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Prominent pharmaceutical validation and compliance specialist embraces Rev-Trac 5.0 change control application
Boston, MA -- May 17, 2005 -- Revelation Software Concepts Pty Ltd (RSC), member of the SAP Software Partner program and creator of the Rev-Trac change control application for SAP solutions, today announced at SAPPHIRE '05 a new marketing partnership with QA Edge, prominent Computer Validation and regulatory compliance specialists for the huge, FDA-regulated pharmaceutical and medical devices markets.
Under the agreement, QA Edge will market Rev-Trac 5.0 to its growing client list of companies regulated by the U.S. Food and Drug Administration (FDA) under provisions of 21 CFR Part 11 and using SAP solution-based business information systems. The continually evolving FDA regulation establishes stringent standards of data security, data integrity and traceability in one of the world's largest vertical markets. U.S. consumption of pharmaceuticals and devices is estimated to exceed $250 billion in 2005, accounting for some 48% of the world's total.
QA Edge will market Rev-Trac 5.0 change tracking and management software for SAP solutions as the optimum way for FDA-regulated companies using SAP solution-based systems to demonstrate 21 CFR Part 11 compliance, as well as compliance with other regulations pertaining to Computer Validation. Compliant companies must be able to prove they have control over their computer systems. Rev-Trac enables change control as a process with a mechanism for documenting change approvals.
"An increasing number of our clients use SAP solutions to manage critical information in this tightly regulated market," said Joseph Schenk, president and founder of QA Edge. "Rev-Trac optimizes their operation both from the compliance angle and from an operational excellence angle. Should a fix be required, Rev-Trac use reduces the mean time to repair (MTTR) by accelerating the investigative process to identify the cause. Since about 80 percent of incident repair reflects time to track down and identify causes, Rev-Trac dramatically cuts both the time and the cost."
"With companies relying increasingly on SAP solutions, QA Edge will provide a crucial link into this huge vertical market and ensure they hear how Rev-Trac minimizes costs of information tracking and regulatory compliance," commented Rick Porter, VP Business Development, Revelation Software Concepts. "We are delighted that a rising star of Computer Validation and compliance services has selected Rev-Trac 5.0 for SAP solutions as the optimum change control software for their national and international customers who make pharmaceuticals and medical devices."
For more about the Computer Validation services of QA Edge, including a discussion of the 21 most common problems in Computer Validation and Part 11 compliance, see www.QAedge.com. More on Revelation Software Concepts and its products, including Rev-Trac 5.0, can be found at www.xrsc.com and this week at Booth #1363 at SAPPHIRE.
About QA Edge
QA Edge, Inc., headquartered in Wilmington, DE provides its customers with real-world strategies to avoid costly mistakes through a diverse range of Computer Validation and Part 11 training and services, "Making Computer Compliance Easy." The company's knowledgeable and experienced professionals provide clients the advantage needed in meeting today's regulatory requirements. Recognized in 2005 with a coveted Philadelphia 100 Award as one of the fastest-growing, privately held companies in the Philadelphia region, the individualized solutions crafted for clients by QA Edge carry the industry's only ironclad corporate guarantee: Documents authored by QA Edge staff will pass any FDA inspection. In the unlikely event the FDA has an issue, the document is corrected immediately at no charge. More about QA Edge, its products and services can be found on the web at www.QAedge.com.
About Revelation Software Concepts
Headquartered in Melbourne, Australia, Revelation Software Concepts Pty Ltd has earned the trust of some of the world's largest corporations since 1997, developing robust software applications that help customers obtain maximum competitive advantage from their SAP solutions. An SAP Software Partner, RSC's business strategy is 100% focused on SAP solutions. RSC's change control tool Rev-Trac for SAP solutions and cross-application reporting product xReports demonstrate the company's preparedness to think 'outside the box' when developing superior software solutions. Technologically innovative, both products reflect RSC's commitment to creating solutions that are simple to use and promote business transparency and collaboration. Rev-Trac 5.0 is an SAP-certified add-on for SAP R/3 Release 4.6 and SAP R/3 Enterprise Release 4.7 and is "Powered by SAP NetWeaver". For more information, visit www.xrsc.com.