QAD Inc., a leading provider of next-generation manufacturing and supply chain solutions in the cloud, will join the exclusive USDM Life Sciences Cloud Assurance Certification program. After a formal audit and review of QAD SOPs and SDLC business processes, USDM Life Sciences has also released the QAD Cloud Assurance Report.
This third party assessment provides QAD life sciences customers with documented evidence of the rigorous and well-tested development, quality, security, cloud hosting, and training processes and policies supporting Life Sciences GMP requirements. The report can also be leveraged during internal and external audits, saving manufacturers and their suppliers considerable time and resources. Instead of wasting effort reviewing checklists, requesting input from the various stakeholders, and chasing down documented procedures, quality and regulatory personnel can easily reference the QAD Cloud Assurance Report in their audit documentation and focus their time on more critical, value-added company activities.
“There’s never been a more important time to deliver life-sustaining and life-changing vaccines, treatments and cures to people around the world,” said Jennifer Petrosky, director, life sciences at QAD. “Leveraging digital technologies, including QAD digital manufacturing and supply chain applications in the cloud, is a critical way to keep life sciences companies focused on what they do best, delivering innovation.”
Regardless of the application, life sciences companies have been reluctant to adopt cloud-based applications for multiple reasons. First and foremost is the fear of non-compliance. Both FDA and European Commission data management systems regulations FDA 21 CFR 11.10 (a) and EudraLex Annex 11 Section 4 require computer system validation (CSV) to be performed across the entire lifecycle of computer systems used for the manufacturing, storage, or testing of a drug or medical device product. Failure to maintain a validated state for any computer system could result in regulatory citation, fines or even product recalls. Historically, this has been a long and arduous task. Now with QAD partnering with USDM, customers can circumvent these costs, risks and delays by engaging with technology leaders armed with a world-class validation platform as part of a global ERP deployment.
“USDM manages continuous cloud compliance for hundreds of life sciences customers, and we understand their reluctance to adopt cloud technologies first-hand,” said Kim Hutchings, head of alliances at USDM Life Sciences. “As trusted thought leaders, we believe it’s our duty to help life sciences companies turn regulation into innovation and utilize modern applications like QAD to get their products, therapies and devices to market faster.”
Having access to adaptive digital solutions on a frequent and periodic basis allows life sciences companies to stay competitive and deliver products to patients in new markets more quickly, reduce the cost of compliance and minimize the risk of regulatory penalties. QAD customers that join this program will be on a path for continuous software upgrades when they need it, achieve a state of continuous compliance, and save considerable resources along the way.
To learn more about QAD Cloud Assurance, please visit the USDM website.
About QAD – Enabling the Adaptive Manufacturing Enterprise
QAD Inc. is a leading provider of next-generation manufacturing and supply chain solutions in the cloud. Global manufacturers face ever-increasing disruption caused by technology-driven innovation and changing consumer preferences. In order to survive and thrive, manufacturers must be able to innovate and change business models at unprecedented rates of speed. QAD calls these companies Adaptive Manufacturing Enterprises. QAD solutions help customers in the automotive, life sciences, consumer products, food and beverage, high tech and industrial manufacturing industries rapidly adapt to change and innovate for competitive advantage.
Founded in 1979 and headquartered in Santa Barbara, California, QAD has 30 offices globally. Over 2,000 manufacturing companies have deployed QAD solutions including enterprise resource planning (ERP), digital supply chain planning (DSCP), global trade and transportation execution (GTTE) and enterprise quality management system (EQMS) to become an Adaptive Manufacturing Enterprise. To learn more, visit www.qad.com or call +1 805-566-6100. Find us on Twitter, LinkedIn, Facebook, Instagram and Pinterest.
“QAD” is a registered trademark of QAD Inc. All other products or company names herein may be trademarks of their respective owners.
About USDM Life Sciences
At USDM Life Sciences, our purpose is to bring clarity and action to the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. We help our customers use cutting-edge technology to increase their speed to market while ensuring continuous compliance and patient safety. For more information, visit www.usdm.com.
For more information on USDM’s Cloud Assurance program or if you are a technology provider interested in becoming certified, you can learn more here.