Spine Treatment Device Maker Leverages QAD ERP Solutions Built for Manufacturing to Grow its U.S. Market and Meet FDA Compliance Standards
Cardiff-by-the-Sea, CA, September 18, 2012 — Strategic Information Group (Strategic), a full service provider of enterprise technology, quality and regulatory management solutions, today announced that medical technology developer Benvenue Medical, based in Santa Clara, CA, has successfully gone live, on time and on budget, with QAD Enterprise Applications in a U.S. Food and Drug Administration(FDA) validated cGMP environment, specifically addressing the demands of CFR 21 Part 11 validation requirement.
Benvenue Medical chose Strategic as its QAD implementation partner to take advantage of Strategic’s proven track record of helping fast-growing life sciences enterprises leverage QAD manufacturing ERP software to meet business goals, as well as its Strategic’s ability to ensure the full validation and compliance of the company’s new ERP system. The company expects the new QAD solution to support its global growth trajectory as it continues to develop and commercialize new products.
Benvenue Medical designs and manufactures medical devices for use in minimally invasive spinal therapies, primarily for the treatment of vertebral compression fractures (VCFs).The company’s Blazer™ Vertebral Augmentation System is commercially available in the U.S.; its Kiva VCF Treatment System is currently undergoing clinical trials in support of 510(k) market clearance from the FDA. Already commercially available in Europe, The the Kiva VCF Treatment System has been used to treat more than 800 VCFs globally.
QAD and Strategic Help Benvenue Medical Become a More Effective Enterprise
“Strategic brings us a track record of success within the medical device industry — spine treatment companies in particular,” said Oliver Brouse, vice president of Finance for Benvenue Medical. “Strategic’s expertise with QAD Enterprise Applications ensures Benvenue Medical can fully leverage QAD ERP solutions.”
“QAD enterprise applications and related services and solutions from Strategic give companies like Benvenue Medical a cost-effective, industry-specific ERP solution,” said Doug Novak, president and CEO of Strategic. “QAD technology and expertise in life-science manufacturing helps Benvenue Medical manage risk while meeting stringent compliance requirements.”
QAD ERP “Go Live” in Less than Three Months
“This is my fifth major QAD ERP implementation at a medical device manufacturer,” added Mr. Brouse. “QAD delivers the best enterprise applications available to meet our needs. With Strategic as our implementation partner, Benvenue Medical’s North America operations can run at top performance, meet FDA compliance mandates, and keep the company on track to our growth objectives.”
The initial implementation phase included QAD Distribution, Manufacturing and Finance core modules, Service and Support Management, Customer Consignment, Cytak Sales and Use Tax interface, and bi-directional integration between QAD and FedEx. QAD .NET User Interface, allowing access to users using a browser or mobile device, gives Benvenue Medical a user-friendly, interactive solution that delivers efficient workflow integration and flexible access to data on demand.
The Strategic team brought the project from planning to go-live in less than three months. They deployed Strategic Software Validation Master Plan to ensure fast, accurate validation.
“The entire Benvenue Medical team is very pleased with the ease and speed of the implementation. The Strategic team collaborated well with both our executive team and our users, making sure we have the best processes in place and that our end-users have adequate training to make the most of our QAD solution,” said Mr. Brouse.
Strategic provides specialized software validation products and consulting services in support of QAD applications to companies looking to better leverage their ERP investment. Strategic Validation Master Plan helps with FDA CFR 21 Part 11 validation requirements, streamlining validation for regulatory compliance, and allowing companies to implement and upgrade QAD applications with speed and ease.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. is advancing spine repair through the development of proprietary, minimally invasive surgical and interventional solutions. The company is privately held and funded by Versant Ventures, De Novo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $1.6 billion globally. For more information, visit www.benvenuemedical.com
About Strategic Information Group (Strategic)
About Strategic With more than 17 years of experience successfully delivering QAD consulting and implementation services, and a special dedication to the life sciences industry, Strategic will help customers comply with global and FDA regulations by validating their QAD solutions. Strategic works with start-ups, multinationals and market leaders to implement their systems on time and on budget, helping them maximize the value of their enterprise technology. For more information visit www.strategic.com