InduSoft Web Studio has played a major role in the Pharmaceutical industry in everything from food and drug packaging and storage, to pharmaceutical manufacturing that must adhere to strict guidelines, such as the FDA 21 CFR Part 11 and EU Annex 11 standards. InduSoft Web Studio has passed major audits from top pharmaceutical companies, and can provide the tools to create a compliance-ready SCADA software solution for the pharmaceutical industry.
GAMP, FDA 21 CFR Part 11, and EU Annex 11 Compliance
InduSoft Web Studio has all the tools required to make a project that adheres to FDA 21 CFR Part 11, EU Annex 11 and GAMP (Good Automated Manufacturing Practice) guidelines. Functionality such as security, e-signatures and traceability, batch reporting and automatic writing to any SQL database are some of the tools that can be employed to maintain a fully compliant process that will meet international standards for food and drug and pharmaceutical manufacturing. The ability to store and record data for each batch makes it easy for representatives of the FDA and EU Annex to audit and verify data.
InduSoft Web Studio Database Connectivity
InduSoft holds a patent on the ability to connect to any SQL database from embedded Windows operating systems. InduSoft Web Studio has powerful database connectivity features, making it easy to meet the stringent logging requirements necessary in the pharmaceutical industry. Databases can be easily configured for redundancy and store-and-forward configurations ensuring that critical data requirements are met.
Built-in Recipe Functionality
Facilitate easy product changeover with the built-in recipe functionality of the InduSoft Web Studio SCADA software platform. Virtually eliminate human error by enabling the necessary checks using barcode scanning, 2D matrix and RFID data collection. Integrate seamlessly with vision systems to ensure the right product is in its appropriate packaging.
Proper Warehousing Conditions Easy to Monitor
With a full SCADA solution developed on the InduSoft Web Studio platform, it’s easy to monitor and verify warehouse conditions such as air quality, temperature, and humidity. Provide accurate data for storage conditions by utilizing InduSoft’s ability to connect to virtually any device, from temperature controllers to HVAC and filtration systems.
Run InduSoft Web Studio on any Windows PC, including the NEMA 4x, IP65 and stainless steel mounted PCs that provide a sterile and safe surface in pharmaceutical manufacturing. For more information on the types of panel PCs available with InduSoft Web Studio’s SCADA software already installed, please see our list of certified hardware manufacturers.
From individual machine or material handling HMI to large scale supervisory stations InduSoft Web Studio SCADA HMI software offers everything required for a powerful solution.
IWS tools for FDA 21 CFR Part 11