Validation

Our Client: A large Midwest University Medical School was contracted by an international manufacturer to conduct a clinical trial for a new product designed to reduce cavities in dental patients.

The University was utilizing electronic data collection for the clinical study. This included data entry using pre-constructed forms on a tablet PC, upload to the new form application server, and transfer and storage of the data for subsequent bio-statistical analysis.

Safis Solutions was engaged by the university to provide computer system validation services. Safis provided validation direction and oversight for the new computer data system. The team assisted with the creation of validation documentation and ensured that all aspects of the electronic data collection were 21 CFR Part 11 compliant. Further, Safis qualified the new server, which held the application software for the forms. Finally, the team conducted an audit of the forms software vendor whose product was used in the data collection process.

The data system was validated to 21 CFR Part 11 standards, and the clinical study was executed successfully.