Installation Qualification
Consistently perform installation qualification as determined
Verify if equipment is correctly set up
Create audit trail that installation qualification was performed
Installation qualification ensures that the setup of the equipment is correct and connected to the infrastructure. Installation qualification can prevent expensive downtime and/or equipment damage.
Operational Qualification
Perform operational qualifications in timely manner
Confirm that equipment is operating as expected within process window
Create clear documentation with electronic approvals
Operational qualification confirms that the equipment is producing compliant products within the boundaries of the predetermined process.
Performance Qualification
Completed performance qualification on predetermined plan
Create evidence that equipment performs as determined
Create comprehensive qualification record
Performance qualification ensures that a compliant product is produced under different conditions like different production shifts or other production teams.
Installation, Operational and Performance Qualification
Determine re-qualification needs when equipment change is performed
Easily find qualification status and records
Put recurring qualifications on an automated schedule
Close integration with equipment management ensures accurate data and timely re-qualifications if determined.
Best choice for equipment qualification
Novunex has over 10 years experience in creating qualification systems
Thorough understanding of qualification requirements and consequences of non-qualification
Experience in auditing and improving qualification systems
Equipment qualification with Novunex
Fully integrated with equipment management
Qualification processes are closely integrated with equipment management allowing for precise planning and execution of qualifications with fully electronic records.
Electronic execution, review and approval of qualification tasks
Quality Managers carry a great deal of responsibility in ensuring that our respective organizations maintain regulatory compliance while also exhibiting a robust quality culture. They simply provided what was needed and made recommendation that ultimately made sense for our business needs.
We have gone through one ISO 13485 surveillance audit and our auditor was very happy and impressed with how the system works. The system has also helped us improve our traceability, and having more robust records.
The customer support is unmatched in the eQMS industry and the system is very flexible, and encompasses all manufacturing quality processes above and beyond the standard document control offerings.