Rockwell Automation , the world’s largest company dedicated to industrial automation and digital, has successfully partnered with NKP Pharma, a leading manufacturer of pharmaceutical packaging machinery, to implement an advanced visualization solution that enhances regulatory compliance and data accessibility in pharmaceutical manufacturing. By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11 while reducing operational costs and enhancing customer experience.
In the past, NKP Pharma had faced challenges in meeting stringent industry regulations, particularly USFDA 21 CFR Part 11, which governs electronic records and signatures to ensure data integrity and traceability.
Commenting about this key achievement, Alpesh Mistry, Vice President of Operations, NKP Pharma, said: “I can proudly say that after implementing FactoryTalk Optix, we now have a cost-effective solution that meets the market’s regulatory needs without the high costs of IPC-SCADA.”
Traditional IPC-SCADA systems had become cost-prohibitive and restricted direct data access for customers, limiting operational efficiency and satisfaction. To address these challenges, NKP Pharma sought a cost-effective, scalable, and compliant solution that would allow greater control over operational data while delivering adherence to regulatory requirements.
Speaking about the partnership with NKP Pharma, Dilip Sawhney, Managing Director, Rockwell Automation India said: “NKP’s achievement in compliance is truly impressive, and we are thrilled about it. Our collaboration with NKP Pharma demonstrates how advanced visualization and real-time data accessibility can help enhance compliance, innovate, and reduce operational costs.”
“By equipping manufacturers with cutting-edge automation technologies, we help them meet global regulatory standards, improve efficiency, and strengthen their competitive edge in a rapidly evolving industry,” added Dilip.
FactoryTalk Optix is a next-generation HMI (Human-Machine Interface) platform designed for advanced visualization, real-time insights, and seamless data integration. The key benefits included enhanced compliance with regulations like 21 CFR Part 11 through user-level access control, audit trails, and electronic records; cost-effective implementation, reducing the high costs associated with traditional IPC-SCADA systems; and increased operational efficiency by providing real-time data access to customers, improving decision-making and machine performance.
