Welcome To QVEX Consulting

Developing effective compliance solutions in today’s regulatory environment

Quality • Validation • Excellence

Master Validation Plan (MVP)

Master Validation Plan (MVP)

The MVP is a document, or group of documents that detail and discuss the validation activities and compliance requirements within regulated business such as manufacturing, tissue banking, medical device, pharmaceutical and biotech companies. The underlying message of...

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Environmental Monitoring

Environmental Monitoring

A robust Environmental Monitoring Program is essential to the success of maintaining a successful quality program. A good program should consist of controls that monitor both viable and non-viable particles at all times. At QVEX Consulting, we can help you develop...

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Sterilization

Sterilization

  At QVEX Consulting, we provide the following sterilization services:   Development of validation protocols Coordinating protocol execution Review of the data to ensure compliance with applicable standards such as AAMI/ISO. Development of validation reports...

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Quality

Quality

A robust quality program is crucial to ensuring regulatory compliance.  Per FDA, "Quality cannot be adequately assured merely by in-process and finished-product inspection or testing." At QVEX Consulting, we provide the following quality services:   Development...

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Cleanroom Certification

Cleanroom Certification

A cleanroom is a controlled environment that us typically used for the manufacturing of items that require a low count of environmental particulates. Cleanroom's must be certified to meet the standards set by the International Standards Organization (ISO) in...

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