Our engineers generate master validation plans and reports, gather functional requirements and specifications for Installation Qualification, apply Taguchi fractional factorial experimental designs for Operational Qualification, and execute Performance Qualifications (Product and Process) expertly.  Software validation services are also available.

We are skilled in generating protocols and reports, complete with statistical data analysis, that have passed muster with the FDA and the European Union’s Notified Bodies. Leveraging industry’s “best practices” and a sense of urgency, we do it right the first time.

Process validation and design verification begin with risk assessment that complies fully with ISO 14971, and end with risk mitigation including validated control plans and full documentation. Our sights are set on optimizing your manufacturing processes and design parameters.

Please contact one of our Validation Services representatives at Validation@GCIBiotech.com.