Environmental Monitoring System Qualification

Continuous Monitoring of Equipment, Materials and Processes

  • Custom protocol consulting and development, or seamless execution of your own protocols.
  • Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.

 

Choose Masy for Accurate Calibration

Ensuring Compliance by Performing your Monitoring System Qualification

Contemporary environmental monitoring systems provide much more than audible and visual alarms for operators; most are fully computerized and offer automated electronic communication methods and additional features such as secure web-based access for authorized users.  Having an effective and dependable environmental monitoring system requires that the topology and configuration are appropriate for the application, along with a robust validation plan that ensures functional requirements and configuration elements are properly defined and verified.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Masy BioServices can support the validation of your environmental monitoring system project during all phases, from providing initial design review to generating the required project documents and executing the qualification protocols. We can work with you to create a custom protocol, or we will follow your Installation, Operational, and Performance Qualification (IQ/OQ) protocols in accordance with US Food and Drug Administration, current good manufacturing practices (cGMP) and other cGxP guidelines. We can help you develop:

  • IQ Protocols: Establishes that the chamber is properly and safely installed.
  • OQ Protocols: Verifies that the chamber consistently meets operational specifications such as alarms, controls, and operates as intended.

Contact Masy for Calibration

Quick Delivery of the Documentation Package

At the conclusion of your project, we will provide a clear, comprehensive validation report, confirming that your equipment is compliant to your standard operating procedures. Our validation reports contain all of the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurance practices, as well as cGMP and FDA requirements. 

Validation reports typically include:

  • Summary Report
  • Executed protocol
  • Validation personnel detailed résumé
 

Contact Masy for Calibration

Choose Masy BioServices for your Environmental Monitoring System Qualification Needs

When you choose Masy for your environmental system qualification projects, you can enjoy the confidence that comes with knowing that your critical systems are qualified to the highest possible standard, ensuring compliance with your SOPs and cGMP regulation – keeping your materials and products safe and effective.


Contact Masy BioServices today for your environmental monitoring system qualification needs.

 

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