ZenQMS

2023年3月21日

分享这篇文章提供的新闻分享这篇文章ZenQMS支持USDM云保证认证计划,这有助于技术供应商满足质量和生命科学产业的合规要求。加州圣芭芭拉分校,2023年3月21日ZenQMS,从基于云计算的电子质量管理系统的领先供应商(秦岭)软件,已经与USDM生命科学(USDM)总理技术咨询公司专注于基于云的法规遵从性,使它更容易为生命科学的客户的资格和维护实现ZenQMS平台按照美国食品和药物管理局(FDA)和全球监管标准。“我们一直相信,支持关键软件的生命科学公司像一个秦岭意味着重视质量作为我们最保守的客户,“说ZenQMS首席执行官帕诺斯Boudouvas。“这就是为什么ZenQMS一直在积极的追求安全和GMP认证,包括ISO 9001/27001和SOC 2 II型。公司应该有一个简单的途径来新员工培训,资格,实现我们的软件。长久以来,质量团队一直害怕他们不知道什么时候审计和排位赛我们这样的基于云计算的软件,但是USDM云保证认证坚持GxP所需的高合规标准环境。这意味着我们的客户可以专注于一个经济,基于风险的方法来评定和花更多的时间在他们的业务。”USDM's Cloud Assurance Certification confirms that Software as a Service (SaaS) vendors have passed a comprehensive assessment and met the quality and compliance demands of the industry. It is the badge of trust for GxP functionality. The USDM Cloud Assurance Certified program ensures that cloud technology is implemented, validated, and maintained in a compliant state, satisfying more than 30 worldwide health authorities' nonfunctional requirements, and supporting functional requirements, as defined in over 6,500 regulatory requirements. "The life sciences industry has been embracing the opportunities provided by digital transformation at an accelerated rate. One example of this is a growing demand for cloud technology. To help the sector reap the benefits offered by these innovations, USDM created Cloud Assurance Certified to distinguish GxP-ready solutions." said John Petrakis, Vice President of Cloud Assurance at USDM. "We are committed to partnering with forward-thinking technology companies around the world, and ZenQMS is one of them. This project demonstrated their dedication to helping customers quickly and easily deploy GxP-enabled cloud services." Said Mr. Boudouvas, "We think Cloud Assurance Certification does for GxP regulatory compliance what standards like ISO 27001 and SOC 2 Type II do for data security, and we are grateful for USDM's leadership on this matter." Karin Ashkenazi, Vice President of Quality Assurance at ZenQMS, added, "We host more than a hundred qualification and routine client audits per year, and I found USDM's audit of ZenQMS to be thorough. More importantly, the published report is easy for customers to understand and leverage." ZenQMS supports the life sciences community with a unique approach to quality management organized around a platform that is easy to acquire, implement, validate, and use. They help hundreds of innovators and GxP vendors and contractors around the transition to qualified cloud services. To learn more about ZenQMS and USDM's partnership, register for their upcoming webinar. Simplify GxP Quality Assurance About ZenQMS Headquartered in suburban Philadelphia, ZenQMS is a 100% cloud-native application helping life sciences companies that want an easy-to-use, affordable way to maintain compliance with GxP and ISO requirements. ZenQMS offers a unique approach to client engagement and pricing, including turnkey implementation, personalized onboarding, and a customer-friendly annual fee that includes access to the whole platform that scales as clients grow. The software is 21 CFR Part 11 and Annex 11 compliant and offers simple and versatile configuration options to meet a client's unique needs. In-house support is included at no additional cost; customers don't need an IT team or a large QA team to purchase, implement, or manage ZenQMS. Learn more at www.zenqms.com . 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 . Media Contact: