Quality Agents, LLC.
Quality Agents, LLC. specializes in providing comprehensive quality assurance, quality control, validation, and project management services primarily for the pharmaceutical, biotechnology, and medical device industries. They support clients with operational needs, offering expert consulting, validation, and testing services to ensure compliance and operational excellence. With over 10 years of experience, they focus on building strong relationships, maintaining compliance standards, and delivering cost-effective solutions. Their leadership team includes Carla Rampy (CEO), Emily Ridgely (Sr. Director of Quality Assurance Services), Joelle Thomas (HR and Finance), Julio Franco (Director of Technical Services), Amit Jain (Director of Operational Services Maryland), and Shafile Rashid (Director of Validation Services). They actively support their clients through a range of services, including validation, quality assurance, quality control, project management, and environmental monitoring equipment rental.
Industries
Nr. of Employees
small (1-50)
Quality Agents, LLC.
Wilmington, North Carolina, United States
Products
Temperature validation system (wired console-based)
Integrated wired temperature-validation platform for multi-sensor studies offering study setup, automated calibration, data logging, merging, graphing and compliant reporting for sterilizer and controlled-environment validations.
Cryogenic-range temperature data logger
Flexible-tip temperature data logger rated for extended ranges (approximately −85 °C to +140 °C) suitable for cryogenic chambers, lyophilizers, ultralow freezers and sterilization cycles; designed for on-site user verification and long battery life.
Portable dry-well calibration baths (wide/ultra-low range)
Dry-well calibration baths for fixed-point or range-based temperature calibration and sensor verification, including units designed for ultra-low temperatures (down to ~−90 °C) with fast response and software interfaces for automated calibration.
Temperature and humidity data loggers and wireless humidity loggers
Portable data loggers for temperature and humidity monitoring including options for cryogenic ranges and wireless/higher-memory humidity loggers for stability and storage validation.
Humidity and dew-point probes with multi-logger reader interfaces
Humidity and dew-point measurement probes with reader interfaces for programming and data collection from multiple loggers and integration with calibration workflows.
Air sampling instrumentation (viable and non-viable particle counters)
Air sampling instruments for microbial detection and non-viable particle counting for environmental monitoring and regulatory compliance; includes devices with onboard SOP guidance, electronic approval and networked export.
Temperature validation system (wired console-based)
Integrated wired temperature-validation platform for multi-sensor studies offering study setup, automated calibration, data logging, merging, graphing and compliant reporting for sterilizer and controlled-environment validations.
Cryogenic-range temperature data logger
Flexible-tip temperature data logger rated for extended ranges (approximately −85 °C to +140 °C) suitable for cryogenic chambers, lyophilizers, ultralow freezers and sterilization cycles; designed for on-site user verification and long battery life.
Portable dry-well calibration baths (wide/ultra-low range)
Dry-well calibration baths for fixed-point or range-based temperature calibration and sensor verification, including units designed for ultra-low temperatures (down to ~−90 °C) with fast response and software interfaces for automated calibration.
Temperature and humidity data loggers and wireless humidity loggers
Portable data loggers for temperature and humidity monitoring including options for cryogenic ranges and wireless/higher-memory humidity loggers for stability and storage validation.
Humidity and dew-point probes with multi-logger reader interfaces
Humidity and dew-point measurement probes with reader interfaces for programming and data collection from multiple loggers and integration with calibration workflows.
Air sampling instrumentation (viable and non-viable particle counters)
Air sampling instruments for microbial detection and non-viable particle counting for environmental monitoring and regulatory compliance; includes devices with onboard SOP guidance, electronic approval and networked export.
Services
End-to-end validation support including protocol development, execution, calibration, and maintenance of validated state for GxP equipment and processes.
QA program advisory services and mock audit execution to prepare organizations for regulatory inspections and to maintain GxP compliance.
Support for laboratory QC activities and analytical methods used to maintain process control and compliance.
Comprehensive project and program management services from initiation through closure for technical and compliance projects.
Short- and long-term rental of measurement, test and validation instruments with pre-rental servicing, traceable recalibration and shipping logistics; online reservation and fleet scheduling support.
Onsite environmental monitoring support including microbial air sampling and non-viable particle counting for controlled environments, with electronic reporting options.
End-to-end validation support including protocol development, execution, calibration, and maintenance of validated state for GxP equipment and processes.
QA program advisory services and mock audit execution to prepare organizations for regulatory inspections and to maintain GxP compliance.
Support for laboratory QC activities and analytical methods used to maintain process control and compliance.
Comprehensive project and program management services from initiation through closure for technical and compliance projects.
Short- and long-term rental of measurement, test and validation instruments with pre-rental servicing, traceable recalibration and shipping logistics; online reservation and fleet scheduling support.
Onsite environmental monitoring support including microbial air sampling and non-viable particle counting for controlled environments, with electronic reporting options.
Expertise Areas
- Validation and commissioning for GxP environments
- Quality assurance program implementation and audit readiness
- Laboratory quality control and analytical testing
- Environmental monitoring and cleanroom testing
Key Technologies
- Wired temperature validation systems with console-based data handling
- Temperature and humidity data loggers (including cryogenic-range)
- Dry-well calibration baths (portable, −90 °C to +140 °C ranges)
- Traceable RTD temperature probes and calibration standards