Quality Assurance

Cogtest has an in-house quality management system ensuring that all our cognitive tests are designed, standardized, translated, validated, documented, data managed, and reported in compliance with protocol, SOPs, European GAMP-04 guidelines, HIPAA guidelines, and FDA 21 CFR part 11 regulatory requirements.

The Quality Assurance Department follows an independent, planned, systemic and ongoing quality assessment program covering quality management and organizational performance to ensure excellence in delivery to our clients.

The Quality Assurance Department performs regular and recurrent internal audits including: In-process (initiation, process and reporting stage of projects), Retrospective, and System Audits. These audits develop long term goals in an effort to prevent problems, anticipate challenges and provide continuous quality and improvements to our service.