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Quality Digest

FDA Compliance

Genilogix Releases Validation Accelerator with e-Signature

Published: Wednesday, October 26, 2005 - 22:00

Responding to a growing demand for automated testing tools by life-sciences companies, Genilogix LLC recently released its Validation Accelerator with e-Signature. The device is designed to work with Mercury’s TestDirector for Quality Center product, which enables clients to leverage optimal power in the computer-validation process. The Validation Accelerator with e-Signature provides the following components:
  • E-signature, to comply with FDA 21 CFR Part 11 requirements
  • General validation documents, including a validation master plan, system requirements specification, installation qualification, operational qualification, performance qualification, requirements traceability matrix and SOP checklist
  • Validation consulting services to prepare documents and execute/document the test protocols

The e-Signature component is also available separately though Genilogix. For more information, visit www.genilogix.com.


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