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Medical Device Manufacturer TranS1 Goes Live With FourthShift Edition for SAP Business One

Manufacturing Processes Successfully FDA-Validated During Implementation

MINNEAPOLIS, May 9 /PRNewswire-FirstCall/ -- Medical device manufacturer TranS1 has gone live with SoftBrands' FourthShift Edition for SAP Business One as its manufacturing ERP system. SoftBrands, Inc. , a global supplier of enterprise application software, is a global ISV partner of SAP AG.

Based in Wilmington, N.C., TranS1 develops, manufactures and distributes products used in minimally invasive surgical procedures to treat low-back pain. The FourthShift Edition installation helps ensure TranS1's manufacturing processes comply with Food and Drug Administration regulations.

"Executing the validation of FourthShift Edition as part of the roll-out, rather than afterward, let us reduce our regulatory risk and get to work right away," said Rick Randall, president and CEO of TranS1. "The FourthShift team made the validation process quick and painless."

The FourthShift Edition validation process models the FDA Quality Systems Inspection Technique (QSIT) to help ensure that the business system as implemented meets the requirements of regulated companies. The FourthShift Edition validation program is also "risk-managed." It identifies the critical points at which FourthShift functions and data records intersect with specific cGMP regulatory requirements and focuses documentation and audit/test coverage at those intersections, rather than giving equal attention to each FourthShift Edition function.

In conjunction with FourthShift Edition, TranS1 will run the global alerts application FourthShift VisiWatch, an event-driven system that lets manufacturers monitor important events and respond without manual intervention. FourthShift VisiWatch can extract, transform and import data from and to various sources, and its VBA-compliant scripting engine enables event responses to be customized for each company's specific business needs.

"FourthShift Edition has the lot trace, security and auditing features that we need from our ERP system," Randall said. "SoftBrands' Validation Service gave us the peace of mind that our business system is operating as intended."

About SoftBrands

SoftBrands, Inc., is a leader in providing software solutions for businesses in the manufacturing and hospitality industries worldwide. The company has established a global infrastructure for distribution, development and support of enterprise software, and has approximately 5,000 customers in more than 100 countries actively using its manufacturing and hospitality products. SoftBrands, which has approximately 825 employees, is headquartered in Minneapolis, Minn., with branch offices in Europe, India, Asia, Australia and Africa. Additional information can be found at http://www.softbrands.com/.

About TranS1

Founded in 2000, TranS1, Inc. is a privately-held medical device company focused on developing innovative, minimally invasive surgical procedures for treatment of lower back pain. For more information, please visit http://www.trans1.com/.

Contact: Mark Palony 612-851-1500 [email protected]

SoftBrands, Inc.

CONTACT: Mark Palony of SoftBrands, Inc., +1-612-851-1500,
[email protected]

Web site: http://www.softbrands.com/
http://www.trans1.com/

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