Production and Process Control
Process controls are one of the four primary subsystems targeted by FDA inspectors applying FDA’s Quality System Inspection Technique (QSIT), and are also a primary focal point in ISO 13485 audits.
ComplianceAcuity has experience in a broad range of manufacturing environments, including but not limited to, sterile and non-sterile products, cardiac, point-of-care, dental, bone-void-fillers, orthopedic implants, ophthalmic, electrosurgical, vital signs monitoring, and in vitro diagnostic products, to name some.
We can provide valuable insight to your process control efforts by offering best-practices solutions for:
- User-friendly procedures and templates for process validation and software validation
- Equipment Maintenance/Calibration
- Change control
- Environmental control
- Facility maintenance
“Kevin’s work style was logical and well-thought-out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way”
- President & Founder, Class II Devices