Xavor’s FDA Validations Solution not only provides medical and bio sciences companies with the build out of the protocol to meet FDA regulations but we will also manage and prepare your documentation as well as run it for you. Our services are based on the classic V-model as we have an extensive background in quality assurance and validation:
IQ – Installation Qualification
We evaluate your software and hardware that you are using with Oracle’s Capacity Planning Guide.
OQ – Operational Qualification
We verify all of your functional levels by making sure they are operating correctly.
PQ – Performance Qualification
After 30 days, we will ensure that your system is performing accurately.
- Validation planning and project management
- Software validation
- IQ/OQ/PQ Protocol development
- Test script authoring; execution, templates
- Creation of a Validation Summary Report
- SOP development, quality manual
- Regulatory compliance assessments
- Validation training