42Q is fully GAMP 5 and Part 11 compliant
42Q, a leading provider of cloud manufacturing execution systems - or MES's - has announced that the company's products are Good Automated Manufacturing Practice (GAMP 5) and Part 11 compliant.
GAMP 5 is the current methodology established by the International Society for Pharmaceutical Engineering, and outlines the best practice approach for validations within the medical industry. 42Q’s MES solution was recently assessed for compliance with GAMP standards by Excellis Health Solutions, LLC.
Bob Eulau, CEO of 42Q, said: “42Q’s leadership in cloud-based MES is strengthened for medical product manufacturers by our confirmed compliance with GAMP 5 and Part 11. 42Q customers in the medical device, pharmaceutical and life sciences industries can be confident that their quality systems meet the latest standards for electronic device history records. The combination of cloud-based MES and Part 11 compliance accelerates manufacturers ability to rapidly implement robust solutions in a challenging regulatory environment.”
Karan Narang, Executive VP at Excellis Health Solutions, added: "We evaluated 42Q’s MES and found it to be fully compliant with GAMP 5 requirements. Moreover, we assessed 42Q operating as the MES at a large medical manufacturer, and found the performance and implementation to be robust in terms of quality management, product lifecycle management, product test and documentation management.”
Srivats Ramaswami, CTO at 42Q, concluded: “Process validation is a key part of the quality system for medical device manufacturers, and validation of manufacturing software and automated systems has become essential. Complying with regulatory requirements is important to obtain premarket approvals for new and modified medical devices."
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