Montrium’s Audit Management application allows life sciences organizations to identify operational & compliance risks through structured audit information. Based on industry standards and best practices, the audit management module is designed to assist auditors in the planning and execution of audits through the use of workflow based tasks and integrated GxP audit checklists. Audit observations can be easily captured, tracked and trended both for internal and external audit thereby eliminating time-consuming paper-based processes.
Pairing the Audit Management solution with the implementation of the CAPA Connect, life science organizations can improve the tracking and trending of quality issues as they happen. Although this is the scenario most strive for, it is only really with an integrated quality management system and a holistic approach, that this can be achieved.