This application enables an electronic audit trail, making the complete process simple and paperless. It keeps the Quality Assurance (QA) personnel audit-ready at any time.
As per the 21 CFR Part 11, EU Annexure 11, ALCOA Plus and other regulatory guidelines, CaliberQAMS maintains audit trail for every transaction that a user executes.
CaliberQAMS provides the facility to track audit trail details event-wise to Quality Assurance (QA) personnel. All event details like registration, re-Initiation, modification, and status change will be available in the system. It reduces the burden of QA during internal and external audits.
Through audit trail feature of CaliberQAMS, complete user details and time stamps can be tracked easily. The system gives complete details from intimation of time at which a transaction started to when it was completed along with the details of who performed it. CaliberQAMS ensures complete transparency and on-time audit trail to take relevant calls of action.