Process 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.

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.

Masy BioServices can support the validation of your process control system, from providing review of the installation phase documentation through generating the required project documents and executing the qualification protocols.

Contact Masy BioServices today for your process control system qualification needs.

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