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

Testimonials

“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
Call Us Now +1 303.828.0844
Our Company Golden, CO 80402, USA