ERP and quality management integration drives life science manufacturer’s solution for managing regulatory compliance

Santa Clara, CA, Morgan Hill, CA – Expandable Software, Inc., a developer of ERP software and AssurX, Inc., provider of quality management and regulatory compliance solutions announced the launch of joint products and a partnership that brings critical regulatory compliance solutions to medical device and life science manufacturers. This enterprise-level global solution and partnership has already proven fruitful with a first joint medical device customer, ReVision Optics (RVO).

“As RVO prepares for expanded Vue+ commercialization, it is important that our quality systems grow and expand as we navigate through regulatory compliance processes,” said Ali Dahi, ReVision Optics’ V.P. Operations. “As we drive our business priorities in preparation for meeting these requirements, our choice of Expandable’s core ERP with integrated extension to CATSWeb help us incrementally bring functionality on line as our business dictates the need.”

The strategic partnership with AssurX reinforces Expandable’s commitment to providing a complete integrated solution for manufacturers competing in the life sciences industry.  Integration with CATSWeb delivers Expandable customers a powerful quality management solution that provides enterprise-wide visibility of quality issues and processes helping medical technology manufacturers meet the stringent requirements of the FDA and other governing bodies.

“What we’re offering Expandable customers is an extremely attractive entry point to a very robust quality management solution,” said Bob Swedroe, CEO of Expandable Software, Inc. “We’ve found that growing medical technology manufacturers have a distinct need for integrated quality management but often delay or forego the investment because of the typical high cost of commitment. Our partnership with AssurX is aimed at providing customers with a tier-one quality solution, integrated with Expandable ERP, that can be deployed by companies that are anywhere from pre-production to the high growth phase of their expansion cycle.

“Connecting the AssurX quality and compliance management system to the Expandable ERP system provides a complete solution for manufacturers, especially life science companies. This allows manufacturers already using the Expandable ERP system to realize the benefits of integrated quality and compliance process functionality. It also extends four pre-configured, 21 CFR Part 11 compliant processes to Expandable’s ERP customers: customer complaint handling, nonconformance tracking, supplier quality and corrective and preventive action (CAPA) management. We are thrilled that Expandable selected AssurX to provide this integrated functionality,” added Sal Lucido, Vice President, Enterprise Solutions, AssurX.

“Our product strategy is to provide a completely integrated enterprise-level solution that medical technology manufacturers can use to establish sound business practices early in their growth cycle,” said Dennis Payton, Expandable’s director of product marketing. “Our relationship with AssurX allows us to provide comprehensive solutions that meet the very demanding long-term needs of medical technology manufacturers at an investment level that is affordable for growing companies.”

About Revision Optics

ReVision Optics, Inc., (RVO) is a privately held corporation headquartered in Lake Forrest, California. The company’s main focus is the research and development of minimally invasive implantable devices for the restoration of reading vision.

ReVision Optics’ current product portfolio includes the Vue+ corneal microlens. Vue+ is a tiny contact lens-like device that is placed just beneath the surface of the eye. The lens is made from a proprietary, optically clear, biocompatible hydrogel that is similar in nature to the natural cornea. The lens is designed to slightly change the shape of the corneal curvature to improve near or reading vision, decreasing the need for reading glasses.

The company is actively pursuing regulatory approvals and market opportunities for the Vue+ worldwide. The Vue+ has received CE mark and is approved for sale in Europe. For more information, please visit www.revisionoptics.com.

*Caution, the Vue+ is an Investigational Device and is limited by United States federal law to investigational use only.

About AssurX

AssurX, Inc., provides highly regulated organizations with enterprise quality management and compliance solutions. With a choice of OnDemand (SaaS) or OnPremise (licensed) software delivery options, AssurX’s flexible, all-in-one system automates quality and compliance processes so issues can be centrally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. More information is available at www.assurx.com.

About Expandable

Expandable Software, Inc. develops, markets and supports an enterprise resource planning (ERP) software suite designed to help executives and managers of fast-growing companies maximize business performance by maintaining visibility and control of manufacturing operations. Expandable’s fully integrated accounting, engineering and manufacturing modules provide a solid back office foundation while CRM, e-business, and supply chain functions deliver front office tools to manage business relationships, and streamline transactions.

The Expandable system is targeted to medical device, high tech and other manufacturers who need a dependable business foundation that will support their growth all the way to the billion dollar mark.

Expandable is located in California’s Silicon Valley.  More information is available at www.expandable.com.