Engineering, implementation, and maintenance support
Advance process development or speed time to market with our automation engineering expertise. Our team of engineers and project managers offers expert support for process development, proof of concept, and product development for complex medical and pharma production.
Outsource FDA approval and technical validation documentation. Our seven-step design documentation process produces all required documents, including Functional Design Specification (FDS), Hardware Design Specification (HDS), Software Design Specification (SDS), Risk Assessment (RA), SISTEMA Report (SR), Factory Acceptance Test Protocol (FAT), and Site Acceptance Test Protocol (SAT).
Define, assess, and mitigate hazard risk with more precision with performance-level risk assessment (PLr). Our process meets all requirements for independently verified assessment and documentation, including SISTEMA evaluation.
Setup, Startup & Training
Ensure success in the transition from our facility to yours. We lead setup, integration, and training on-site to help your staff understand how to run and maintain your machine, including planning to minimize disruption and maximize productivity.
Preventative & Continuous Maintenance
Assure maximum uptime, continued performance, and efficiency for your robotic and automation equipment with preventive and continuous maintenance programs. Your productivity comes first—we schedule inspections, replacements, tune-ups, and planned work around your schedule. We also offer emergency service after hours and on weekends.
Upgrades & Machine Services
Retool or upgrade an existing machine for a new SKU, product, or process. Our engineering services team supports you with consultations on changes to process, integration, and performance and leads execution and implementation.