Internal, External, Regulatory and Supplier audits play a number of important roles:
- Providing information for decisions being made within the organization
- Ensuring regulatory compliance – by internal or external audit
- Checking that operations and procedures are within stated SOP operations
- Gaining sponsor recognition and acceptance of protocols and procedures
The QUMAS audit management solution provides an integrated software system that is designed to meet the varied regulatory standards associated with a global supply chain. The solutions is scalable, whether you are auditing clinical studies for GCP requirements, configuring templates and workflows to match unique management requirements, or auditing a supplier for compliance to your corporate quality standard or an internal department in preparation for an ISO 9001 audit. The QUMAS Audit software allows auditors to plan and execute audits more efficiently using an integrated tracking system and workflow engine automating the audit lifecycle including scheduling, preparation, auditing, report approval, report issuance, response and corrective action (CAPA) tracking.
The Audit solution from QUMAS ensures 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 Audit 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 QUMAS Quality Management Solution for Global Regulatory Compliance, 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
"QUMAS products have helped Hollister be a more nimble company," said Dawn Porter, Compliance Process Lead at Hollister. "We now have much better visibility of compliance activities across the entire company and can see how a problem in one facility could potentially impact additional facilities, and then take the required steps to prevent the problem from occurring globally."