Risk Assessment

THINQ performs Risk Assessment at the system level, process level, and functional level. System risk assessment is used to determine the system compliance approach. Process risk assessment is used to determine whether further risk management activities are required at the functional level (for example any business process configuration). Functional risk assessment is used to adjust the test scope of the individual functions to ensure that the correct amount of testing is performed.

On all engagements, THINQ uses its unique compliance management software TCM (THINQ Compliance Manager). This software when integrated with THINQ services affords the opportunity to individually weight critcial regulatory requirements faced by an organization. The linking and traceability features of the software ensures that all regulatory requirements are satisfied, effectively guaranteeing no negative audit findings.

A number of THINQ customers have now utilised THINQ's integration of software and services and they too have experienced positive regulatory audits.

THINQ generally follows ISO 14971 and the GAMP model for Risk Assessment