Installation, Operation and Performance Qualification

//Installation, Operation and Performance Qualification
Installation, Operation and Performance Qualification 2018-02-03T13:46:57+00:00

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.

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Operation Qualification

  • Perform operation qualifications in timely manner

  • Confirm that equipment is operating as expected within process window

  • Create clear documentation with electronic approvals

Operation 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.

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Installation, Operation 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.

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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.
Galen Swindell, VR Analytical
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.
Magdalena Czarnievicz, Otoharmonics
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.
Mandy Cameron, SerĂ¡n BioScience

Novunex helps to increase your competitiveness

Qualification processes are closely integrated with Equipment management allowing for precise planning and execution of qualifications with fully electronic records.

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