QMS Validation Packages
At the center of your organization's Production, Materials, Facilities, Laboratory and Equipment & Process Control Systems lies your Quality Management System (QMS).
FDA's Quality Systems Inspection Techniques (QSIT) model emphasizes the critical importance of the QMS - the one system which is always inspected during either abbreviated or full inspections. Consequently, Life Sciences companies are increasingly taking a holistic view of their QMS rather than the fragmented; silo approach offered by many of the commercially available QMS software packages.
USDM's EQM system implementation and validation practice focuses on rapid deployment, improved quality and reduced / risk-based validations for all of our engagements. We achieve this through:
- Experience – a decade of EQM installation and validation projects.
- Risk-based approach to validation – a tried and tested method where the focus of the validation is on critical functionand modules that impact compliance data. All other functions that indirectly affect compliance data are minimally tested. This is documented in a detailed Risk Assessment.
- Validation Accelerator Packs (VAPs) for most standard EQM platforms - These VAPs are a complete set of content-rich validation document templates for the system based on common, core requirements for life science companies.
The VAP difference:
Each VAP lists requirements and tests for core and common system functionality and can be leveraged to build the validation documentation suite. The USDM VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance.
Among the common functionality (modules) covered in our EQM VAPs are:
- System access and security
- Corrective and Preventive Actions
- Incidents
- Change Control
- Continuous Quality Improvement
- Investigations
- Electronic signatures
- Audit trails
- Reports
- Workflow States
- Reporting
- Printing
USDM supports the following Enterprise Quality Management applications:
USDM works closely with its partners and vendors to identify upcoming patches and updates, and provides a full maintenance program for our EQM VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.
USDM has a dedicated, experienced validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.
Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of EQM validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.USDM has been successful across many EQM validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.
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"
