Glossary
Manufacturing Operations Management Systems (MOMS)
What are Manufacturing Operations Management Systems (MOMS) in pharma?
Manufacturing operations management systems (MOMS) in the pharmaceutical industry are integrated software solutions designed to manage and optimize all manufacturing operations. These systems provide a comprehensive framework for overseeing the entire production process, from planning and execution to monitoring and control.
Why is MOMS important in pharma?
Manufacturing Operations Management Systems (MOMS) ensures compliance with regulatory requirements, such as FDA 21 CFR Part 11, to avoid costly fines and reputational damage. It provides real-time visibility into manufacturing operations, enabling data-driven decisions and improved product quality. MOMS automates and standardizes processes, reducing errors and variability and increasing efficiency.
It enables track-and-trace capabilities, ensuring the authenticity and integrity of pharmaceutical products. Manufacturing operations management systems facilitates continuous improvement and optimization of manufacturing processes, reducing costs and increasing productivity. By integrating with other systems, MOMS provides a single source of truth for manufacturing operations, enabling better collaboration and decision-making across the organization.
What are the benefits of implementing Manufacturing Operations Management Systems (MOMS)?
Here are some key benefits of implementing Manufacturing Operations Management Systems (MOMS) in the pharmaceutical industry
- Product Quality: MOMS enables real-time monitoring and control of production processes to meet quality standards.
- Regulatory Compliance: MOMS provides comprehensive tracking and documentation of the batch manufacturing process, facelifting traceability and maintaining regulatory compliance
- Productivity and Reduced Costs: Leveraging MOMS in the pharmaceutical industry helps improve productivity, reduce costs, adapt to market demands and technological changes, and maintain compliance.
How does MOMS ensure regulatory compliance?
Manufacturing Operations Management Systems (MOMS) provides electronic batch records and audit trails to meet FDA 21 CFR Part 11 requirements. It ensures accurate and consistent product labelling and packaging to comply with GMP and FDA regulations. MOMS automates data collection and reporting to meet the EU’s Annex 11 and FDA’s CGMP guidelines. It enables real-time monitoring and control of manufacturing processes to ensure compliance with OSHA and EPA regulations. It provides role-based access control and electronic signatures to ensure accountability and data integrity. By automating and documenting manufacturing processes, MOMS helps reduce the risk of non-compliance and ensures a state of control.
