Line_SpacerProcess Validations 

IMG_7413The Process Validation testing elements we manage are Facility, Equipment, Process/Product, and Software. Our process is to establish documented evidence, which to a high degree of assurance will show that a specific process will consistently produce product to its specifications and tolerances.

This is a key part of our quality plan (which is referred to as C-Quality) that helps define the ISO certifications. C-Axis is certified and operates to ISO 9001 and ISO 13485 (an internationally accepted set of standards/guidelines), which allows C-Axis to work with the original equipment manufacturers (OEMs) in a streamlined-fashion for the manufacturing of medical products and validation testing.

The general validation concept follows the laws and guidelines set forth by the US IMG_7417_0Food and Drug Administration (FDA) 21 CFR Part 820. C-Axis will create a Master Validation Plan (MVP). This tool will help communicate the overall status of the plan. Validations are documented using these three protocols IQ/OQ/PQ.