Medical Device organizations spend a huge amount of time auditing themselves and their suppliers, or responding to audits that their customers and regulators conduct on them. Audits are an important element of compliance and exist to ensure independent review of systems and processes to alert to conditions that may become future issues. By using the automated Audit Management Solution from QUMAS, organizations can ensure that all non–conformances, observations and recommendations are recorded, tracked, updated and resolved in compliance with the time lines expected by the auditor or as required by law.
Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS Audit Management process, allowing for observations to be recorded, reported and tracked for closure with an action plan executed to the satisfaction of both parties.
For more information on managing Audits, internal or external, using the QUMAS solution, download this webinar on Best Practice Deviation, CAPA, and Change Control with BIOVIA QMS, which outlines how to take control of your quality processes including Complaints, CAPAs, Deviations, Change Control and Audits.