Process Control 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 Control System Qualification

Process Control Systems are the engines of production facilities in pharmaceutical and biotechnology manufacturing. From a quality control perspective, the process control systems and associated equipment are second only to the human operators and personnel toward ensuring manufacturing success and compliance.
 
System types can range anywhere from a single skid-based programmable logic controller (PLC) to large and complex distributed control systems (DCS) and supervisory control and data acquisition systems (SCADAS) that centralize management of control and communication between multiple control systems.

 

Masy's Approach to Calibration

The Correct Qualification Protocol for Your Specific Requirements

System elements can vary greatly depending on the size and application. The physical components and software/firmware types that comprise process control systems are very diverse, but the primary validation goal remains the same: to verify that system components and functions are correct to specification. A strong and detailed validation approach is critical toward achieving success in process control system qualification; verification of individual I/O channel configuration through automated sequences must be precise and thorough. As in any qualification, having clear and concise documentation is of critical importance. 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 Process Control 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 process control system qualification needs.

 

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