We provide Computer Systems Validation services to regulated industries such as Pharmaceuticals, Biotechnology & Medical Devices.
CSVQA can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the Software Life Cycle (SLC). We have drafted (and executed) commercially available validation packages. We can provide any level of services required, from executing test scripts generated from your existing specifications to writing the entire validation deliverables.
We can perform Annex 11 and Part 11 Assessment for all computerized systems and identify compliance gaps.
CSVQA will provide SOPs that your group understands and can follow to ensure regulatory compliance.
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