The robust Quality Management System (QMS) adopted by Inzign integrates all departments, standardising all documents as well as ensuring all operations in Inzign are well-documented. This promotes good communication between departments with its policies, processes and procedures, improving Inzign’s ability to meet customer requirements.

All operations in Inzign are register to ISO 13485 and is in full compliance with cGMP. The quality team within Inzign, that has a rich understanding of global regulatory and industry trends, upholds these standards with mature systems which are rigorously audited and calibrated to industry standards.

Process Validation

Inzign employs a process validation to systematically collect and evaluate data from all production processes to determine its capability in delivering great quality product consistently. The process validation is broken up into 3 distinctive protocols; Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

These three protocols are strictly adhered to in Inzign and allows for all aspects of both the product and its production to be assessed in detail. Failure in meeting requirements set in these protocols prevents the product or its production from receiving the necessary qualifications. The production is reassessed, corrected and goes through the process validation again. Only products and its production that have met the requirements set in all three protocols are approved and delivered to customers.

IQ

Installation Qualification

entails the verification that the tool installation is up to standard.

OQ

Operational Qualification

entails the verification required for the acceptance of molding tool operations.

PQ

Performance Qualification

entails the verification and validation of both the product requirements and acceptance criteria, in order to assess the mold tool performance.