IngenioRx
Engineering and validation consulting firm serving the medical device and life sciences industries. Offers validation planning and execution, quality systems support, supplier integration, project management, and process-transfer/continuous improvement services. Operates in North America, South America and the Asia Pacific with offices in El Paso, TX and Ciudad Juárez, Chihuahua.
Industries
Nr. of Employees
small (1-50)
Products
Process & Product Transfers
Project management services focused on process and product transfers.
Continuous Improvement Projects
Project management services for continuous improvement initiatives.
Process & Product Transfers
Project management services focused on process and product transfers.
Continuous Improvement Projects
Project management services for continuous improvement initiatives.
Services
Consulting services for validation strategy, process/product characterization, IQ/OQ/PQ, software validation, packaging qualification, test method validation, supplier integrations, and sterilization configuration.
Support for CAPA, document control, bilingual translation of quality documentation, quality engineering, and tailored quality compliance activities.
Resource planning and project execution services for engineering, validation, process transfers, and continuous improvement initiatives.
Consulting services for validation strategy, process/product characterization, IQ/OQ/PQ, software validation, packaging qualification, test method validation, supplier integrations, and sterilization configuration.
Support for CAPA, document control, bilingual translation of quality documentation, quality engineering, and tailored quality compliance activities.
Resource planning and project execution services for engineering, validation, process transfers, and continuous improvement initiatives.
Expertise Areas
- Medical device validation
- Quality systems implementation and compliance
- Supplier quality management
- Packaging and sterilization validation
Key Technologies
- IQ/OQ/PQ qualification protocols
- Test method (analytical) validation
- Sterilization validation and load configuration
- Computer software validation protocols