Validation Packages for EQM SystemsAt 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:
EtQ Quality Management
