Risk Management begins with our compliance expertise. 20+ years of it to be exact. We approach every engagement with the validation rigor that is commensurate with the intended use of the system, regulatory requirements, technical complexity, business risk, and data integrity risk.
Our auditing team conducts cloud and on-premise software vendor assessments, PAI audits, GXP readiness, Inspection readiness, 3rd Party audits, and audits specific to regulations such as UDI, DSCSA, Part 11, and many others. Our Compliance Center of Excellence leaders are comprised of ex-Agency personnel who successfully remediate customers in any stage of agency scrutiny.
Want to sleep better at night knowing your GxP processes and applications are properly qualified and validated? Give us a call.