IQ, OQ, PQ, MQ

Featured Product from FOBA Laser Marking + Engraving (ALLTEC Angewandte Laserlicht Technologie GmbH)

IQ, OQ, PQ, MQ-Image

Global standard for the process validation is FDA’s (Food and Drug Administration) “Current Good Manufacturing Practices” (CGMPs) guideline. For FDA compliant validation of the production process, following this guideline, our laser marking systems and machines pass through the required Equipment Qualification (EQ) in 4 steps (DQ, IQ, OQ, PQ/MQ). After the medical device manufacturer has finished the Design Qualification (DQ), decided for a laser marking system and prepared the specification sheet, we support the following qualification steps (IQ, OQ, PQ/MQ) for the laser marking machines delivered by us. Thus, we bring the know-how about the machines to the customer’s process in order to address a time efficient qualification, perfect adjustment and long-term process reliability. The IQ/OQ service is a proven standardized process addressing all critical aspects of the machine installation and functionality. The PQ/MQ service provides support for a stable, reliable marking process.