Proven Solution for Highly Regulated Industries
42Q is highly configurable and is a superior MES Solution for a broad range of industries and different types of manufacturing.
42Q has been refined over the past 15 years to exceed the regulatory, audit and agency requirements for quality records, software validations and process controls for highly regulated industries. Our software validations ensure accuracy, reliability, and consistent standards for all products produced using 42Q. The result is confidence when providing records for regulatory audits, especially for production implementations with hundreds of top level assemblies and complex bills of material.
Ensure regulatory requirements for 21 CFR Part 11 are enforced across all manufacturing operations with complete electronic Device History Records and Electronic Signatures. 42Q helps Medical Device manufacturers reduce compliance costs by replacing paper-based systems with streamlined processes that improve flexibility for changing market conditions. Traceability features track genealogy at a highly granular level which is essential for total compliance. Plus, with the integration of training systems, workstations can instantly lockout any operator who is not certified on the latest revisions of work instructions. 42Q is certified for GAMP5 compliance.
Automotive manufacturers face a challenging regulatory landscape and increasing production and supply chain discipline. 42Q delivers visibility and control across manufacturing operations and supply chains. 42Q is TS16949 compliant and provides confidence based on years of automotive production in over a dozen automotive manufacturing locations. Complete product and process traceability, enterprise-wide enforcement and visibility results in predictable quality, and higher customer satisfaction.
When it comes to manufacturing sophisticated aerospace equipment, there is no margin for error. 42Q helps mitigate risk by enforcing regulatory compliance and reporting requirements including AS9100. Manufacturers in the Aerospace & Defense industry need a solution that will deliver extensive component and process genealogy and earned value management.