PharmaSuite from Rockwell Software is an advanced MES designed for the pharmaceutical industry. It provides an integrated solution to manage and optimize production processes, ensuring compliance with industry standards and regulations. PharmaSuite streamlines manufacturing operations, enhances production efficiency, and ensures product quality and consistency.
PharmaSuite Key Features:
- Goods Manufacturing Practice (GMP) Life Cycle Management: Offers comprehensive management of the GMP life cycle, ensuring that products are consistently produced and controlled according to quality standards.
- Master Recipe Maintenance: Facilitates the creation, management, and storage of master recipes, providing a centralized system for recipe information and revision control.
- 21 CFR Part 11 Regulatory Compliance: Ensures compliance with the FDA’s 21 CFR Part 11 regulation, which sets criteria for electronic records and electronic signatures, vital for the pharmaceutical industry.
- Batch Record Generation: Automates the generation of batch records, improving accuracy and efficiency while reducing the potential for human error.
- Integration with ERP Systems: Seamlessly integrates with Enterprise Resource Planning (ERP) systems, facilitating better coordination between manufacturing and business operations.
PharamSuite Benefits:
- Enhanced Compliance: Assists in meeting regulatory requirements, reducing the risk of non-compliance and associated costs.
- Increased Efficiency: Streamlines manufacturing processes, reducing waste and increasing throughput.
- Improved Product Quality: Ensures consistent product quality, enhancing customer satisfaction and trust.