Contract organizations spend a disproportionate amount of time participating in sponsor audits, on top of regulatory audits. These 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 Driving Business & Quality Success with an Integrated QMS Platform, which outlines how to take control of your quality processes including Complaints, CAPAs, Deviations, Change Control and Audits:
- Audit creation
- Form filling, workflow execution
- Root Cause Analysis
- QA Approval
Or if you are interested in using SharePoint 2010 as your QUMAS, download this webinar on Qualifying SharePoint 2010 and Delivering a 21 CFR Part 11-Compliant Quality Management Solution