May 16, 2020

42Q is fully GAMP 5 and Part 11 compliant

42Q
MES
GAMP 5
Part 11
Nell Walker
2 min
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 areGood Automated Manufa...

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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May 10, 2021

Lion Electric to Construct US EV Manufacturing Facility

ElectricVehicles
SmartManufacturing
Sustainability
Technology
Georgia Wilson
3 min
Lion Electric |Smart Manufacturing | Sustainable Manufacturing | Electric Vehicles | Electric School Buses | Electric Medium and Heavy Duty Vehicles | Sustainability | Technology | Freight | Transportation
Lion Electric announces its selection of Illinois to construct its all-electric medium and heavy-duty urban vehicle manufacturing facility...

Who is Lion Electric?

Founded in 2008, Lion Electric is an innovative manufacturer of all-electric, zero-emissions, medium and heavy-duty urban vehicles. Lion Electric designs, manufactures, and assembles all components for its vehicles that have unique features specifically adapted to the users and their needs. “We believe that transitioning to all-electric vehicles will lead to major improvements in our society, environment and overall quality of life,” believes Lion Electric. 

Lion Electric’s new Illinois Manufacturing Facility

Just two months after announcing plans to construct a battery manufacturing plant and innovation centre in Quebec, Lion Electric is expanding its locations further, selecting Joliet, Illinois for its new manufacturing facility in the US.

The new facility is said to “represent the largest dedicated production site for zero-emission medium and heavy-duty vehicles in the US,” as well as being the company’s biggest footprint in the market. The new facility will give Lion Electric the capacity to meet increasing demand for ‘Made in America’ zero-emission vehicles and bring production closer to customers. 

It is expected that the first vehicles off the production line will be in the second half of 2022.

“Lion’s historic investment to bring its largest production facility to Illinois represents not only a win for our communities, but a strong step forward in our work to expand clean energy alternatives and the jobs they bring to our communities,” said Gov. J.B. Pritzker. 

“The new Joliet facility will put Illinois at the forefront of a national movement to transition to zero-emission vehicle use, advancing our own goals of putting one million of these cars on the road by 2030. In Illinois, we know that a clean energy economy is about more than just vehicles – it’s about healthier communities and jobs for those who live there. We are excited to welcome Lion to the Land of Lincoln and look forward to their future success here.”

Lion Electric’s Agreement with the Government of Illinois

Over the next three years, Lion Electric will invest a minimum of US$70mn into Illinois. The new facility - totalling 900,000 square feet - is expected to create a minimum of 745 clean energy direct jobs in the next three years, and have an annual production capacity of up to 20,000 all electric buses and trucks.

Scaling electric bus production and decarbonising freight and transportation

As the US moves to electrifying its school buses, the additional production capacity at the facility will help Lion Electric to scale its electric bus production, as well as produce an increased volume of heavy-duty zero-emission trucks to help governments and operators in the US further the decarbonisation of freight and transportation fleets.

“Lion is the leader in electric school buses and has always been dedicated to the U.S. market, and our commitment to be close to our customers is one of the core values we have as a company. This significant expansion into the U.S. market will not only allow us to drastically increase our overall manufacturing capacity of electric trucks and buses but to also better serve our customers, while adding critical clean manufacturing jobs that will form the backbone of the green economy,” said Marc Bedard, CEO and Founder of Lion.

“I also want to acknowledge the crucial role that P33 and Intersect Illinois, civic groups committed to developing developing a long-term roadmap for the local tech industry, played in connecting Lion with the Chicago area’s business and civic community to help further commercial traction, as well as engagement with key workforce and supplier partners.” 

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