Monitoring Systems and Validation
Prokontrol offers package solutions in the pharmaceutical industry by combining project management, design and application, material supply, cGMP conformity services, validation and documentation services.
The field instrument used in the monitoring systems (sensors etc.) must be appropriate to the process. Selection of field instrument made meticulously by considering criteria like accuracy, measurement range, ease of calibration, proper installation etc. with the help of our experience.
Layers such as field instrument, field stations (DDCs) and monitoring software are provided from leading manufacturers in pharmaceutical applications around the world. Thus, systems with a structure suitable for hardware and software validation can be established.
Solutions for pharmaceutical production and storage facilities:
This includes monitoring, recording parameters that are important by quality assurance departments in terms of domestic and international standards and methods, such as Temperature, Static Pressure, Absolute Humidity, Relative Humidity, Dew Point Temperature, Mean Kinetic Temperature (MKT) and providing them to the owner together with warning and analysis / reporting functions. Monitorng and recording these parameters are compatible with FDA 21 CFR Part 11 regulations: commissioning and validation of system is compatible with GEP ve GAMP 5.0 directives.
Some applications we provide of Validated Monitoring, Recording and Management Systems:
• Control, Monitoring of HVAC Systems
• Warehouse Monitoring Systems
• Stability Chamber Monitoring
• Cold Room, Refrigerator and Deep Freezer Monitoring
• Laboratory Monitoring Systems
• Solvent Storage Monitoring Systems (Ex-Proof and Instrically Safe Instrument Applications)
• Oven, Autoclave, Incubator Monitoring System
• Clean Room Monitoring Systems
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