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."
Follow @ManufacturingGL and @NellWalkerMG
IMF: Variants Can Still Hurt Manufacturing Recovery
After a year of on-and-off manufacturing in the US, UK, and the eurozone, demand for goods surged early last week. Factories set growth records in April and May, suppliers started to recover, and US crude hit its highest price point since pre-COVID. As vaccination efforts immunise much of the US and UK populations, manufacturers are now able to fully ramp up their supply chains. In fact, GDP growth could approach double-digits by 2022.
Now, the ISM productivity measure has surpassed the 50-point mark that separates industry expansion from contraction. Since U.S. president Biden passed his US$1.9tn stimulus package and the UK purchasing managers index (PMI) increased to 65.6, both sides of the Atlantic are facing a much-welcomed manufacturing recovery.
Lingering Concerns Over COVID
Even as Spain, France, Italy, and Germany race to catch up, and mining companies pushed the FTSE 100 index of list shares to a monthly high of 7,129, some say that UK and US markets still suffer from a lack of confidence in raw material supplies. Yes, the Dow Jones has made up its 19,173-point crash of March 2020, and MSCI’s global stock index is at an all-time high.
Yet manufacturers around the world realise that these wins will be short-lived until pandemic supply chain bottlenecks are solved. If we keep the status quo, consumers will pay the price. In April, inflation in Germany reached 2.4%, and across the EU’s 19 member countries, overall prices have increased at an unusual pace. Some ask: Is this true recovery?
IMF: Current Boom Could Falter
Even as Elon Musk tweeted about chip shortages forcing Tesla to raise its prices, UK mining demand skyrocketed; housing markets lifted; and the pound sterling gained value. The International Monetary Fund (IMF), however, cautioned that manufacturing recovery won’t last long if COVID mutates into forms our vaccinations can’t touch. Kristalina Georgieva, Washington’s IMF director, noted that fewer than 1% of African citizens have been vaccinated: “Worldwide access to vaccines offers the best hope for stopping the coronavirus pandemic, saving lives, and securing a broad-based economic recovery”.
Across the globe, manufacturing companies are keeping a watchful eye on new developments in the spread of COVID. Though US FDA officials don’t think we’ll have to “start at square one” with new vaccines, the March 2021 World Economic Outlook states that “high uncertainty” surrounds the projected 6% global growth. Continued manufacturing success will in large part depend on “the path of the pandemic, the effectiveness of policy support, and the evolution of financial conditions”.
Mathias Cormann, secretary-general of the Organisation for Economic Co-Operation and Development (OECD) concurred—without global immunisation, the estimated economic boom expected by 2025 could go kaput. “We need to...pursue an all-out effort to reach the entire world population”, Australia’s finance minister added. US$50bn to end COVID across the world, they imply, is a small investment to restart our economies.