42Q Announces GAMP 5 and Part 11 Compliance
for Cloud-Based Manufacturing Execution System
San Jose, Calif., July 12, 2016 – 42Q, a leading provider of cloud manufacturing execution systems (MES), today 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 (ISPE) and sets forth 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.
42Q delivers a comprehensive and proven cloud MES solution, with unique on-demand pricing that eliminates capital expenditure and other upfront costs. 42Q has been used as the MES core for many years in medical manufacturing facilities producing both high volume medical devices, along with highly complex diagnostic imaging equipment. Today, 42Q is deployed in twenty medical manufacturing facilities having International Organization for Standardization (ISO) 13485 certification, and eight facilities having Food and Drug Administration (FDA) registration for Class 1, 2 or 3 medical products.
During a FDA audit, the ability to produce correct, clear and verifiable quality records in a timely manner is essential. GAMP 5 represents a general medical industry alignment regarding the use of a risk-based approach to qualification and validation for automated systems and new equipment. Compared with previous versions, GAMP 5 provides additional focus on risk control and quality management. Validation efforts must be independent of other product risk assessments and instead investigate the impact of automation and software systems on patient safety, product quality and data integrity.
“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,” said Bob Eulau, CEO of 42Q. “The combination of Cloud-Based MES and Part 11 compliance accelerates manufacturers ability to rapidly implement robust solutions in a challenging regulatory environment.”
In March 2016, a GAMP assessment was conducted by Excellis Health Solutions to determine the compliance of 42Q’s cloud MES with GAMP 5 methodology. “We evaluated 42Q’s MES and found it to be fully compliant with GAMP 5 requirements”, said Karan Narang, executive vice president at Excellis Health Solutions. “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.”
“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,” said Srivats Ramaswami, CTO at 42Q.