Genilogix Announces Mercury Verification of Genilogix Validation Accelerator With e-Signature

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Genilogix Receives Verification for Integration of Solution to enable FDA-regulated companies with Mercury Business Technology Optimization Offering

Today, Genilogix announces that the integration between Genilogix Validation Accelerator and Mercury TestDirector™, a part of Mercury Quality Center™, has been validated by Mercury Interactive Corporation, the global leader in business technology optimization (BTO) software.

The Validation Accelerator was developed by Genilogix in response to the growing demand for automated testing tools by Life Sciences companies. The Validation Accelerator provides e-Signature capabilities and other components required for FDA compliance.

The Validation Accelerator with e-Signature is the most recent addition to the Genilogix family of tools developed for FDA-regulated customers. These tools enable clients to leverage the power of Mercury’s best-of-breed, off-the-shelf software to optimize the computer systems validation process. Project deliverables include a configured project template which mirrors the client’s unique validation process, enabling Mercury TestDirector to be the test management hub for test requirements, deviations, and tests (both manual and automated) for FDA validated applications.

The Validation Accelerator with e-Signature provides the following components:

  • e-Signatures. This facilitates compliance with 21 CFR Part 11 requirements and aligns the functionality of Mercury TestDirector with the client’s internal validation procedures.
  • General Validation Documents to include: Validation Master Plan, System Requirements Specification, IQ, OQ, PQ, Requirements Traceability Matrix, and SOP Checklist.
  • Validation consulting services to prepare the validation documents and execute/document the test protocols

Please Note: The e-Signature component is available separately through Genilogix.

"We are very pleased with our decision to implement the e-Signature solution offered by Genilogix,” said Richard Bodnar, O&I Project Manager at Bayer HealthCare. “This functionality was essential in order for us to move forward with Mercury Test Director 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 Mercury 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 Mercury. “Genilogix's Validation Accelerator helps our joint customers optimize the business outcomes of IT.”

About Genilogix

Genilogix is a leading technology services company with a mission to enhance our customer’s financial performance and create long term value through optimization of business applications. Genilogix provides solutions for Quality Assurance, Business Continuity, IT Governance and Application Performance Management in a large number of vertical markets.

The Genilogix Life Sciences practice is focused on deploying offerings to lower the cost and increase the financial return when performing Computer Systems Validation.

About the Mercury Alliance Program

The Mercury Alliance Program is designed for companies offering best-of-breed services and value-add products that leverage Mercury business technology optimization (BTO) offerings and best practices. Mercury Alliance Partners provide BTO consulting, implementation services and products that complement Mercury’s offerings in IT governance, application delivery, and application management. Mercury Alliance Partners' offerings extend Mercury BTO Enterprise,

the industry’s first integrated suite of BTO offerings designed to help customers optimize the business outcomes of IT.

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