INDUSTRY
Life Sciences
In the highly regulated healthcare and life sciences industries, compliance and quality control are paramount. RTS Consulting Automation offers advanced MES solutions that help companies meet critical standards such as FDA 21 CFR Part 11, GMP, and EU Annex 11.
Compliance-Driven, Results-Oriented
RTS Consulting Automation specializes in delivering SAP MES solutions designed to meet the industry’s strict regulatory requirements while optimizing production efficiency. Our MES systems provide:
- Seamless integration with existing ERP and shop floor systems.
- Compliance with FDA 21 CFR Part 11, GxP, and GMP regulations.
- Tailored solutions that adapt to the specific needs of pharmaceutical manufacturers.
Our Impact:
- Ensure the integrity of electronic records and audit readiness.
- Maintain compliance across all stages of production.
- Achieve real-time visibility and control over critical production processes
Core Benefits
Ensuring Regulatory Compliance
Ensure compliance with FDA 21 CFR Part 11, GMP, and EU Annex 11, helping pharmaceutical manufacturers maintain data integrity, control processes, and ensure the accuracy of all records and reports
Batch Production & EBR Compliance
Efficiently manage batch production with automated electronic batch records (EBR), ensuring consistent, accurate, and compliant production documentation across the entire batch lifecycle.
Enhanced Serialization and Traceability
Protect your products with robust serialization and genealogy capabilities, ensuring complete traceability and compliance with anti-counterfeiting regulations.
Real-Time Data and Operational Efficiency
Enhance decision-making with real-time data integration, helping identify bottlenecks, reduce downtime, and optimize workflows for improved efficiency.
Key Features
FDA 21 CFR Part 11 Compliance
Streamline compliance with electronic batch records (EBR), automated data collection, and electronic signatures, ensuring seamless adherence to regulatory standards.
Batch Production Automation
Optimize batch production with precise control, consistent quality, and enhanced traceability, ensuring compliance and maintaining high production standards.
Serialization and Genealogy
Protect your products with serialization and genealogy capabilities and ensure traceability across the supply chain and safeguard product integrity.
Real-Time Data Integration
Integrate data from across your operations to improve decision-making, eliminate bottlenecks, and streamline workflows, boosting efficiency.
Our Proven Process
Assessment & Consultation: Understand your unique manufacturing challenges and goals.
Fit-to-Standard Solutions: Provide tailored MES solutions aligned with your operational requirements.
Implementation: Seamlessly integrate MES with existing systems while minimizing disruption.
Support & Optimization: Provide ongoing support and continuous improvement strategies.
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