The 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 Food 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.