Alliance to provide life sciences customers with computer systems validation, Sarbanes-Oxley compliance
Atlanta — June 16, 2005 — Software company Ross Systems is partnering with solution provider US Data Management (USDM) for computer systems validation and Sarbanes-Oxley compliance in an alliance targeted at the life sciences industry.
Regulated by the Food and Drug Administration (FDA), bio/pharmaceutical, medical device manufacturing organizations and tissue processors must ensure the computer systems they use to create, modify, maintain, archive or transmit critical data operate as intended and meet FDA requirements. For these companies, computer system validation is key to ensuring their systems meet overall business objectives and comply with industry regulations.
Together, Ross and USDM have various customers who have deployed Ross' iRenaissance solution to address the validation needs of both new system implementations and customer upgrades, helping them to accelerate the validation cycle by up to 40 percent. Ross said that through this new partnership its customers now will have access to a "complete solution" from a single provider that has intimate knowledge of both the life sciences industry and the iRenaissance product suite.
Sarbox Compliance Addressed
In addition, complying with the Sarbanes-Oxley accounting reform and investor protection legislation is a challenge for all public companies. Many of the processes and procedures for computer system validation to meet the predicate rules for CFR 21 are nearly identical for Sarbanes-Oxley financial IT system controls and compliance.
Ross and USDM provide an IT audit preparation solution for Section 404 Sarbanes-Oxley compliance. By embedding the same validation methodology to the installation, testing plans for operation and executing performance testing of the Ross iRenaissance financial systems, companies can streamline their Sarbanes-Oxley compliance initiatives at a lower cost, Ross said.
"Ross is an ideal partner, with a strong presence in the life sciences industry and a large network of customers," said Erik Smith, vice president of business development for USDM. "This end-to-end solution for enterprise processes with system validation compliance provides customers with a complete package from one provider at a fraction of the cost."
USDM provides services around computerized system validation, helping organizations ensure that the systems they use are monitored, controlled and capable of performing their intended functions in a reliable and reproducible manner. Designed specifically to fit with the iRenaissance software suite, USDM's validation process enables companies to protect and maintain the integrity of the data, providing documented evidence of quality performance, according to USDM.
Ross Systems is a unit of CDC Corporation.
Additional Articles of Interest
— Is your company getting the most from its supply management function? For a step-by-step look at how to phase in a successful "end-to-end" supply management strategy, read the article "Roadmap to a Comprehensive Supply Management Strategy," an In Depth article on SDCExec.com.
— When ex-Chrysler chief Thomas T. Stallkamp considers cures for what ails American manufacturing, he chooses not to look inside the four walls of the corporation but to the extended enterprise and the relationships that bind a company to its supply chain partners. Read about Stallkamp's take on the collaboration imperative in "No Company Is an Island," the Executive Memo column in the April/May 2005 issue of Supply & Demand Chain Executive.
— P-cards continue to advance, and e-payables solutions are making headway, but the convergence of the financial and physical supply chains is still a work in progress. Read more in "Enabling the Financial Supply and Demand Chain," in the April/May 2005 issue of Supply & Demand Chain Executive.
Atlanta — June 16, 2005 — Software company Ross Systems is partnering with solution provider US Data Management (USDM) for computer systems validation and Sarbanes-Oxley compliance in an alliance targeted at the life sciences industry.
Regulated by the Food and Drug Administration (FDA), bio/pharmaceutical, medical device manufacturing organizations and tissue processors must ensure the computer systems they use to create, modify, maintain, archive or transmit critical data operate as intended and meet FDA requirements. For these companies, computer system validation is key to ensuring their systems meet overall business objectives and comply with industry regulations.
Together, Ross and USDM have various customers who have deployed Ross' iRenaissance solution to address the validation needs of both new system implementations and customer upgrades, helping them to accelerate the validation cycle by up to 40 percent. Ross said that through this new partnership its customers now will have access to a "complete solution" from a single provider that has intimate knowledge of both the life sciences industry and the iRenaissance product suite.
Sarbox Compliance Addressed
In addition, complying with the Sarbanes-Oxley accounting reform and investor protection legislation is a challenge for all public companies. Many of the processes and procedures for computer system validation to meet the predicate rules for CFR 21 are nearly identical for Sarbanes-Oxley financial IT system controls and compliance.
Ross and USDM provide an IT audit preparation solution for Section 404 Sarbanes-Oxley compliance. By embedding the same validation methodology to the installation, testing plans for operation and executing performance testing of the Ross iRenaissance financial systems, companies can streamline their Sarbanes-Oxley compliance initiatives at a lower cost, Ross said.
"Ross is an ideal partner, with a strong presence in the life sciences industry and a large network of customers," said Erik Smith, vice president of business development for USDM. "This end-to-end solution for enterprise processes with system validation compliance provides customers with a complete package from one provider at a fraction of the cost."
USDM provides services around computerized system validation, helping organizations ensure that the systems they use are monitored, controlled and capable of performing their intended functions in a reliable and reproducible manner. Designed specifically to fit with the iRenaissance software suite, USDM's validation process enables companies to protect and maintain the integrity of the data, providing documented evidence of quality performance, according to USDM.
Ross Systems is a unit of CDC Corporation.
Additional Articles of Interest
— Is your company getting the most from its supply management function? For a step-by-step look at how to phase in a successful "end-to-end" supply management strategy, read the article "Roadmap to a Comprehensive Supply Management Strategy," an In Depth article on SDCExec.com.
— When ex-Chrysler chief Thomas T. Stallkamp considers cures for what ails American manufacturing, he chooses not to look inside the four walls of the corporation but to the extended enterprise and the relationships that bind a company to its supply chain partners. Read about Stallkamp's take on the collaboration imperative in "No Company Is an Island," the Executive Memo column in the April/May 2005 issue of Supply & Demand Chain Executive.
— P-cards continue to advance, and e-payables solutions are making headway, but the convergence of the financial and physical supply chains is still a work in progress. Read more in "Enabling the Financial Supply and Demand Chain," in the April/May 2005 issue of Supply & Demand Chain Executive.
- More articles about Ross Systems.
