Data Acquisition and Retention System Qualification

  • 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 Data Management System Qualification

The capture, storage and retrieval of operating conditions for process equipment and controlled environments is a critical element of compliance in pharmaceutical and biotech industries.  With the evolution of computer technology, legacy paper-based systems are increasingly being replaced with electronic software-based systems which require minimal maintenance while also providing much greater fault tolerance and capabilities.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

Based on your standard operating procedures (SOPs), Masy BioServices performs precise thermal, humidity, pressure, and carbon dioxide environmental chamber mapping, empty chamber thermal distribution, and load penetration studies with in-depth analysis. 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 system is properly and safely installed.
  • OQ Protocols: Verifies that the system 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 Data Management System Qualification Needs

When you choose Masy for your data management 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 data acquisition and retention system needs.

 

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