Electronic signature solution for HP Quality Center 10
Release on: January 4th, 2010
Pittsburgh, January 4th, 2010 - Genilogix announces the availability of QC eApprove, a solution that provides electronic signatures, controlled workflow and management capabilities required to enable compliance with 21 CFR Part 11 for HP's Quality Center.
QC eApprove, along with HP Quality Center, provides a powerful tool to manage validation testing throughout an application's lifecycle. Extending the capabilities of the Genilogix Validation Accelerator for HP Quality Center, QC eApprove improves existing functionality and takes advantage of new features introduced in Quality Center 10.
Developed based on customer feedback and new GAMP5 guidelines, "QC eApprove is a result of a significant R&D effort" states Jason Tepfenhardt, Director of Operations for Genilogix Life Sciences.
"With the enhanced project configuration and workflow customization capabilities Genilogix can provide Life Science clients with greater flexibility to adapt QC to their computer systems validation process. QC eApprove can be provided with a complete set of executed validation documentation which reduces the effort to validate the tool itself allowing for quick deployments."
In addition, QC eApprove integrates Siemens ID Center solution for Biometric ID management and authentication. "Since FDA regulated customers are drawn to ID Center's flexible options for authentication, including the use of multiple modes of biometrics like fingerprint and palm-vein, it's very logical fit for Genilogix's QC eApprove," stated Stefan Young, Business Development Manager at the Siemens Biometrics Center.
"We are very pleased with our decision to implement QC eApprove," said Richard Bodnar, O&I Project Manager at Bayer HealthCare. "This functionality was essential in order for us to move forward with Quality Center as our strategic testing tool within Bayer HealthCare North America. Through our partnership with Genilogix, we were able to meet all of the CFR Part 11 requirements and customize the design to meet our existing internal procedures. This provided a significant savings in both time and costs."
"Using Quality Center, Life Sciences companies can validate automated business processes and produce the associated documentation needed to meet strict FDA regulations," said Rajesh Radhakrishnan, Vice President of Application Delivery products at HP. "Genilogix's QC eApprove helps our joint customers optimize the business outcomes of IT."
An HP Platinum Partner, Genilogix is an information technology company that optimizes the quality, performance and availability of mission-critical applications. Genilogix Life Sciences serves the FDA-regulated industry by combining application lifecycle management and regulatory compliance expertise to implement test automation tools so clients simultaneously meet their regulatory challenges while reducing costs.
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Original Press Release: Genilogix Announces Availability of QC eApprove