project time by 50%"
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
