The Certification offers PTC Vuforia customers audit-ready documents to leverage as regulatory evidence and frees their resources to focus on innovating.
SANTA BARBARA, CALIFORNIA — (August 8th, 2023) – USDM Life Sciences, a premier technology consulting firm focused on regulatory compliance, is announcing that PTC’s Vuforia Expert Capture, an easy-to-use SaaS Augmented Reality (AR) solution designed to make frontline work more efficient, has successfully completed its Cloud Assurance Certification Program. This means the company underwent a rigorous assessment and remediation to meet thousands of global regulatory requirements. As a result of the Cloud Assurance alliance, PTC Vuforia customers won’t need to run their own validation tests, which will save them time and money and lessen their validation burden. This creates a win-win situation for everyone involved: PTC’s customers can concentrate on using AR technology, PTC can develop breakthrough software, and USDM can take care of automating and optimizing validation while ensuring compliance.
Currently, there is no industry-set standard or certification for GxP compliance, which is why USDM stepped in and developed its Cloud Assurance Certification program. This certification provides life science companies with audit-ready documentation, including a Vendor Assurance Report and a Vendor Audit, to use as regulatory evidence.
When conducting the assessment, USDM uses its proprietary USDM Compliance Matrix, an automated tool that identifies relevant global regulations for life science customers. These include the U.S. Food and Drug Administration 21 CFR Part 11 and predicate rules, the European Union Annex 11, General Data Protection Regulation, Health Canada, the Australian Government Department of Health Therapeutic Goods Administration, and thousands of other global regulations.
“This is a significant milestone for us as we continue to establish USDM as a trusted advisor for global life science companies and Cloud Assurance Certification becomes the industry’s gold standard,” said John Petrakis, vice president of Cloud Assurance, USDM Life Sciences. “PTC is a renowned provider of innovative solutions for the pharmaceuticals industry, and we are honored to support them on their compliance journey. Obtaining Cloud Assurance Certification will allow them to focus on providing their customers with cutting-edge software and not worry about investing additional time and money into validation.”
“With the Cloud Assurance Certification, we make it easier for our customers to leverage AR solutions in regulated markets. Audit-ready documentation from USDM helps life sciences companies to use validated procedures from our Expert Capture SaaS solution,” said JJ Lechleiter, General Manager of Vuforia at PTC.
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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 utilize cutting-edge technology to increase their speed to market while ensuring continuous compliance and patient safety. For more information, visit www.usdm.com.
PTC enables global manufacturers to realize double-digit impact with software solutions that enable them to accelerate product and service innovation, improve operational efficiency, and increase workforce productivity. In combination with an extensive partner network, PTC provides customers flexibility in how its technology can be deployed to drive digital transformation – on premises, in the cloud, or via its pure SaaS platform. At PTC, we don’t just imagine a better world, we enable it.
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