ZenQMS supports the USDM Cloud Assurance Certified program, which helps technology vendors meet the quality and compliance demands of the life sciences industry.
SANTA BARBARA, CALIFORNIA — (March 21, 2023) — ZenQMS, a leading provider of cloud-based electronic quality-management system (eQMS) software, has partnered with USDM Life Sciences (USDM), a premier technology consulting firm focused on cloud-based regulatory compliance, to make it easier for life sciences clients to qualify and maintain implementations of the ZenQMS platform in accordance with U.S. Food and Drug Administration (FDA) and global regulatory standards.
“We have always believed that supporting life sciences companies with critical software like an eQMS means taking quality as seriously as our most conservative clients,” said ZenQMS CEO Panos Boudouvas. “That’s why ZenQMS has been proactive in its pursuit of security and GMP certifications, including ISO 9001/27001 and SOC 2 Type II. Companies should have a simple pathway to onboarding, qualifying, and implementing our software. For too long, quality teams have been afraid of what they don’t know when auditing and qualifying a cloud-based software like ours, but USDM Cloud Assurance Certification adheres to the high compliance standards required for GxP environments. That means our clients can focus on an economical, risk-based approach to qualification and spend more time on their business.”
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
April 20, 2023 | 11:00 AM PT | 2:00 PM ET
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. You can learn more about our partnership with ZenQMS here. You can find our press release about our partnership here.
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