Meet Quality System Validation Requirements with Monnit

Monnit Remote Monitoring Solutions with Monnit Sensors and Gateways are multifaceted and allow you to accomplish many goals specific to your unique applications or use cases. Some applications have general requirements or qualifications that can simply be validated using the product data sheets for each sensor and gateway. Other applications require more specific use case qualification audits.

A standard set of such qualifications are Design (DQ), Installation (IQ), Operational (OQ), and Performance (PQ) for applications regulated by the U.S. Food and Drug Administration (FDA). While Monnit doesn’t generate application or use case-specific audit documentation, we provide a robust platform an onsite auditor can use to validate such qualifications.

Details

You can find the document regarding the FDA’s Quality System Regulation Process Validation at: https://www.fda.gov/media/94074/download

Design Qualification (DQ)

Monnit provides an off-the-shelf monitoring solution for many applications. We also provide data sheets to allow customers to design and qualify if the system or Monnit Solution will meet their particular application quality requirements. For many such applications, we offer sensors that will perform with the use case specifications that customers have; however, this does not apply to every use case.

Installation Qualification (IQ)

We can only provide product-specific installation user guides because our solutions or systems are designed for many different applications. We provide general installation best practices in our user guides and knowledgebase articles. For example, we recommend placing leads in freezers, installing sensors with batteries outside of coolers, and following antenna orientation instructions.

Operational Qualification (OQ)

To qualify, “Does it operate as it should?” you must perform an audit after the installation is complete. Although Monnit doesn’t offer installation audit services, there are third-party resources you can find to assist with such an audit.

Performance Qualification (PQ)

To audit, “Does it perform as expected under real conditions?” We can provide the product specifications, but this question refers to validating the solution onsite. With the specific details of each site varying greatly per site, you should explore or opt for third-party resources.



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